While things were going okay, I realized that it was a path that I stepped on to 8 years ago by accident, not by design.  While the trek has been interesting, it hasn’t really taken me where I want to go.  I never did have a big desire to sell foam pump bottles, malibu tubes and powder shakers … it just sort of happened. One day I decided to host a co-op buy on foam pump bottles, the next month I decide I could sell them, the next month I’m in business, and a year later I have a store and employees

Recently I took stock of all the different paths I am walking, the directions they are taking me, and – most importantly – where I want to go.  It’s amazing how easy it is to start following  “interesting distractions” rather than staying on course and getting where you want to go.

I have several general areas that I want to focus in life:  family, handcrafted soap industry, Scientology studies, genealogy research, our ranch and website programming (not necessarily in that order).  I’m gearing up for my New Year’s resolution to stay more focused on them, center my activities (including income generation) around them, and remove those interesting distractions. I expect the next 12 – 24 months to be a lot more fun!

As for ForSoapmakers.com, if you need to stock up on any of our primary products (foam pump bottles, malibu tubes, powder shakers, bulk body powder or other items), all orders received by December 10th will be filled before we close the doors.  (Orders received after December 10th will be filled on a first-come, first-served basis until stocks are gone or December 31, whichever comes first.) Oh, and the domain of www.forsoapmakers.com is available for sale (email me if you are interested).

For some background, the 1994 Northwest Forest Plan was set up to provide income to rural Oregon counties from logging done on federal land within the county (which, of course, doesn’t pay any property taxes).  The revenue was KEY to the survival of the counties.  Due to environmental pressures, logging plummeted; very little federal land is being logged (at least in our county).  Congress was supplementing with payments to help cover costs. The original supplementation ran out a few years ago and we were looking at – well, basically shutting down most services in our county.  The sheriff was quoted in the paper as saying that they won’t have funding and will have to cut services – unless it’s a matter of life and death, they won’t respond; get a big dog.

However, the reduction of logging under Northwest Forest Plan ALSO affects all of the small private landowners.  Because the logging on state and federal land has decreased markedly, logging companies have gone out of business and mills have closed, reducing the log buying market and lowering prices for logs.  As an example, the price for logs is about 1/3 of what it was 4 years ago, and it costs MORE to log the same amount of timber (primarily due to fuel prices).  This year we JUST barely got a contract in time to get logging done this year before the rain.  Without it, things would have been VERY, VERY tight over the next 12 months.The following is Rep. Richardson’s newsletter, in full.  It’s an interesting read.

Ending Federal Timber Payments to Oregon;
Economic Collapse of Oregon Rural Counties, A Statewide Concern

I am Dennis Richardson, a Co-Chair of Oregon’s Joint Senate-House Ways & Means Committee, and I write this newsletter on issues of significance for all Oregonians.

If you aren’t hungry or worried about your next meal as you read this, be grateful.  One of every five Oregonians is now receiving food stamps.

If you aren’t checking Craigslist for a job or sending out resumes, be thankful.  Almost ten percent of Oregon’s workforce is in the unemployment line.

Somber statistics, but the real tragedy, the deepest devastation lies in Oregon’s rural counties. And it’s about to get worse, much worse.

Notwithstanding the bipartisan coalition of Oregon’s federal elected officials who are working to extend federal timber payments, U.S. Agriculture Secretary Tom Vilsack predicted extending benefits is not likely to occur.  Secretary Vilsack during his recent visit to Oregon stated that the federal program that provided as much as $253 million a year in payments to rural Oregon counties, the Secure Rural Schools Act, will not survive the Congressional super committee’s work to cut $1.5 trillion from the federal budget deficit.

If you live in an urban area and you still have a job and a home, maybe you don’t care that this will likely bankrupt at least two Oregon counties.  Maybe you don’t have time to worry about rural unemployment rates that have hovered near 20 percent for almost two decades.

But if you do care, then before you leave for work or go out for lunch, take a close-up look at poverty in our state; take a moment to google Curry County or Coos County, or for that matter just view the sweeping satellite image of our state – nearly half of which is blanketed with riches, deep green forests—Oregon’s richest natural resource.

And yet these are Oregon’s poorest areas, where methamphetamine destroys already broken lives, where hopelessness evicts the young and ambitious, where urban idealism has outspent and outlawed rural initiative.  Where generations of hard-working timber families once labored and thrived, depression now is a way of life.

Imagine if you lived in the midst of the natural resources necessary to save yourself and your family, and were ordered to abandon your tools, your dreams, and your community. Consider how demoralizing to be a fourth generation logger, out of work because of legal challenges to timber sales, who must stand by and watch Oregon’s forests in thick, black, carbon-laden smoke, as millions of acres are consumed in raging forest fires.  It wasn’t intended to be this way.

Rural Oregonians acted in good faith and believed in their elected leaders when they helped negotiate President Clinton’s 1994 Northwest Forest Plan, but since then teams of environmental lawyers have blocked the timber sales, closed the mills, and thwarted alternative recreation plans, leaving rural Oregon underemployed and dependent on government hand-outs.

How could the urban elected officials who set the agenda for our federal forests turn away from our most plentiful renewable resource?  How could they ignore our comparative advantage over other states?  Who is responsible for Oregon’s rural poverty, high unemployment rate and declining income?  How did this happen?

During the 1980s and 90s timber revenues from federal forests in rural Oregon counties plummeted.  Well-funded “eco-elites” [If this term offends you, see Note below.] shut down Oregon’s timber harvests by obtaining federal court rulings over the endangered species listing of the spotted owl.  More than 100 mills closed.  Thousands of family wage jobs were eliminated, drying up incomes and businesses in small mill towns across our state.  Annual timber harvests now hover at around 10 percent of levels associated with a more thriving Oregon.  Ironically, Oregon’s population of spotted owls continues to dwindle.

Faced with economic disaster from the loss of timber harvest revenues, rural counties turned to Congress for a solution.  Rather than correcting the misuse of the Endangered Species Act, Congress approved the Secure Rural Schools Act, which temporarily supplanted the lost income that once funded rural schools, government, and other essential services.
Instead of continuing to fund county services from timber harvest revenues, rural counties were paid hundreds of millions of dollars in federal welfare payments.

The counties were ordered to develop alternative economic plans.  Having achieved their goals of making Oregon’s rich forests of renewable timber legally off-limits and unavailable to be managed or harvested, Portland’s urban eco-elites promptly turned their backs and abandoned the counties to fend for themselves with meager resources.

For the past decade, politicians and the environmentalists have allowed rural Oregon counties to deteriorate and become ever more dependent on government handouts.  Now, in the face of massive federal deficits, nobody wants to defend any longer what are essentially welfare payments to counties in 40 states.

