Personal Care Products Safety Act (2015)

laws-regsOn April 20th, 2015, Senators Diane Feinstein (D – CA) and Susan Collins (R – ME) introduced The Personal Care Products Safety Act (S. 1014), which, if passed, will update the Food, Drug and Cosmetic Act as it pertains to cosmetics.

There has been considerable discussion about various aspects of the bill and what its effects will be.  Several people have asked me for my take on the bill, so I’ve gone through the bill in detail . (What a process!) My comments about it and what it might mean are detailed below.

Please remember, these comments are my personal opinions and are based solely and only on my understanding of the existing laws and regulations and how this bill could, potentially, change those laws and regulations.

Additionally, since I am most familiar with the handcrafted soap and cosmetic industry my view is from that perspective.  Those who are in the “big business” realm of cosmetic manufacturing will probably have a different take on some aspects of the bill.

Chances of Success

First off, before getting worried and upset, it’s important to keep in mind how the legislative process works and what chances this bill has of making it through all the steps and becoming law.  Let’s take a look at some of the factors:

The process for the bill (somewhat simplified) is that it must get through committee (all previous similar bills failed at that point), then it has to get passed by the Senate, passed by the House and signed into law.  So there are a minimum of three points at which it is voted on and must pass by a majority vote. At each of those steps there is a possibility of amendment to the text.

The introducing Senator is a Democrat. Granted, she has some legislative history and political clout, but she is working in a Republican-controlled Senate. The bill will also have to make it through a Republican-controlled House.

There was only one co-sponsor (Republican Susan Collins from Maine) when the bill was introduced.  Since then two new co-sponsors have signed on; Barbara Boxer (D-CA) and Any Klobuchar (D-MN).  Previous bills had numerous sponsors, but they still failed.

Govtrack.us, which monitors all pending legislation, gives the bill only a 3% chance of passing.  You can track the bill here.

What the Bill Addresses

The intent of the bill is to “ensure the safety of cosmetics.”  To do so, it amends the Food, Drug and Cosmetic Act – mostly the cosmetic section, but bits and pieces elsewhere in the Act as well. The bill is similar to those that have been introduced in the past, with focus on registration, GMP, ingredient safety, adverse reactions and funding to the FDA.

Honestly, if I didn’t know anything about the handcrafted soap and cosmetic industry, I’d probably look at the bill and go, “Hey, that looks great.  Cosmetics should definitely be safe. The FDA should make sure that any dangerous ingredients are banned and know who is making what products.  If something is going to kill someone, then the FDA should be able to require the product is recalled.  Wait … couldn’t they do that before?”  (No, by the way).

So, since I DO know something about the handcrafted soap and cosmetic industry, I look at the bill and think, “I got into making soap and cosmetics because I wanted better, more natural, products to use. Putting all those regulations in place may be a way to get some control on what the big cosmetic companies are doing, but applying those same levels of control to handcrafters could be devastating.”

Some provisions have been made for small businesses, which would cover some (but not all) handcrafted soap and cosmetic businesses.  I believe many of these provisions are the result of the advocacy work of the Handcrafted Soap and Cosmetic GuildI agree with the HSCG’s stance that there are insufficient protections of small business as the bill is currently worded.

This bill applies to COSMETICS. It does not apply to soap that is exempt from the definition of a cosmetic. It also does not apply to candles or home fragrance products.

Breaking it Down

Now let’s break down what the bill covers and what it might mean. I’ve put the more applicable points first, even though they come later in the bill.

Keep in mind, once again, that the liklihood of the bill passing is slim.  Also, many of the provisions of the bill are fairly general and the FDA will have to put detailed regulations in place – and that process gives multiple opportunities for input and comment.

I apologize in advance for the length … at 98 pages, there is a lot of information in the bill!

1. Labeling Changes

There are a couple of labeling changes included in the bill; none of them are very substantial. They would go info effect 1 year after the bill is enacted.  There would probably also be additional FDA regulations created to cover the requirements in more details, which will take months or years to get into place (and I would have to update my Labeling book again).

a. Contact Information

The telephone number or electronic contact information (both are encouraged) would be required on the label.  That shouldn’t be an issue for most people. If there are privacy concerns, a separate phone number and/or email could be used.

