Monday Mailbag – Patents, Sunscreen, Certification, Private Label and Hydrogenated OIls

mailbag

This is the first of my new blog post series, Monday Mailbag, in which I’ll answer soap or cosmetic labeling or GMP related questions that have been sent to me. We’re starting out with an eclectic mix this week – from patenting soap to how to list hydrogenated oils in the ingredient declaration.

If you have a question that you would like answered, please email it to me at hello AT mariegale.com. I hope to be able to answer 5 – 10 questions each week

I have a company that wants a private label. If they don’t want my name and address anywhere on the label, is that all right?

Your name and address doesn’t have to go on the label. Their name and address can go on the label with “manufactured for” or “distributed by” (to clarify that they aren’t the actual manufacturer). The full address (street, city, state, zip) is required, but if their business name is listed in a print city or phone directory, then the street address may be omitted (the city, state, and zip are still required).

I am a fairly new soapmaker and I recently made a batch of soap that friends seem to think is amazing – they have suggested that I patent it. Is that even possible?

I expect that it is possible to patent a soap. I’m not overly experienced in the area of patents, so I did a little research. This explanation of a patent is from http://www.gouldwhitley.com/index.php/patent-law

The term “patent” usually refers to what is technically a “utility patent”. It is also possible to apply for a “design patent”, which simply protects the aesthetic design of an existing useful article for fourteen years. An invention qualifies for a utility patent if it is a new and useful article, composition of matter, machine, or method, which is novel and not obvious to people skilled in the relevant area.

Of course, to patent it, you need to disclose enough of your formula and processes to uniquely identify it. Alternatively, you could treat the formula and process for your soap as a trade secret and just not let anyone know what it is. I know that Coke never patented their formula … they just keep it super-secret so no one can get and copy it.

I found a good article, When to Patent and Why that gives an overview on the pluses and minuses of patents. Besides all the legal ramifications, there is a substantial financial investment in the initial investigation for other applicable, patents, filing and enforcement.

If you really think there’s a good reason to patent your soap, check with a qualified attorney that specializes in intellectual property and patents.

I am wondering about labeling for sunscreen bars that I made yesterday. I will list the ingredients on the label, but I’m wondering, can I call them “sunscreen bars”. Is “sunscreen” a claim?

Sunscreen is most definitely regulated by the FDA as a drug. Any claim that the product is a sunscreen or has sunscreen properties – or makes the consumer THINK it is a sunscreen – would render the product a drug. There are extremely specific requirements for the manufacture, labeling and testing of any product that is claimed to be a sunscreen (not to mention the necessity of being registered and set up to manufacture drugs) — you probably don’t even want to attempt to go there.

There is another relevant issue when it comes to that – tanning products without sunscreen require a warning label. The FDA’s page Required Warning Statement for Tanning Products Without Sunscreen” explains what is required.

It’s like falling down a rabbit hole — even if your product contains sufficient zinc oxide to function as a sunscreen, it can’t be called a “sunscreen” because of the drug regulations. And since it it isn’t a “sunscreen” in the FDA/legal definition, then if you put anything on the label that implies that it should be used in the sun, you need to put the warning label on it.

I am looking into GMP certification for cosmetics and body care products. Do you offer certification or have a suggestion for how to achieve this?

In the US, cosmetic GMP is issued as “guidelines”. The FDA has a GMP checklist they use when inspecting and they have issued a new draft of their “current thinking” on cosmetic GMP. Also in existence are the ISO 22716 guidelines, which are the international standard all countries are working toward. You can purchase the ISO 22716 from the International Standards Organization for about $120 at the link above.

But, there is no governmental cosmetic GMP certification in the US. The only certification that exists for cosmetics in the US is through PRIVATE certifications. I found several international companies that do Cosmetic GMP certifications.

Europe is a different story. Since July 2013 the new EU Regulation 1223/2009 has been in force, which does require good manufacturing practices for cosmetics produced or sold in the EU. They also have additional requirements when it comes to selling cosmetics.

I have your cosmetic labeling book but still have occasional questions.