Portland and Oregon’s other major cities should wake up.  The last federal timber welfare payment checks are being issued, and they will mark the end of the primary source of revenue to some of Oregon’s rural counties.  There will be consequences felt in Portland, Salem and Eugene from the bankruptcy of Oregon rural counties.  As the urban eco-elites watch placidly from the sidelines, they should realize this rural economic meltdown will financially affect their schools, their county services, and their tax rates. State government is already being asked to intervene.  What will be the cost and how should we respond?

The solution is clear.  Ignoring Oregon’s vast timber resources is a failed policy and must be reversed.  Democrat leaders now must “man-up” and face their coalition of environmental supporters and say, “No more lawsuits.  Our neighbors are suffering; our rural communities are collapsing; our rural counties must be saved.  We must moderate our forest policy.”

Action is needed now.  Words are not enough. The federal government controls 53 percent of Oregon land, and rural counties depended on effective and productive management of those resources. They have been abandoned and betrayed.

The truth stares rural folks in the face day and night. There are no alternatives. There is no replacement economy. There is only the forest—one of the richest, greenest, fastest growing forests in the world.

There is only one solution – it’s vast, green, and sustainable.  Oregon needs a new forest timber policy.  The particulars of a new Oregon timber policy must be hammered out between the state and federal government.  It is not working to have the future of Oregon’s rural counties controlled three thousand miles away in Washington, D.C.

What should Oregon’s new timber policy look like?  One proposal is to place control of Oregon’s federal forests with the counties in which they are located.  In addition, to provide funding to Oregon’s revenue-starved timber counties Oregon’s Congressional Representatives Peter DeFazio and Greg Walden have proposed offering long-term leases on up to 1 million acres of Oregon’s federal timber land that is currently managed by the Federal BLM. A third idea is to have Oregon’s federal forests placed in a trust with Oregon assuming management and control of the timber assets.

Regardless of the final terms of the new Oregon timber policy, safeguards must be included that will stop the use of our federal courts as an eco-elitist weapon against responsible timber harvesting.

The time has come to reopen Oregon’s forests in a responsible manner. The time has come to reclaim our bounty, our birthright, and rebuild Oregon’s natural resource-based economy.  The economic future of both rural and urban Oregon depends upon it.

Sincerely,

Dennis Richardson
State Representative

Interesting, and unfortunate, how so many times a solution for one thing becomes a problem later. I am concerned about the very many situations in which we have legislation that has gone from solution to problem. I hope we will be able to fix it without new problems from the new solutions.

It’s amazing how many things in my life revolve around the ability to go on line (with a real, not dial-up, connection).  I can read and respond to email through webmail using my system up here on the landing (but I can’t respond to email I’ve already downloaded).   And I can surf the net just fine from up here, although somewhat unsecurely.

But for things that need programs on my computer, I’m out of luck.  I can do my accounting, but can’t process credit card payments or access my bank account.  I get online statements from my credit cards , but can’t access them to make a snail-mail payment or pay online.  I can make soap and products, but my recipe system is online and I can’t get to it.  I get orders for my book through PayPal – but I can’t get logged in to retrieve them.  And I use Stamps.com com for shipping, but can’t get online to fill my account or print shipping labels.

For all of July I moved my whole computer system into town and was driving in each day to work.  Must say, I DO NOT like “commuting”.  Driving 12 miles each way is probably less than most people have to commute, but I had to drive 8 of those miles on a gravel road dodging log trucks!  I finally took everything home last week because I thought we were just a few days from having an internet connection.

We had a great connection at a very reasonable price ($50 per month for excellent speed and no band-width restrictions) through Rural Access Internet, an internet access system using radio transmissions that a local computer guy set up.  Unfortunately, he passed away early this year and his wife decided to discontinue the service.  They were to shut down June 30th, but they were cut off a few days early, and our service quit on the 28th.

Since that time we’ve been looking at options.  For those of you in cities, the options are easy – call the cable company and get a hook-up.  Out in the sticks (we’re not actually in the middle of nowhere, but you can see it from out house), the options are a little different.

First we called Verizon to see if we could get connected through our cell phone or Xoom.  Nope.  We just BARELY get cell service at our house, not enough for a stable connection, and the bandwidth is limited to 5G per month – not enough for Jere and I to actually work.

Next we tried DirecPC (HughesNet).  We had that before, and my daughter has it now.  To get a usable level of speed and bandwidth, it would cost about $350 per month — for about 1/2 the speed we had with our previous ISP, and still just barely enough bandwidth.

We checked with Frontier Communications, who recently bought the Verzion phone service here – partly on the basis that they would provide internet access to rural areas.  Nope.  They won’t have the infrastructure set up for internet in our area for at least a year, and even then it’s unlikely they will string a line as far out as we are. (Just as a note, the phone infrastructure here is so far behind that we can’t even get voice mail services on our land-line phone!)

ComCast, the local cable provider?  They aren’t going to expand out to our area.  Ever.

Then we went to the ISP that was providing the backbone connection for Rural Access Internet before they shut down.  Ah-ha!  Possible option – a T1 line, using existing phone cable   “Of course it can be done,” they said.  No problem.  Only $500 per month, but great speed and bandwidth.  Now, 6 weeks later, they found out that the equipment needs to be “upgraded” and we are still waiting to see what that would involve.

But there IS good news.  We’re not the only ones in this position and good old country ingenuity is coming through.  A local web guy, Dave, is setting up a new system, similar to Rural Access Internet, but better and faster.  Luckily, from this very landing we can see our house and my daughter’s house, and also Dave’s house (8 miles away) and the backbone connection he’s using (10 miles) – which means that the radio signal will reach here and from here to our house and Liz’s.

It’s been a process getting everything set up, though – and it’s still not working (YET).  It took Dave a while to get the radios all talking and relaying information, but he has internet access at his house now – the first step.  We know the system works.  We have to pole up, the incoming radio and outgoing wi-fi units ready, batteries (4 six-volt units), lockable job box to secure everything … just need the power converter.

And the best news?  As I write this, Jere is cruising down the freeway to Grants Pass (6 hours round trip) where he’s picking up the solar panel(s) and converter.  He’ll be back by 6 or so, and tomorrow morning everything is supposed to get attached, pointed in the right direction and powered up.

By this time tomorrow I hope to have an update – posted from my desk in my house, using my computer.  And once again I’ll be able to work in my pajamas!

Update – August 9, 2001, 8:27pm – Most of the day was spent getting the radios, batteries, solar panels and the infamous converter hooked up.  Everything seemed to go fine … but no power to the radio.  After searching online for help (through the Xoom on the landing) it turns out the radios use non-standard POE (that’s “Power Over Ethernet”, I recently learned) to keep their system “proprietary” (read that as “secret” and a way to sell more add-ons).  In order to make THAT work, we need a simple $8 gizmo, only available from the radio company.  It’s ordered, with overnight shipping; ships tomorrow and it will arrive on Thursday.