Consumers should be able to report adverse events and get additional information about cosmetic ingredients. As a sort of odd inclusion (there must be some reason for it), the consumer must be able to ask if a specific ingredient is in the product that is not listed on the label (huh?) or if it is in a fragrance or flavor used in the cosmetic.  The manufacturer has to be able to get that information to the consumer and the supplier (of the flavor or fragrance) is required to release the information to the manufacturer.

b. Safety Labeling

Part of the bill includes the FDA review of ingredients and their determination of the ingredients’ safety (see #6 below).  In the event that an ingredient is determined to be unsafe for children, pregnant women or other vulnerable populations, the label must include an appropriate warning.

I assume that these warnings would be similar to the existing warnings that are required on cosmetics under some circumstances (e.g. the bubble bath warning and warning for tanning lotion without sunscreen).  For the most part, I hope that those making handcrafted cosmetics are not using ingredients that are determined, through real science, to be unsafe for children or pregnant women –  or anyone else for that matter.

c. Products for Professional Use

The bill includes special labeling for products for professional use and defines what qualifies for professional use.  Ingredient lists are required, and if the product contains an ingredient or a concentration of an ingredient that requires safe handling by trained professionals, the product would require a notice.

My guess is that this is for products like professional hair bleach or dyes or the stuff that was in the Brazillian Blow-out hair products that caused so much trouble.  I sincerely doubt that any handcrafter will produce products that fall into this category.

2. Internet Sales

The bill requires that an internet website offering cosmetic products for sale to consumers must provide the same information that is required on the label.  In other words, the identity of the product, the net contents, the ingredients and any required warnings, along with the directions for safe use and any other material facts.

This might be an issue for internet websites that are selling cosmetic products from multiple manufacturers, but I would assume that most people who are selling their own products already have most of this information on their website.  It’s good marketing!

There don’t appear to be any exemptions, so if the bill passes, the information will be required on all websites across the boards.

3. Facility Registration

Facilities that make cosmetics will need to register with the FDA.  The information will be public, excepting residential addresses will be kept private.

Businesses that make LESS than $100,000 in cosmetic sales annually are exempt. In my opinion, in order to protect the industry, this exemption should be higher. Sales over $100,000 may sound high, but it’s a DROP in the bucket of overall cosmetic sales. At that level a business making handcrafted cosmetics is just beginning to get into a new realm; added administrative and financial burdens could be devastating.

However, keep in mind that this is in cosmetic sales annually and does NOT include revenue from candles, household products or soap that is exempt from the definition of a cosmetic.

Over $100,000 in annual cosmetic sales, the facility must register, but there is no fee until the annual cosmetic income averages more than $500,000 for the previous three years, at which time the fee is $250.

Above that, there’s a gradient scale that goes from $500 when the cosmetic income is $2.5 million per year, to a fee of $1.1 million (yes, million) if the gross annual sales are $5 billion (yes, billion, with a “b”) or more.  Luckily, at that level, it’s definitely outside the realm of “handcrafted.”

4. Product Registration

Cosmetic products will need to be registered with the FDA. The product registration must include the ingredients, but the bill allows for a range of possible amounts of each ingredient, and a “list of fragrances, flavors and colors that may be included in the product ingerchangeably.”

I expect that the range of possible amounts is to keep exact cosmetic formulations secret, and it’s similar to the way it’s for patents and akin to how it’s handled in other countries, I think. The list of interchangeable fragrance, flavors and colors means that you could have a line of lotions that come in 20 different fragrances and/or colors, and you’d only have one product listing.  Of course, you’d have to determine in advance what those fragrances and colors would be.

Again, businesses that make LESS than $100,000 in cosmetic sales annually are exempt.

For small businesses, the bill allows that the FDA may create simplified ingredients statements for businesses that have to register their products, but have a 3-year average annual gross revenue in cosmetic sales of under $500,000.

5. Safety of Finished Cosmetic Products

Generally, each “responsible person” must make a written determination that the product is safe under the conditions of use recommended in the labeling of the product.  The determination of safety should be based on the safety of the individual ingredients in the product and of the finished product.

