More interesting questions from readers this week. Smoothies in soap, trade secrets, essential oils, links to regulations and more. Please feel free to email me your questions to email@example.com!
If you make soap and use a smoothie (i.e. Green Machine or Bolthouse Farms Green Goodness) as water replacement, how would you label it? These products sometimes have about twenty items in them.
The answer depends on what you are doing with the soap and how you are marketing. If you aren’t SELLING the soap, then you don’t have to do anything. If you ARE selling, there are a couple of possibilities.
IF the soap is a “true soap” (essentially made with lye, water and oil) AND it is marketed as “soap” AND the only claim is that it cleans (no cosmetic claims), then an ingredient listing is not required.
IF the soap is marketed as something other than soap (as a body wash or facial bar, for example) OR there are any cosmetic claims for the soap (moisturizing, soothing, exfoliating, for example), then the soap is a COSMETIC and therefore requires the ingredients to be listed.
If you are using a blended ingredient in the cosmetic (such as a purchased smoothie) you must list the component ingredients of the blended ingredient in descending order of predominance based on their percentage whole formula.
This can be a bit tricky if you can’t get the actual percentages of the component ingredients from the manufacturer, especially when there are many components in the blended ingredient. Regardless, it’s still your responsibility as the manufacturer to know exactly what is in your cosmetic product and at what percentages, not only to be able to correctly list your ingredients, but also to ensure that the product is safe for your customers.
If you can’t get the information necessary to accurately determine the ingredients in your finished product and/or correctly label your product, you might want to reconsider your choice of ingredients.
I am a compounding pharmacist, and I want to repackage a scar gel as cosmetic product and sell in the market. What should I do?
As a compounding pharmacist, you are no doubt familiar with the regulations that apply to drugs (GMP, registration and approval, etc). Cosmetics – at least in the US – are completely different.
In the US, a cosmetic is defined as:
A product, except soap, intended to be applied to the human body for cleansing, beautifying, promoting attractiveness or altering the appearance.
As opposed to a drug, which is defined as:
A 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.
A “scar gel” would be a drug. If you are going to market the same formulation as a cosmetic, there cannot be any claims that the product would directly affect scars (altering the structure of the body). Only cosmetic claims could be made (to improve the appearance, make attractive or beautify).
With cosmetics, there is no registration or pre-approval required. You are responsible for ensuring that the product is safe, not adulterated, and not misbranded. Assuming you have the skills for ensuring the product is safe and not adulterated, then the only issue is the labeling.
The labeling requirements include having the name, product identity and net contents on the front of the package, and the ingredient declaration and name/address of the manufacturer (or responsible party) on an informational panel (back, bottom or sides). It’s pretty straightforward, and you can read up on the basics in my Quick Labeling FAQ.
With a “trade secret,” how do you disclose ingredients and meet labeling requirements, yet still keep it secret?
There are several ways to handle a trade secret.
The first is to file for a trade secret exemption from the FDA. There are forms to fill out and I believe you must disclose the full details, but they are supposed to be kept secret for you at the FDA. If you have trade secret exemption of some ingredients, you can put “and other ingredients” in the ingredient declaration.
Otherwise, you still have to put all the ingredients in the ingredient declaration. The ingredients at 1% or above must be listed in descending order of predominance, but you don’t need to disclose the exact percentage. Ingredients present at less than 1% can be listed in any order after the ingredients present at 1% or more. That might be enough to protect your trade secret.
Lastly, if what’s making your product unique is the scent, you could use the term “fragrance” in the ingredient declaration to encompass all the ingredients that make up the unique scent of the product. The components of a fragrance or flavor do not need to be disclosed or listed in the ingredient declaration (that’s how Coke can keep their formulation a secret without patents or trade secret exemptions – it’s just “flavor”).
Short of getting the FDA exemption and putting “and other ingredients” in your ingredient declaration, it still might be possible for someone to reverse engineer your product from the ingredient declaration and/or product testing. However, without the exact percentages of the ingredients and the components of the fragrance, they’d probably never get it exactly right.
I’d rather create a product that fits the “soap” definition (as opposed to the “cosmetic” or “drug” definition). Can I use essential oils without automatically implying a therapeutic benefit? Does scenting a soap cause it to be a cosmetic (as a perfume)?
Using essential oils in a “true soap” or a cosmetic doesn’t generally imply therapeutic benefit unless something is so stated on the label or in the labeling.
In cosmetics, essential oils are often used as the scent/perfume. Since the scent can be designated in the ingredient declaration as “fragrance”, when the individual essential oils are listed in the ingredient declaration or recognized them on the label (“made with pure essential oils” for example) is more marketing than anything else.
In “true soap” (not marketed as a cosmetic), inclusion of essential oils does not violate the soap exemption as it states (emphasis added):
A product in which the non-volatile portion consists principally of an alkali salt of fatty acids.
Fragrance compounds, including essential oils, are usually considered “volatile” (as opposed to “non-volatile”), so they don’t affect the exemption. Also, soaps have always been scented, so adding a scent shouldn’t make a difference.
Where are the original statutes online that specify the labeling requirements for soap?. According to the FDA’s website, these guidelines are under the Consumer Product Safety Commision, but I cannot locate any information on their site.
The FDA references the CPSC, which is, I think, responsible for ensuring consumer product SAFETY. The LABELING regulations under the Fair Trade Commission (FTC) come from the Fair Packaging and Labeling Act. The FTC has apparently revised their site … again. Their FPLA page is blank, but the text of the act can be found on the Legal Information Institute website.
The FTC does still have an overview of the FPLA and links to the actual labeling regulations enacted under the it.
Can you clarify what is required for plain soap (no cosmetic or medical claims) for private labeling.
Labeling of “true soap” (exempted from the FDA cosmetic regulations) is covered by the Fair Packaging and Labeling Act, and the regulations promulgated by the FTC to implement the FPLA. The links in the question above cover the actual regulations. The section that is applicable to your question is:
(a) The label of a consumer commodity shall specify conspicuously the name and place of business of the manufacturer, packer, or distributor. Where the consumer commodity is not manufactured by the person whose name appears on the label, the name shall be qualified by a phrase that reveals the connection such person has with such commodity; such as “Manufactured for ___,” “Distributed by ___,” or any other wording that expresses the facts. — 16 CFR 505.5(a)