And the internet is lost for a few more days, all for the want of a  …. POE converter.  Would be a lot easier if it was just a horse shoe nail.

Personally, my political philosophy tends toward opposing ANY additional regulation of any kind in any industry or field. However, I am also pragmatic, and realize that stopping the government from issuing new regulations is, at this point, a relatively futile endeavor.

Unfortunately, the bottom line is that sooner or later, there will be legislation that affects cosmetic regulation. It’s too much of an issue to be bypassed for very much longer, as evidenced by the attempts over the last several years. We’ve seen that each attempt builds on past tries, gradually changing the proposed legislation. Likely that process will continue until something passes.

That being the case, the best I can hope for is that that whatever regulation comes down that would/could/should affect me and my business is the least restrictive and most sensible as possible.

What does that mean to me, as relates to the Safe Cosmetics Act of 2011?

Do I support safe cosmetics? Yes – that’s why I started making handcrafted soap and cosmetics in the first place!

Do I want harmful ingredients or byproducts (trace or otherwise) in the cosmetics I make? Definitely no.

Do I think there ARE harmful ingredients or byproducts in some cosmetics on the market? Well, possibly. I see reports about phalates and formaldehyde and other potentially harmful ingredients. I’m not enough of a chemist or medial researcher to have a definite opinion about how harmful they may be, but I don’t want them in MY products and I would like to know if they are in cosmetics I purchase, so I can make an informed decision about purchasing them or not.

Of course, when speaking about something being “harmful,” it’s relative.  Everything can be harmful in high enough quantities and conversely, everything has a level below which it is not harmful at all.  Certain things, like salt and water, for example, are “harmful” (even deadly) and too high quantities; but on the other hand, you can’t live without them. So determining if something is “harmful” requires realistic evaluation of what the safe limits are and working from that.

Would I like a publicly accessible source of information about potentially harmful ingredients? Yes – that would be helpful to me, both as a manufacturer and as a consumer.

Who do I think should determine the safety of cosmetic ingredients? I think the manufacturer of the ingredient should test for and know the safety of the ingredient they produce and when they sell those ingredients to suppliers they should provide that information so it can be passed on to me, so I can make an informed decision on using the ingredient or not.  That safety information should also be available to the public so a consumer can make an informed decision as to what cosmetic(s) she purchases.

However, reliance on a manufacturers evaluation of the safety of a product they sell has been abused in the past in other industries (drugs, pesticides, food, etc).  Relying on the FDA to make the final determination hasn’t always worked, but on the other hand it’s the only alternative available.  I don’t have a better idea.

Should I have to test the products I manufacture for ingredient safety? No, provided I have the ingredient information from the supplier and am using ingredients that have been determined to be safe.

Should cosmetic companies have to register with the FDA? It goes against my “less restrictive regulations” political stance, but I can see how turning the voluntary registration program into mandatory registration is likely to be the way the wind is blowing.  It would provide funds to the FDA.

Should small (micro) businesses be exempt from registration? Definitely, yes.  Micro-businesses have a minuscule impact on the on the total quantity of cosmetic products on the market and generally use existing ingredients (they rarely, if ever, “invent” ingredients).

Should cosmetic manufacturers have to register their products and their ingredients with the FDA? Again, it goes against my “less restrictive regulations” political stance, however, I can see that it might be a way for the FDA to get the information about what ingredients are actually in use so they can realistically set priorities for determining what’s “safe”.

Should small (micro) businesses be exempt from reporting every product and ingredient? Definitely, yes.  Again, micro-businesses generally use existing ingredients and therefore wouldn’t be a source of any additional information on ingredients in use.

Should the use of “flavor” and “fragrance” as ingredients be eliminated (with all components needing to be listed)? The jury is still out for me on this one.  I have no real information, but I expect there may be many, many ingredients in one fragrance, and I do feel that a company that develops a product (fragrance or otherwise) should be able to protect the formulation. However, if there IS something in a fragrance that is potentially harmful, in general I think consumers have a right to know.  I’d also like to know so I can make informed decisions about what I put in my products.  On the other hand, I like being able to say “fragrance” – it is SO much easier than listing all the components.

Maybe there’s a middle ground that can be reached that will still inform and protect cosmetic consumers, inform cosmetic manufacturers, but still allow fragrance manufacturers to keep their proprietary information.

Do I support existing cosmetic labeling regulations? Yes, I do.  I think it’s important that consumers are able to see what’s in a cosmetic so they can make an informed decision about whether to buy or use it.

What about identifying “contaminants”? Unfortunately, the word has several definitions depending on how it’s used.  There’s a big difference between an innocuous “contaminant” (like minerals in water), a harmful “contaminant” that is in or created within a cosmetic or a naturally occurring component in a botanical.

As far as I’m concerned, innocuous contaminants shouldn’t need to be addressed through legislation.  Naturally occurring components in a botanical are what they are, and also shouldn’t be addressed through legislation.  However, I know the EU does have restrictions on some naturally occurring botanical components and it’s not unlikely that similar restrictions will occur in the US.

As for actually harmful components (either added as ingredients or as a by-product of the reaction between ingredients) that end up “contaminating” a product – yes, I do think those should be identified, although the level at which they are considered “harmful” should be clearly identified.  As noted above, everything is harmful at some level or another and nearly everything has “tolerable limits”.

The Future

I don’t know if the Safe Cosmetics Act of 2011 is going to pass.  In this legislative environment, with all the other things going on in Congress, it’s anyone’s guess.  It’s a long road from where it is now to getting passed and implements and the regulations amended.

So far, as mentioned above, this bill is better than the last one.  If it moves forward, I hope to see it made even better through the legislative process.  If it dies at some point, then I hope all the progress will be moved into whatever comes next.

I want to be (and plan to be) involved in the legislative process.

Marie

Like I say about labeling, “It isn’t COMPLICATED, but it is DETAILED.”  If you have your raw materials correctly logged and labeled, and your recipe/formulation with the procedures written out (see Part 2), then you already have most of the information needed for your recordkeeping.  As an added bonus, if you have been calculating the cost of each ingredient when it comes in, you’ll also be able to track your exact cost for each batch and individual product.

7. Records.

Check whether control records are maintained of:

• Raw materials and primary packaging materials, documenting disposition of rejected materials.
• Manufacturing of batches, documenting the:
  1. Kinds, lots and quantities of material used.
  2. Processing, handling, transferring, holding and filling.
  3. Sampling, controlling, adjusting and reworking.
  4. Code marks of batches and finished products.
• Finished products, documenting sampling, individual laboratory controls, test results and control status.
• Distribution, documenting initial interstate shipment, code marks and consignees.