By the definition of “responsible person” in the bill, businesses that make LESS than $100,000 in cosmetic sales annually are exempt.

The FDA is required to issue guidance describing the evidence necessary to determine safety, and may establish exemptions to the requirements if they are supported by adequate evidence and would have no adverse effect on public health.

In addition, the FDA is required to issue more guidance for small businesses, which should include specific examples of options for compliance that don’t place an undue burden on small businesses.

If the bill passes, it remains to be seen what the FDA would consider as appropriate “evidence” of the safety of a cosmetic.  For those small businesses that make more than $100,000 in cosmetic revenue, but not much more, this part of the bill could be a problem. It really depends on how the FDA approaches the issue, how they assess the effect on public health, what they determine to be “adequate evidence,” what they consider “undue burden” on small business  and what exemptions they end up allowing in regulation.

The final regulations and guidances will take several years to get in place and there will be many opportunities to participate in the process.

Quite aside from the legislation and any regulations, if you are making cosmetic products you should at least have some idea that they are safe, and why.  If you haven’t already, you should honestly review your formulations, document them in detail and write out your view on why they are safe (your ingredients, preservative system, etc).  Collecting documentation on the safety of your ingredients – even if they are “generally regarded as safe” food items – is also a good idea (and part of good manufacturing practices).

6. Preemption

Preemption: A doctrine based on the Supremacy Clause of the U.S. Constitution that holds that certain matters are of such a national, as opposed to local, character that federal laws preempt or take precedence over state laws. As such, a state may not pass a law inconsistent with the federal law.1

The bill includes a provision for preemption, applied to registration, good manufacturing practices (see #7 below), adverse event reporting (see #9 below) and recalls (see #10 below). In other words, it says that the states can’t create laws or regulations that are different from the federal laws. There are a few exceptions, as in the case where there is already an existing and implemented law in place.

I’m not sure how the various states will react to this.  Maybe they’ll think it’s a good thing and they won’t have to worry about all the different aspects of registration, GMP, recalls and adverse event reporting; maybe they won’t like the fact that the federal government is telling them what to do.

In any event, it would make things easier all around, especially since some of the states are considering their own registration processes.

7. Good Manufacturing Practices for Cosmetics

If this bill is passed, the FDA is to propose regulations for good manufacturing practices for cosmetics.  The Cosmetic GMP regulations are to be in accordance with national and international standards “as the FDA determines practicable and appropriate.”  The FDA has 18 months to issue a proposed rule, and 3 years to issue final rules; rules will take effect for small businesses 2 years after that.

Good Manufacturing Practices bookThe international standards for good manufacturing practices are issued in ISO 22716 Standard, “Good Manufacturing Practices for Cosmetic Manufacturing” (available for about $125 from the International Standards Organization).

My book, Good Manufacturing Practices for Soap and Cosmetic Handcrafters, covers ways in which handcrafters can adapt the basics of GMP to their operations.

There don’t appear to be any exemptions for small businesses in this section other than to allow 2 years before the regulations take effect for small business while big businesses only have 180 days.

In my opinion, if the bill passes (again, unlikely), ensuring that the FDA understands the handcrafted industry and takes our needs into account when promulgating GMP regulations will become extremely important.

8. Review of Ingredients

As part of the bill, the FDA is required to review cosmetic ingredients and “non-functional constituents” to determine their safety in cosmetics.  The bill includes a number of provisions about how the review is supposed to take place and establishes a Cosmetic Safety Advisory Committee with members from the industry, consumer groups and other individuals, to advise the FDA on what ingredients should be reviewed and do other things.

The first ingredients to be reviewed are diazolidinyl urea, lead acetate, methylene glycol/methandeiol formaldehyde, propyl paraben, and quaternium-15.  I expect those ingredients were picked because they are the focus of public scrutiny and have been (or are being) regulated in other countries. After that, the FDA is supposed to review 5 ingredients or non-functional constituents per year. They are allowed several years for each ingredient to go through the review process.

This portion of the bill shouldn’t have any effect on cosmetic handcrafters.  It the long run it will be some additional information to keep track of and, for some people, could result in reformulating if an ingredient is determined to be unsafe.  But, if that’s the case, you probably want to reformulate anyway!