1) Is the term hydrogenated or partially hydrogenated required for cosmetic labeling? and 2) With regard to hydrogenated vegetable oil, is “vegetable” sufficient where a manufacturer or supplier refuse to answer what type of vegetable was used.

The requirements for how ingredients are identified on cosmetic ingredient labels are specified in the regulations. The first source is the Cosmetic Ingredient Dictionary, 2nd ed. (although the FDA does apparently recognize later editions) but for botanicals, the FDA wants the common name. That being said, I’ll address the second part of your question first.

I checked the CID 2nd ed for “Vegetable Oil” and found it listed in the CID defined as “An expressed oil of vegetable origin consisting primarily of triglycerides of fatty acids.” Of course, the CID also includes quite a few specific vegetable oils (coconut, palm, olive, etc). There is no clarification as to when the individual oil names should be used and when “vegetable oil” would be acceptable.

I also checked the Code of Federal Regulations; I didn’t see anything specific to cosmetic ingredients, but I did find this regarding food (21CFR101.4(b)(14)):

Each individual fat and/or oil ingredient of a food intended for human consumption shall be declared by its specific common or usual name (e.g., “beef fat”, “cottonseed oil”) in its order of predominance in the food except that blends of fats and/or oils may be designated in their order of predominance in the foods as “___ shortening” or “blend of ___ oils”, the blank to be filled in with the word “vegetable”, “animal”, “marine”…

In foods, however, the specific oils used in the vegetable oil must be listed in parenthesis following the statement “blend of ___ oils”. That’s different than what is stated in the CID, which implies that just “vegetable oil,” without specifying the individual oils, is acceptable for cosmetics.

That said, the FDA’s Cosmetic Labeling Guide gives a very specific example showing that blended ingredients must have the individual component ingredients listed in descending order of predominance within the whole.

Now to look at the first part of your question about using the term “hydrogenated” or “partially hydrogenated”. I checked the CID 2nd ed for “hydrogenated” and found a number of different hydrogenated oils listed, including “hydrogenated vegetable oil” (defined as “the end product of controlled hydrogenation of Vegetable Oil”).

I also checked the Code of Federal Regulations; that section quoted above goes on to say the following about hydrogenated oils:

If the fat or oil is completely hydrogenated, the name shall include the term hydrogenated, or if partially hydrogenated, the name shall include the term partially hydrogenated. If each fat and/or oil in a blend or the blend is completely hydrogenated, the term “hydrogenated” may precede the term(s) describing the blend, e.g., “hydrogenated vegetable oil[”].

So both the CID and the food ingredient regulations recognize a hydrogenated or partially hydrogenated oil as different from the oil in its native state.

So to answer your questions.

1) Based on the information in the CID and in the Federal Regulations for designation of ingredients for food, I believe that the term “hydrogenated” or “partially hydrogenated” should be used in the ingredient declaration to identify hydrogenated or partially hydrogenated oils used in cosmetic products.

2) Given that both the CID and the Federal Regulations for designation of ingredients for food recognize the term “vegetable oil” as a blend of vegetable-sourced oils, I believe that use of the term “vegetable oil” (or “hydrogenated vegetable oil,” if applicable) would be an acceptable way to identify an ingredient in a cosmetic product. HOWEVER, given that the FDA has otherwise stated that blended ingredients are not acceptable for cosmetic ingredient declarations, if there is any way to determine the component oils and identify then individually, that would probably be better.

Comments

  1. Regarding the “amazing” soap, you couldn’t get a utility patent without very particularly describing what is amazing about it. You’d need to test it for some measurable characteristic that people skilled in the art of soap making would understand from reading it. Does it do something useful, or some useful combination of things, that you wouldn’t expect soap to do?

    I could see only 4 reasons for pursuing a utility patent on the soap:

    (1) to license the formula to a big manufacturer;

    (2) you expect it to sell so well that it’d be worth other people’s while to reverse-engineer your formula, and that they would then get your customers;

    (3) to impress customers that it was unique enough that a patent examiner issued a patent on it;

    (4) to look impressive on your resume if you’re job hunting. (Slightly more impressive if you prosecute the patent pro se.)

    I got my foaming formula patented for reason #1 and partly #4, neither of which paid off. But then, most inventions don’t.

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