Discussion:

When your ingredients come in, you should already have checked to make sure they are correct and up to standard (by inspection, testing and/or supplier documentation).  Keep a log or binder with the information for each ingredient received.  I’ve found it easiest to keep a binder, and put the information for each ingredient received, with all the data about it on one page, and then place that in the binder.  The information should include the date ordered, invoice number, cost including shipping (from which you can calculate the cost per ounce or pound – however you use it), supplier batch/lot numbers, your assigned batch number if you have one, where it is stored, how it was inspected, etc. You could file them by date, by supplier and/or by type of ingredient.

For each batch of product you make, have a separate sheet with the recipe and procedures printed out and ready (I call mine a Batch Record sheet).  Assign a batch number to each batch (I use the date with a letter for each batch of the day – 20110601-A, 20110601-B, etc). As you make the product check off or fill in all the blanks for how much was used, who measured it (double check!), the batch/lot number of the ingredient (which will tie back to the ingredients/supplies documentation binder), what was done at each stage of the process.  Be sure to include any adjustments you had to make during the production process, if any.

If you have been keeping the cost of the ingredients accurately calculated, you will be able to calculate the exact cost of the batch, based on the actual ingredients you used in it.

When completed, test (either actual test or by inspection) and make a note of the results.  Take a small sample of the product from the batch, put that batch number on it, and store it safely (see #5 Production, and #6 Laboratory Controls in Part 2).

When you label the product, put the batch number the label for the product.  If you print your own labels, this is easy.  If you have labels already printed, make a space in the design so you can hand-write or print the batch number on each label before it is applied to the product.  Also attach a copy of the label to the Batch Record sheet.

Note that the Batch Number is not required on the label according to the labeling regulations, but it is considered to be part of Good Manufacturing Practices to have it on the label.  That way if any batch goes bad, you will know exactly which products were in that batch and can handle it more easily.

Finally, make a note of what was done with the product.  Was it for one customer?  Prepared to keep in stock to fill orders?  Whatever it was, write it down on the Batch Record sheet.

Keep the Batch Record sheets in a binder, in date order (or, if you prefer, keep sections for each type of product and keep the Batch Record sheets in date order by type of product).

Much of the information needed for both ingredients and on the Batch Record sheets can be kept in a computer file using MS Word or Excel, a text file or a specialized program.  You can also scan the paper documents (Batch Records with the production data handwritten, labels, MSDS and technical specs for ingredients and invoices) and keep them electronically.  BE SURE TO KEEP BACKUPS.  Having an offsite backup is good as well – just in case.

However, even if you have everything electronically, you should still have a paper record which can be easily referred to and contains the original data.

Bottom line, keep a record of everything – from beginning (receipt of ingredients) to end (final disposition of the product).

For the rest of the series, see:

• GMP Part 1, which covers Building and Facilities, Equipment and Personnel.
• GMP Part 2, which covers Raw Materials, Production and Laboratory Controls.

4. Raw Materials.

• Raw materials and primary packaging materials are stored and handled in a manner which prevents their mix-up, contamination with microorganisms or other chemicals, or decomposition from exposure to excessive heat, cold, sunlight or moisture.
• Containers of materials are closed, and bagged or boxed materials are stored off the floor.
• Containers of materials are labeled with respect to identity, lot identification and control status.
• Materials are sampled and tested or examined in conformance with procedures assuring the absence of contamination with filth, microorganisms or other extraneous substances to the extent necessary to prevent adulteration of finished products. Pay particular attention to materials of animal or vegetable origin and those used in the manufacture of cosmetics by cold processing methods with respect to contamination with filth or microorganisms.
• Materials not meeting acceptance specifications are properly identified and controlled to prevent their use in cosmetics.

Discussion:

When you get an ingredient in, correctly label and store all it so it doesn’t become contaminated. The container it came in may be sufficient, but if not, transfer it to an appropriate container that can be properly sealed. For small quantities of dry ingredients or oils, plastic containers with airtight seals work well; 5 gallon buckets are good for larger quantities. Essential and fragrance oils should be held in amber glass or metal bottles (not plastic).

Store all ingredients in the proper environment (temperature, humidity and out of direct sunlight) to ensure the product won’t go bad before you have a chance to use it. That means out of garages and attics that can get very hot or very cold; off patios and decks where they could be in direct sunlight (and get very hot).  I expect that most of you already do this, if for no other reason than to save money!

Keep all containers off the floor.  A low shelf or even boards to keep buckets off the floor will work.

Above all, LABEL EVERYTHING – not just with what it is, but the lot/batch/control number(s) from your supplier.  If you have the lot/batch/control number on the ingredient when it’s stored, you can tell exactly what goes into your product when you make it (important later on in GMP).  Also a good idea is to put the purchase date on the container, so you know exactly when you purchased it and can judge the appropriate shelf life if needed.  Take a small sample of the ingredient when you get it, put it in a container, label it (with all the same information as on the bulk of the ingredient being held) and store the sample safely.  That way you always have a reference sample to come back to  should you need it at any time in the future.

If you have the facility to do so, test ingredients when you get them.  If not, visually inspect the ingredient and make a note of what you see (good or bad).  Also review and check any MSDS and/or technical specification sheets provided by the supplier either with your order on from their website. Keep a copy in your files and connect it to the lot/batch number of your ingredient and also to the sample you kept aside.

If any ingredient arrives that doesn’t pass your inspection, label it as such (and also contact the supplier).  If you go to use an ingredient that has gone bad since you got it, clearly mark on it that it is not to be used in any product so it doesn’t get accidentally used.  If an ingredient does go bad before its time, you have your records and sample to address the matter with your supplier if necessary.

5. Production.

Check whether manufacturing and control have been established and written instructions, i.e., formulations, processing, transfer and filling instructions, in-process control methods etc., are being maintained. Determine whether such procedures require that:

• The equipment for processing, transfer and filling the utensils, and the containers for holding raw and bulk materials are clean, in good repair and in sanitary condition.
• Only approved materials are used.
• Samples are taken, as appropriate, during and/or after processing, transfer or filling for testing for adequacy of mixing or other forms of processing, absence of hazardous microorganisms or chemical contaminants, and compliance with any other acceptance specification.
• Weighing and measuring of raw materials is checked by a second person, and containers holding the materials are properly identified.
• Major equipment, transfer lines, containers and tanks are used for processing, filling or holding cosmetics are identified to indicate contents, batch designation, control status and other pertinent information.
• Labels are examined for identity before labeling operations to avoid mix-up.
  The equipment for processing, holding, transferring and filling of batch is labeled regarding identity, batch identification and control status.
• Packages of finished products bear permanent code marks.
• Returned cosmetics are examined for deterioration or contamination.