9. Adverse Event Reports

Most people don’t realize that cosmetic manufactures are not REQUIRED to report adverse reactions to their products.  The FDA requests that they do so, and has a campaign to get the public to report problems, but none of it is required.

The bill requires that cosmetic manufacturers report any “severe adverse event” for a cosmetic product.  A severe adverse event is one that results in death, a life-threatening experience, inpatient hospitalization, persistent or significant disability or incapacity, congenital anomaly or birth defect, or significant disfugurement.  (Yikes!) It goes into detail on how reports are submitted and what should be done with them by both the manufacturer and the FDA.

Technically, businesses that make LESS than $100,000 in cosmetic sales annually are exempt. However, in my opinion, if you make a cosmetic product – regardless of your annual sales – that results in the hospitalization, disfigurement, or death of a customer, not only should you report it, you should seriously consider a different line of work.

10. Mandatory Recall Authority

Another thing that many people don’t realize is that the FDA has no authority to order a cosmetic company to recall their products.  The product could be harming customers, but all the FDA can do is warn the manufacturer about the issue, request they voluntarily recall the product, issue a public warning as a Consumer Alert, or seize the product (where they can).

This bill, if passed, give the FDA mandatory recall authority.  In other words, after they’ve given the manufacturer the opportunity to recall a product that is likely to cause serious adverse health consequences or death and nothing is done about it, the FDA can require them to recall the product. The bill lays out the steps for hearings, notices and orders.

Again, businesses that make LESS than $100,000 in cosmetic sales annually are exempt. In my opinion, I think the FDA should have the authority to order the  mandatory recall of a dangerous cosmetic product.

11. Animal Testing

Lastly, the bill addresses the issue of animal testing by encouraging manufacturers to reduce or eliminate animal testing and requiring the FDA to provide information on other adequate testing options.

My Opinion in Summary

First of all, I wish that this were two different bills – one having to do with the safety of ingredients, adverse reaction reporting and mandatory recalls (which I support), and the other covering everything else (which I generally don’t, at least not without higher exemptions for small business). But, sadly, that’s not the case.

As it is, I feel that even with the relatively decent aspects of the bill, the fact of the low exemption levels for handcrafters means that it could potentially do more harm than good to our industry.

Worst Case Scenario

As I see it, the worst case scenario is that the bill is passed as-is, without higher exemption caps for small businesses.

Less Than $100,00 Annual Cosmetic Revenue

Businesses that gross less than $100,000 in annual cosmetic revenue and intend to stay below that income level will be the least effected. They will still have the costs of changing labeling and updating their websites.  The most unpredictable factor is how the FDA deals with the regulatory implementation of GMP.  If the FDA exempts this size business it will not be an issue, but if compliance with full-on GMP regulations is required, it could be devastating to this group of handcrafters.

Between $100,00 to $2 million Annual Cosmetic Revenue

The group who will be most affected will be those who make over $100,000 and less $2 million in cosmetic revenue per year. There are numerous small, small businesses (many still working out of their homes) that fall into this category, particularly those in high density, high cost-of-living urban areas or that have very successful websites. It only takes selling 200 lotions at $20 each, 500 soaps at $7.50 each and 200 bath bombs at $4.00 each per month to make over $100,000 in annual revenue.

That may sound like a lot to some people, but when a business reaches that level it is still very small and probably very fragile.  It is the most difficult time for a business – when it is JUST getting to the point of some “decent”  profit, but is still struggling with maintaining production, meeting demands, providing for capital improvements, getting new facilities, adding and training staff and all those things that go into the “transitional” stage of a business.

At this stage, it doesn’t take much to collapse a business; a huge wholesale order gone bad or the burden of  additional regulatory costs and administration could do it.

Discouraging Growth

Probably one of the worst results of the bill, in the unlikely event that it is passes as-is, is that it would discourage growth in the handcrafted soap and cosmetic  industry.

Best Case Scenario

The provisions in the bill to ensure consumer safety stay intact (serious adverse event reporting, FDA ingredient reviews, mandatory recalls), and the exemptions for small business are sufficiently increased to reduce the burden on small and emerging handcrafted businesses, particularly those that have “made it” and are in that delicate transition stage.