Discussion:

The production portion of GMP is primarily addressed to the procedures for large facilities with mechanized production and personnel performing specific tasks, but the fundamentals can, and should, be applied to small, handcrafted cosmetics manufacture.

First of all, make sure you have WRITTEN procedures and controls that cover all aspects of your production (both in general and for each individual product).

At the very least, you should have a written document for each different product you make that clearly states the formulation, the amounts needed for the batch size you are making, the exact procedures for making the product.  Even if only you make product and have done it so many times you could do it with your eyes closed, the documentation should be “stupid-proof” so that anyone which some degree of sense could pick it up, follow the directions and end up with a correctly measured, mixed, filled and labeled.  The directions should include:

• Making sure the equipment to be used is clean and sanitized;
• Checking to make sure the correct ingredients are used (not ones that have been labeled as bad);
• Double checking the weight/measurement of each ingredient (see note below)
• Taking sample(s) as needed;
• If you make several batches at once (i.e. a master batch that is then scented with different scents), the procedures you use to ensure they don’t get mixed up;
• Checking the labels for correctness (including batch numbers) before applying them to the product.

To comply with the “double weighing” requirement, consider weighing out your ingredients in advance (and, of course, correctly labeling each one), and then having another person (friend or family member, maybe) re-weigh them to double-check.  If you make the same product over and over, you could weigh out enough of each ingredient for several batches in advance, or do it when you have a second person available, and hold the containers of double-weighed ingredients until you are ready to use them.

6. Laboratory Controls.

• Raw materials, in-process samples and finished products are tested or examined to verify their identity and determine their compliance with specifications for physical and chemical properties, microbial contamination, and hazardous or other unwanted chemical contaminants.
• Reserve samples of approved lots or batches of raw materials and finished products are retained for the specified time period, are stored under conditions that protect them from contamination or deterioration, and are retested for continued compliance with established acceptance specifications.
• The water supply, particularly the water used as a cosmetic ingredient, is tested regularly for conformance with chemical-analytical and microbiological specifications.
• Fresh as well as retained samples of finished products are tested for adequacy of preservation against microbial contamination which may occur user reasonably foreseeable condition of storage and consumer use.

Discussion:

In an ideal world, we would all have the facilities to test water, incoming products, fresh samples and retained product samples, and working toward that idea is the best course of action.

However, in the meantime, you can check incoming raw materials in whatever way you can (visually, odor, etc) and require technical specification sheets from your supplier for the ingredients you purchase.  Keep aside samples of all incoming ingredients, correctly labeled.

Use water that either you test or that has been tested and bottled (i.e. bottled distilled water).  Do NOT use tap water – there may be unknown minerals. chemicals or micoroorganisms in it. Do NOT use spring or well water – it may be perfectly fine to drink, but could (and likely does) contain microorganisms or minterals that could damage your products.

Keep a sample of EVERY batch of product you make.  It doesn’t need to be a full-sized container – a few ounces will do.  But keep a sample of some size, properly label it (with the batch number and date) and set it aside.  If you can’t actually test your samples yet, then visually inspect to make sure they look good, and then check the held samples every so often to make sure they are stable and haven’t deteriorated.

For the rest of the series, see:

• GMP Part 1, which covers Buildings and Facilities, Equipment and Personnel.
• GMP Part 3, which covers Record keeping.

The Regulations

Cosmetics are sort of the bastard-child when it comes to GMP regulations. Both drugs and food have GMP standards set out in the regulations, but cosmetics do not. However, the FDA has published GMP Guidelines/Inspections Checklist for cosmetics. Originally it was an obscure document for inspectors, it is now easily accessible on the FDA website.

The FDA’s authority over cosmetics comes down to making sure that cosmetics for sale through interstate commerce are not adulterated or misbranded.  The FDA defines these as:

A cosmetic may be deemed adulterated for essentially four reasons, namely:

1. It may be injurious to users under conditions of customary use because it contains, or its container is composed of, a potentially harmful substance.
2. It contains filth.
3. It contains a non-permitted, or in some instances non-certified, color additive.
4. It is manufactured or held under insanitary conditions whereby it may have become injurious to users or contaminated with filth.

A cosmetic may be deemed misbranded for reasons of:

1. False or misleading labeling.
2. Failure to state prominently and conspicuously any information required by or under authority of this act.
3. Misleading container presentation or fill.

The FDA’s GMP Guidelines/Inspection Checklist covers all the points that could (or do) lead to a cosmetic being adulterated or misbranded.  Many are common sense and are easy to comply with for handcrafters making cosmetics in their home or a small shop (but might be of issue for large, commercial, factory-like facilities).

There are 10 areas of inspection.  I’ll cover the first few in this post and the rest in subsequent posts.

1. Building and Facilities.

• Buildings used in the manufacture or storage of cosmetics are of suitable size, design and construction to permit unobstructed placement of equipment, orderly storage of materials, sanitary operation, and proper cleaning and maintenance.
• Floors, walls and ceilings are constructed of smooth, easily cleanable surfaces and are kept clean and in good repair.
• Fixtures, ducts and pipes are installed in such a manner that drip or condensate does not contaminate cosmetic materials, utensils, cosmetic contact surfaces of equipment, or finished products in bulk.
• Lighting and ventilation are sufficient for the intended operation and comfort of personnel.
• Water supply, washing and toilet facilities, floor drainage and sewage system are adequate for sanitary operation and cleaning of facilities, equipment and utensils, as well as to satisfy employee needs and facilitate personal cleanliness.

Discussion:

Having appropriate facilities is relatively easy to comply with.  Most handcrafters are unlikely to work in an environment where there are pipes or condensation overhead and dripping into the mixing bowl!

2. Equipment.

• Equipment and utensils used in processing, holding, transferring and filling are of appropriate design, material and workmanship to prevent corrosion, buildup of material, or adulteration with lubricants, dirt or sanitizing agent.
• Utensils, transfer piping and cosmetic contact surfaces of equipment are well-maintained and clean and are sanitized at appropriate intervals.
• Cleaned and sanitized portable equipment and utensils are stored and located, and cosmetic contact surfaces of equipment are covered, in a manner that protects them from splash, dust or other contamination.

Discussion:

Using good and appropriate equipment that is easy to clean and maintain is also pretty common sense. No one making cosmetics in small batches is likely to have equipment that allows for dirt to build up and thus adulterate the cosmetics being made.

Of note, it is important that equipment and utensils be covered after being cleaned and stored, so they won’t become contaminated (dusty, dirty or splashed on, for example) before they are used again.  Surfaces should be kept clean, covered when not in use if possible (although it’s probably acceptable (and advisable) to clean/sanitize surfaces before use if they are not used and cleaned on a regular basis.