I’m rooting for the HSCG and their legislative advocacy efforts to carry the message to Washington and get the exemptions suitably increased. So far their actions have served the industry well.

If you’re not a member, I urge you to consider joining the HSCG.  Making headway in Washington takes not only time and a deep understanding of the industry, it takes money to cover the expenses of going there and having meetings, providing materials and paying for an advocate to watch our collective back — and the only source of funds for those activities comes from membership dues.  Plus, the larger the group, the stronger the voice.

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Comments

  1. It’s great to have this explanation of the fine points of this bill. I feel much better knowing your expert opinion. I need a little clarification, though, on the math of the paragraph titled “Between $100,00 to $2 million Annual Cosmetic Revenue”. Your math includes soap, which I thought you made clear was not a cosmetic. Would the sales for soap be included in total annual revenue if I were so lucky as to fall into this group?

    1. Author

      I included soap in the calculations because most people who make cosmetics and also make soap tend to make soap that falls into the definition of a cosmetic (there are cosmetic claims for the soap, for example).

      Soap that is truely exempt from the definition of a cosmetic – that is, it is a “true soap” (the alkali salt of fatty acids) AND it is only marketed as “soap” AND it only claims to clean – isn’t covered by the proposed bill. So a company that ONLY makes soap that is exempt from the cosmetic defintion wouldn’t be subject to the bill.

      However, someone who makes true soap AND cosmetics would still be subject to the bill as far as registration of the facility, and the cosmetic products would be subject to all the other axpects of the bill.

      1. Is ‘melt n pour’ considered soap? Do candles fall in this category?

      2. Author

        If melt and pour soap is NOT made with lye, water and oils (in other words, not a “true” soap), then it is a cosmetic and manufacturers who use it would be making cosmetic products. If the MP soap IS a “true soap”, then it depends on whether there are any cosmetic claims made for it (moisturizing, soothing, etc). If so, then it is a cosmetic. If not, AND it is marketed only as “soap” AND the only claim is that it cleans, then it is exempt from the definition of a cosmetic and the cosmetic regulations don’t apply.

        Candles are not cosmetics, so candlemakers will not be affected by the bill (unless they also make cosmetics).

  2. As always you have delivered a fantastic presentation of the ups and downs, the pros & the cons in a really well done objective breakdown. Thanks! You really helped me see it more clearly and I will be sharing it widely with those soap artists I have on my art show circuit. And yes…your wish that it could be broken down into two pieces of legislation and that the $100K point is low (and yes, I a first reacted with a “huh?!?!” until you showed so smoothly the very few products on monthly basis that would take someone to and over that level). Thanks for sharing & allowing me to be far more educated in this arena!
    Debi

  3. Thank you for explaining this bill and just how it will effect us soap makers. I am reposting this on fb.

  4. This is a very good break down of this bill. Thank you for your expertise! I would also like to say though that while I don’t think people should panic when new legislation is brought up we also shouldn’t sit idly by hoping it won’t pass. Many of the bills that have low chances of passing are that way because people let their voice be heard. A lot of laws are passed when no one makes a fuss about it because they figure it won’t pass anyway. We shouldn’t make it easy for them to slip it through because just like you said, if you had no idea about making handmade soap and cosmetics you would think all of this was a great idea. So, I’m sure there are plenty of congressmen who might get the same idea too just because we sat silent. Okay, off my soap box. Thanks again for the great read.

    1. Author

      I agree that it’s not a good idea to just site idly by and hope things will turn out okay. On the other hand, when dealing with legislation, it’s often a matter of timing. While the bill is in committee it’s not likely to be heavily on the radar of uninvolved Senators.

      Personally, I will be writing my Senators, but I want to wait and watch the information from HSCG and their advocate in order to time my communications so they have (I hope) the biggest possible impact.

  5. Thank you, as always, for taking the rats nest of legislation and presenting it to us in a level-headed, fair minded, clear point of view. The sneaky timing of its announcement, right after the annual HSCG conference, I think added to the uproar considering how many other “laws” have secretly passed behind closed doors when announced in this manner. I feel much better after reading your summation. I will continue to support the HSCG and others fighting to protect our small businesses while also protecting the consumer. No one wants the “bad manufacturer”, of any size, to get away with making dangerous products but overzealous legislation is not the answer. Thank you again for clearing this up and helping many of us take a sigh of relief but recognize we must still be the best we can, do the best we can, follow the current regulations and keep a wary eye on future ones. 🙂

  6. Marie, there’s a soaper who claims “The only exemptions for small business are in section one of the bill which is about yearly fees and registrations….The other sections do not exempt small business” – can you advise your thoughts?

    1. Author

      That’s partly true – there are some sections that do not exempt small business; but most do.

      In the Definitions Section of the proposal, a “Facility” is defined as a place that manufactures, processes, packs or holds cosmetics with 8 (A-H) EXCEPTIONS including “(G) domestic manufacturers with less than $100,000 in gross annual sales of cosmetic products.”

      Also in the Definitions Section, a “Responsible Person” has two definitions, the first of which is “(A) the brand ownder who is the domestic or foreign manufcturer … whose name appears on a cosmetic product label … except for entities described in subparagraphs A-H of paragraph 3” (which are the A-H exceptions from the definition of a “Facility”).

      So, from the definitions we see that small businesses with less than $100,000 in annual cosmetic sales are exempted from both the definition of a “facility” and the definition of a “responsible person”. Using that, you can see which sections exempt small business:

      • Registration of facilities applies to “facilities” so small businesses are EXEMPT.
      • Cosmetic ingredient statements are required by the “responsible person” so small businesses are EXEMPT.
      • Determination of the safety of finished products (as defined in the proposed bill) is assigned to the “responsible person” so small businesses are EXEMPT. [Although that doesn’t negatee the general responsibility for product safety for ANYONE who manufactures cosmetics which exists now.]
      • Good manufacturing practices regulations (to be written by the FDA) apply to all cosmetics according to the bill. Small business MAY be fully or partially exempt from the regulations, depending on what is finally written by the FDA.
      • Adverse event reporting for cosmetics requires the “responsible party” to submit reports to the FDA, so small business is EXEMPT. [Although if someone has a serious adverse reaction (hospitalization, permanent disability or disfigurement, or death)to a product from a small business, it should probably be reported anyway.]
      • Inspection of Cosmetic Records appears to apply to all who manufacture, process, pack or hold cosmetics, so small busienss are NOT EXEMPT.
      • Mandatory recall authority to the FDA would give them the authority to recall products by small businesses.
        Changes in the labeling requirements for products for professional use, internet sales and contact information would apply to all, small businesses NOT EXEMPT.

      Under the bill, the FDA is required to review cosmetic ingredients for their safety and small busiensses would, of course, still be subject the the FDA’s final determinations of the safety of cosmetic ingredients.

      —————————-

      Okay, that all said, please realize that this is MY INTERPRETATION of the bill and who the different parts would apply to, based on my understanding of the way the bill is structured and the English language. There may be other factors (past legal findings, court opinions, etc) that affect how it is interpreted in the final application.

      1. Thank you, Marie, and your caveat is noted 🙂

  7. Thank you for your clear explanation of this bill and the potential impacts to all of us. I have been following the requests of HSCG and emailing the people responsible for this bill, asking them to withdraw it and/or re-write it. I have also written to Lamar Alexander and Patty Murray the Chairman and Ranking Member of the Senate Health, Education, Labor and Pensions (HELP) Committee asking them to kill the bill and/or send it back for a re-write.

    The bill, if passed will only mildly inconvenience the large commercial manufacturers who have the resources to comply with new regulations and it would seem that many of them are in fact supporting the bill. Johnson & Johnson, Procter & Gamble just to name two. This leads me to believe that the real intent is to undermine the smaller soap and cosmetic maker. This bill will only increase their monopoly and allow them to capture more of the “natural” products market. I said as much to Feinstein, Collins, Boxer and Klobuchar.

    1. Author

      No, nothing has passed. It has gotten a couple more sponsors, but is still currently in committee (which is where most bills die).

      It still has to get out of committee, be passed by the Senate, be passed by the House and signed by the President – all by the end of ther 114th Congress (January 2, 2017).

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