3. Personnel.

• The personnel supervising or performing the manufacture or control of cosmetics has the education, training and/or experience to perform the assigned functions.
• Persons coming into direct contact with cosmetic materials, finished products in bulk or cosmetic contact surfaces, to the extent necessary to prevent adulteration of cosmetic products, wear appropriate outer garments, gloves, hair restraints etc., and maintain adequate personal cleanliness.
• Consumption of food or drink, or use of tobacco is restricted to appropriately designated areas.

Discussion:

Well, you don’t want to have unqualified personnel making your product!  So make sure that you know what they are doing, and if you have someone making the product for you, make sure that they know what they are doing. Having documented procedures is helpful in ensuring that the people (including yourself) doing the work know what to do.  Written procedures also serve as a way of proving that the personnel have the training/experience to do the job.  Besides, it’s hard to remember every little procedure, especially if you are making several different types of products.

A lab coat, besides being cool and professional looking, is excellent for protecting against possible contamination (no cat hairs from your shirt falling into the lotion), and gloves and hair restraints are not just a good idea.  Remember also that for soapmaking, protective goggles are a must.

Lastly, have your snacks elsewhere and concentrate on the work at hand when making cosmetics.  Again, no chips or cracker crumbs in the bath bombs!

More to come

In upcoming posts, I’ll cover the next parts of the Good Manufacturing Practices Guidelines and Checklist.

For the rest of the series, see:

• GMP Part 2, which covers Raw Materials, Production and Laboratory Controls.
• GMP Part 3, which  covers Record keeping.

2010 Florida legislation

The pertinent Florida legislation that passed in 2010 appears to have been resulted in Florida Law Ch. 2010-161, which makes administrative changes to the way funds and authority are handled by various Florida agencies and departments.  It also included additional wording “prescription drug distributors”.  It does not appear that it effectively changed the existing regulations concerning soap and cosmetics.

It looks like the bill requires that the administration of cosmetic permits and enforcement will transfer from the Florida Dept of Health to the Department of Business and Professional Regulation effective October 1, 2011 (although neither of their websites obviously mention it).

Current Florida soap & cosmetic regulations

The current Florida regulations that cover soap and cosmetics are covered in Title XXXIII, Regulation of Trade, Commerce, Investments and Solicitations, and particularly, Chapter 499, Drug, Cosmetic and Household Products.

What the regulations cover

In addition to drugs and medical devices, the regulations cover cosmetics, which are defined as:

An article, with the exception of soap, that is:

(a) Intended to be rubbed, poured, sprinkled, or sprayed on; introduced into; or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance; or

(b) Intended for use as a component of any such article.

Note that it says “with the exception of soap“.  This is the same definition of cosmetic that is used by the FDA (although the FDA also includes the exact definition of soap).

So, using the FDA’s definition, a product that is

• a product in which the non-volatile portion consists principally of an alkali salt of fatty acids” AND
• makes no other claims than that it “cleanses” or “cleans”

is soap, and therefore exempt from the Florida cosmetic regulations.  However, if the soap in question makes cosmetic claims (beautifies, promotes attractiveness, etc), then is DOES fall under the cosmetic regulations.  (See my book, Soap and Cosmetic Labeling, pages 16 – 17 and Chapter 9 for more details.)

What qualifies as a “cosmetic manufacturer”?

According the the Florida statute, a “manufacturer” is defined as:

A person who prepares, derives, manufactures, or produces a cosmetic

To “repackage” is defined as:

Repacking or otherwise changing the container, wrapper, or labeling to further the distribution of the cosmetic

A “repackager” is a person who repackages.

Anyone meeting the definition of a manufacturer, which includes soapmakers who are making soap labeled as a cosmetic, and anyone who is a repackager is subject to the Florida regulations concerning cosmetics.

Also important to note that the definition of  “cosmetic” includes an article (ingredient) that is intended to be used in cosmetics. That means that the cosmetic regulations also apply to suppliers or vendors who sell ingredients intended for use in cosmetic products.

Permits required

A permit is required for each person and establishment that intends to operate as a cosmetic manufacturer or repackager in the State of Florida.  However, if the person only labels or changes the labeling of a cosmetic but does not open the container sealed by the manufacturer of the product, a permit is not required.

• The permit may only be issued to a natural person (not a business entity) who is at least 18 years old.
• An establishment that is a place of residence may not receive a permit and may not operate as a cosmetic manufacturer or repackager.
• A county or municipality may not issue an occupational license for a cosmetic manufacturer or repackager unless they already have a permit from the state.
• The current fee is a biennial fee (every two years) of $800.
• There is an additional fee of $150 for initial applications which require a site inspection (however there is no specification as to when a site inspection is required).
• There is a $100 fee to change the address on file on a permit, and the change must be filed prior to the actual change of address.
• The permit must be posted in a conspicuous place on the licenses premises.

When I checked several years ago, the actual forms were available online.  However, it appears they are being revised and must be requested from the Dept of Health.

Product registration

In addition to the manufacturer registration and permits, any person who manufactures, packages, repackages, labels, or relabels a drug or cosmetic in the state of Florida must register that product with the department.

Cosmetic labelers who are not required to be permitted as a manufacturer must still register their relabeled products. (So if your cosmetic is made by someone else for you and you label it, you still must register the product.)

• The fee to register a product is $20 per product for two years.
• The actual labels must accompany the registration form.
• Products that are identical except for name, size, color, or scent only require one registration. All subsequent identical products to that registration should be listed on an Identical Product Certification form.
• To add a product to an existing registration is $20 if more than 12 months remain on the original permit; $10 if less than 12 months remain.
• All product registration applications are to be sent to Tallahassee office for approval of certain labeling requirements.
• A product must be registered before any sales of the product occur.

The FL Dept of Health has the application form and instructions available online.  I did note, however, that both forms mention only drugs (and are dated 1999).  There may be more updated forms available.

Certificate of Free Sale

A “Certificate of Free Sale” is a document prepared by the Dept of Health which certifies a cosmetic is registered with the department and can be legally sold in the state.

There is fee of $25 to get the actual Certificate of Free Sale document (and $2 for additional copies ordered at the same time).  Up to 30 products may be listed on one Certificate of Free Sale.  You can also get a notarized copy for an additional $10.

It doesn’t look like having the actual Certificate of Free Sale is required, but the Dept of Health is asking distributors to request Certificates of Free Sale, so if you plan to Whole Foods or other similar companies, you may need to get one.

Inspections and Enforcement

What’s not mentioned much on the websites, but is included in the statues are all the rights given to the state to inspect and enforce.  When you register as a manufacturer, you explicitly give permission to the state to inspect, monitor and investigate (during business hours) to ensure you are following the regulations.

Of course, these are the same rights that the FDA has over ALL cosmetic manufacturers, so those who live in Florida shouldn’t think they’ve been singled out on the enforcement issues.

If violations are found, the State may issue a warning letter and will require you to fix any issues.  They have the right to stop the sale of any adulterated or misbranded products and to seize products if they feel it is warranted.  They can issue fines as well.  The guidelines for how they go about enforcing are somewhat vague, and are supposed to take into account the level of the violation, if there have been previous violations, what’s being done to resolve the issue(s) and other factors.  It seems to be up to the department at the time of the inspection.

What’s prohibited?

Well, the list of prohibited activity looks long, but it’s pretty much the same as the federal regulations. Note, I’ve only included items relating to cosmetics and have removed references to drugs and devices, to which all of these items also apply.

• The manufacture, repackaging, sale, delivery, or holding or offering for sale of any cosmetic that is adulterated or misbranded or has otherwise been rendered unfit for human or animal use;
• The adulteration or misbranding of any cosmetic;
• The sale, distribution, purchase, trade, holding, or offering of any cosmetic in violation of the Florida Statutes (Section 499);
• The dissemination of any false or misleading advertisement of a cosmetic;
• The refusal or constructive refusal:
  • To allow the department to enter or inspect an establishment in which drugs, devices, or cosmetics are manufactured, processed, repackaged, sold, brokered, or held;
  • To allow inspection of any record of that establishment;
  • To allow the department to enter and inspect any vehicle that is being used to transport cosmetics; or
  • To allow the department to take samples of any cosmetic.
• Providing the department with false or fraudulent records, or making false or fraudulent statements, regarding any matter within the provisions of the Florida Statutes (Section 499);
• Failure to obtain a permit or registration, or operating without a valid permit when a permit or registration is required by this part for that activity;
• The dissemination of any false advertisement of any cosmetic. An advertisement is false if it is false or misleading in any way;
• The manufacturing, repackaging, packaging, selling, delivery, holding, or offering for sale of any cosmetic for which the advertising or labeling is false or misleading;
• The advertising of any cosmetic that is adulterated or misbranded;

Adulterated and Misbranded

The key factors to any cosmetic being “illegal” falls to the definitions of “adulterated” and “misbranded”.  This is true in all the US as well as in Florida. Here are the actual definitions, as defined in the Florida Statutes.  These are almost exactly the same as the Federal definitions:

A cosmetic is adulterated:

(1) If it bears or contains any poisonous or deleterious substance that is injurious to users under the conditions of use prescribed in the labeling or advertisement thereof or under such conditions of use as are customary or usual; however, this subsection does not apply to coal-tar hair dye:

(a) The label of which bears the following legend conspicuously displayed thereon: “Caution: This product contains ingredients which may cause skin irritation on certain individuals, and a preliminary test according to accompanying directions should first be made. This product must not be used for dyeing the eyelashes or eyebrows; to do so may cause blindness”; and

(b) The labeling of which bears adequate directions for such preliminary testing.

(2) If it consists in whole or in part of any filthy, putrid, or decomposed substance.

(3) If it has been produced, prepared, packed, or held under conditions whereby it could have become contaminated with filth or whereby it could have been rendered injurious to health.

(4) If it is not a hair dye and it is, or it bears or contains, a color additive that is unsafe within the meaning of the federal act.

(5) For the purposes of subsections (1) and (4), the term “hair dye” does not include eyelash dyes or eyebrow dyes.

A cosmetic is misbranded:

(1) If its labeling is false or misleading in any particular.

(2) If in package form, it does not bear a label containing:

(a) The name and place of business of the manufacturer, packer, or distributor;

(b) An accurate statement of the quantity of the contents in terms of weight, measure, or numerical count; however, under this paragraph reasonable variations are permitted, and the department shall establish by rule exemptions for small packages; and

(c) A declaration of ingredients in descending order of predominance, or as otherwise required by federal law.

(3) If any word, statement, or other information required by or under authority of this part to appear on the label or labeling is not prominently placed thereon with such conspicuousness as compared with other words, statements, designs, or devices in the labeling, and in such terms, as to render the word, statement, or other information likely to be read and understood by an individual under customary conditions of purchase and use.

(4) If its container is so made, formed, or filled as to be misleading.

(5) If it is a color additive, its packaging and labeling are not in conformity with the packaging and labeling requirements applicable to that color additive prescribed under the federal act. This subsection does not apply to packages of color additives that, with respect to their use for cosmetics, are marketed and intended for use only in or on hair dyes.

What does it all mean?

Well, all of us, in Florida and elsewhere in the US, have the same bottom-line requirements of not manufacturing or selling cosmetics that are adulterated or misbranded.  That’s the fundamental concept underlying all Federal cosmetic regulations, as well as those in Florida.

Unfortunately, those who live and manufacture cosmetics in Florida have an additional burden of being required to get a permit for (and possibly initial inspections of) where they manufacture, and they can’t make cosmetics in a residence. Floridians also have to register each product (although the “identical product” provisions make that a little easier).

For soapmakers, if you are just making soap, you can avoid all the regulations by packaging and marketing your soap as “soap”.

So, I hope this helps shed some light on the Florida regulations and  dispells any myths about what is, and is not,  actually required.

My Half-Day seminar on Labeling was attended by about 20 people and I believe they all got a good overview and some hands-on experience reviewing and creating labels. All the information covered included in my book Soap and Cosmetic Labeling (except the many anecdotes I have collected over the years about labeling).

Which brings me to the point of this post — drug claims. Many people asked me about what constitutes a “drug claim” and asked me to look at the claims on their labels. Since I’ve come home, I’ve had a few more questions … so here is more information on how a cosmetic can become a drug.

A drug is defined by the FDA as:

Any product that is intended for use in the cure, mitigation, treatment, or prevention of disease and articles intended to affect the structure or any function of the body.

We all know that there are many ingredients that are beneficial to the body in some way or another; many have been used for centuries in “traditional” healing.  The fact that they haven’t been “approved by the FDA” doesn’t mean that they don’t work.  Many of us have even made creams, salves, butters and balms for personal use that were blended with essential oils or herbs to help with sore muscles, sprains, aches and pains.

However, to make the CLAIM that a product for sale will cure, mitigate or treat “disease” or affect the structure or function of the body (including relief of sore muscles, sprains, aches and pains) makes the product a drug (and subject to the FDA and all their many, many, many, many regulations.

Drug Claims

So, what constitutes a drug claim?  I went through some of the recent warning letters from the FDA and compiled the following list of examples of drug claims  from websites about products and/or product labels. (These are all topical products – not food or dietary supplements.)

• Loose your wrinkles!
• Vitamin C and E [ingredients in the product] help … protect skin cells from free radical damage
• (Testimonial) Ever since I started using [product] three weeks ago, I have noticed that the wrinkles on my forehead were less deep…\
• Rosehip seed oil [an ingredient in the product] contains Vitamin A, which helps to delay the effects of skin aging … and promotes collagen and elastin levels to increase.  This results in firmer … skin with greater elasticity
• According to the Centers for Disease Control, ‘In cell cultures, copper complexes cause some types of cancer cells to revert to non-cancerous growth patterns’
• Our formulation is pH balanced to maintain proper delivery of particles into the skin creating a…healing benefit
• Topical Vitamin C protects skin against harm caused by exposure to sunlight…
• Vitamin C has Anti-inflammatory benefits which reduce redness and irritation…
• Oxygen is a catalyst and energy source for most cellular functions.
• Oxygen is vital for all cells to sustain proper metabolism [product claiming to include oxygen]
• Oxygen has a significant role in wound healing, being essential to provide the additional energy source for the repair process. [product claiming to include oxygen]
• Oxygen is…component of the immune function…component of blood flow…functional element in hormonal mediators…required…during tissue repair process… [product claiming to include oxygen]
• Relief from: Cuts, burns, sunburns, abrasion, rash, diaper rash, bug bites, shaving, waxing and many types of skin irritations
• It is excellent for burns, sunburn, and rashes
• Stops the pain experienced with bikini waxing.
• (Testimonial) I had a stubborn outbreak of acne on my chin that persisted for 3 months…The acne seems to just be disappearing…
• Promotes…wound healing and skin conditions such as…eczema and psoriasis.
• Reduces redness
• Millions of men and women suffer the stinging embarrassment of chronic facial redness and flushing. . . . Now there’s [product]
• (Testimonial) After I tried [product], my face wasn’t lighting on fire anymore.
• [H]elps correct the effects of sun damage on the skin.
• Stimulates the renewal of skin cells
• Witch hazel [an ingredient in the product] : eases skin inflammation
• Employing the universal botanical soother Aloe vera, this formula provides healing support to worn out skin. Legendary for its ability to help the body recover from injury, Aloe actually promotes restoration of the skin, fostering strong ties between your inner skin fibers.
• Helps to calm, relax and promote restful sleep.
• Helps skin cells renew and repair themselves…
• Bruise Relief
• a patented formulation of essential plant oils proven to kill 99.99% of germs including MRSA, Salmonella, Staph, and E.coli
• [The] active ingredient is a proprietary, fast-acting, broad-spectrum antimicrobial created from a patented blend of natural thyme and other essential plant oils. . . . The heightened activity and novel combination of oils has proven highly effective at eliminating harmful transient bacteria, while leaving beneficial resident bacteria and soft, healthy skin
• Use: Sanitize hands when you can’t wash with soap and water

Claims about ingredients

You’ll note that in the above lists there are drug claims made about an ingredient in the product (even when the same claim is not made for the product itself).  That still constitutes a claim for the product.

Location of claims

Obviously, saying “for treatment of eczema” on the actual label on a container of cream would qualify as a drug claim.  What about saying that on the website that sells the product?  Yep, drug claim.  Having an article on the website by someone else that talks about the eczema-curing properties of an ingredient in the cream?  Yep, that’s a drug claim, too.  Putting out a press release on prwire about the healing properties?  Yep, drug claim.  (In fact, one of the warning letters I reviewed was the result of a claim made in a press release!)

Lipstick, lip gloss and lip balm

Lipstick and lip gloss are cosmetics.  They are applied to enhance or color the lips and are purely for increasing beauty and attractiveness (the definition of “cosmetic”).  Lip balms, however, are a different story.

Recently there has been discussion about whether the term “balm” can be used for a cosmetic product – especially a “lip balm”.  While I couldn’t find anything about the term “balm” by itself,  but “lip balm”is referenced in FDA regulations.

“Lip balm” (also called “lip protectant”) is considered drugs in the class of “skin protectants).  It can be a cream, gel, lotion or ointment.  The approved claims  are “helps prevent”,  “temporarily protects” or “helps relieve” “chapped or cracked lips”, and optionally, “helps prevent and protect from the drying effects of wind and cold weather”.  A lip product which contains sunscreen is also considered a drug under the sunscreen regulations.

In order for a lip balm to qualify as an over-the-counter skin protectant drug, the product must contain at least one of the following:

• Allantoin, 0.5 – 2 percent
• Coca butter, 50 – 100 percent
• Cod liver oil, 5 – 13.56 percent (with restrictions)
• Dimethicone, 1 – 30 percent
• Glycerin, 20 – 45 percent

However, it’s important to note that even though it would be easy to make a product that meets the ingredient requirements, the product must be labeled and manufactured as a drug.  The labeling part isn’t so hard, but qualifying as a drug manufacturer means being registered with the FDA as a drug manufacturer, having an inspected facility and qualifying with all Good Manufacturing Practices at the drug-level standard as specified in the regulations.  In other words, don’t try this at home!

Bottom line

The bottom line is that if you are making a cosmetic product, keep your label and all the accompanying materials (the “labeling”) on track.  Don’t make claims that the product will do ANYTHING other than “cleanse or promote beauty or attractiveness” … even if you know it will.  Be careful about testimonials on your site that make drug claims; even if they aren’t from you, they still count.

Do promote your ingredients; if your product contains arnica and your customer uses it for a sprain or bruise … so be it.  But don’t YOU tell them to do it!

It’s over 300 pages, and contains over 500 recipes for cold process soap, different types of cosmetics and scent blends. The recipes come from my extensive collection of antique and vintage soap and cosmetic books, dating back to the early 1700′s as well as research on more recent recipes.

I’ve always loved the historical approach to soap and cosmetics. After all, back in “olden times” all they had to work with were natural ingredients and essential oils. In act, many of these recipes served as the foundation for the products I make and sell through Chandler’s Soaps.

Of course, “natural” ingredients can include materials that are actually harmful, so I’ve selected only the recipes that include safe ingredients. We don’t want to make cosmetics with mercury, lead or arsnic (or opium, laudenum, or cocoain) all of which were common ingredients at times in the past!

Also included in the book you’ll find:

• an historical overview of cosmetics and soap
• general explanations of how to make each of the different types of products
• measurement conversion charts
• directions for increasing or decreasing batch size
• a glossary of ingredients (including alternative replacements)
• list of suppliers

The book is designed so you can either use the recipes as-is, or – because there are many recipes in each category – use the recipes as a starting point for developing your own unique formulation.

Update: June 15, 2011

Books are now available!  It is just $24.95, and includes FREE SHIPPING by media mail in the US.

To place your order, just click the “Buy Now” button. You’ll be taken to PayPal, where you can pay securely with your PayPal account or a credit card.