Compliance Corner: Labeling Your Products
By Steven Borden, Compliance Officer
Compliance and Your Product’s Label
There are many important factors to consider when composing labels for your product, among the most critical being, the claims you intend to make. One always has to be able to offer substantiation for one’s claims and government agencies such as the FDA can be very particular about what claims can and can’t be made. Perhaps the most significant claims related issue is the distinction between cosmetics and drugs.
The Difference Between Cosmetics and Drugs
The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines cosmetics by their intended use, as
… articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance [FD&C Act, sec. 201(i)].
Every claim you consider making in the marketing of your cosmetic product must remain within these boundaries. If your product’s labeling suggests it does anything more than cleansing, beautifying, promoting attractiveness, or altering the appearance, it is exceedingly likely that you are making a claim that will cause your product to be classified by the FDA as an unapproved drug.
The FD&C Act defines drugs, in part, by their intended use, as
…articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals [FD&C Act, sec. 201(g)(1)].
If your product’s labeling suggests the product “cures,” “mitigates,” “treats” or “prevents” anything, it is likely that you are making a drug claim. Note that common problems such as acne, dermatitis, eczema, psoriasis, dandruff, bacterial, viral, fungal and parasitic infections, allergies, depression, anxiety, baldness, obesity, hyperactivity, insomnia, disordered memory, inflammation, pain, etc. are all technically diseases or symptoms of diseases. Any cosmetic product marketed to cure, mitigate, treat or prevent any of these, or any other diseases or symptoms of disease, is likely to be classified by the FDA as an unapproved drug and the FDA will require you to remove any drug claims from your labeling.
Understanding Intended to Affect
What is meant by “intended to affect the structure of the body” and how does that differ from the action of a cosmetic? Remember that a cosmetic cleanses, beautifies, promotes attractiveness, or alters the appearance. A cosmetic only affects the way we look. So a product that claims to promote “radiant skin with a youthful appearance” is a cosmetic. However, a product that claims to “eliminate fine lines, wrinkles and sagging”, thereby affecting the structure of the skin, is a drug. A beautifying crème is a cosmetic. An anti-aging crème is a drug, and anti-aging, anti-wrinkle, or anti-sagging claims are likely to cause your cosmetic to be classified by the FDA as an unapproved drug.
What is meant by “intended to affect any function of the body”? The sebaceous glands in our skin produce oil (sebum), and when we become dehydrated sebum production slows, which may cause our skin to stiffen and crack, but sebum production is not a function of the skin itself, and dry skin is not considered a disease or necessarily a symptom of disease. Therefore, a product such as a lotion that adds moisture for the purpose of lubricating the skin is a cosmetic, not a drug. On the other hand, a product that was intended to stimulate the sebaceous glands to produce oil, thereby affecting the bodily function of dermal lubrication, would be a drug. And the sebaceous glands are not the only moisture producing structures in the body.
The eyes contain nasolacrimal ducts, sometimes called tear ducts, which produce ocular lubrication. The vagina contains bartholin’s glands that produce lubrication to facilitate sexual intercourse. The production of moisture is a vital function to both of these organs and any product marketed to stimulate or add to either ocular or vaginal lubrication is purporting to affect these bodily functions and would therefore be classified as drugs, not cosmetics. So, a lotion or crème applied to moisturize the skin is a cosmetic and a personal lubricant used to add moisture to the vagina is a drug.
Including “Intended Use” on Your Label
We referenced “intended use” in the marketing of both cosmetics and drugs. What does this mean? Intended use may be established in a number of ways. The following are some examples:
- Claims stated on the product labeling, in advertising, on the Internet, or in other promotional materials. Certain claims may cause a product to be considered a drug, even if the product is marketed as if it were a cosmetic. Such claims establish the product as a drug because the intended use is to treat or prevent disease or otherwise affect the structure or functions of the human body. Some examples are claims that products will restore hair growth, reduce cellulite, treat varicose veins, increase or decrease the production of melanin (pigment) in the skin or regenerate cells.
- Consumer perception, which may be established through the product’s reputation. This means asking why the consumer is buying it and what the consumer expects it to do.
- Ingredients that cause a product to be considered a drug because they have a well-known (to the public and industry) therapeutic use. An example is fluoride in toothpaste.
How the FDA Classifies OTC Products
Under the FD&C Act, cosmetic products, and ingredients, in general, do not require FDA approval before they go on the market. Drugs, however, must generally either receive premarket approval by FDA through the New Drug Application (NDA) process, or conform to a “monograph” for a particular drug category, as established by FDA’s Over-the-Counter (OTC) Drug Review. These monographs specify conditions whereby OTC drug ingredients are generally recognized as safe and effective, and not misbranded.
The world of natural products is filled with wondrous ingredients many of which may be equal or superior to those synthetic drugs making up the bulk of modern pharmacology. Nevertheless, at this time, the FDA does not recognize the efficacy of most of them and, therefore, will not allow vendors to make any drug claims about them.
For example, the FDA has published a monograph, available online, for topical acne products. The monograph details exactly which chemicals at precisely what concentrations effectively treat acne to the FDA’s satisfaction. If you wish to market an acne treatment, it must be manufactured in strict accord with the FDA monograph using their approved ingredients at their predetermined proportions. Any deviation will cause the FDA to classify your product as an unapproved drug. Note, the FDA does not recognize lavender oil, for example, as an anti-acne agent. It doesn’t matter how many hundreds, or thousands, of peer-reviewed clinical trials, demonstrate the efficacy of lavender oil in the treatment of acne. Lavender oil is not included in the FDA’s monograph for topical acne products. Should you choose to market a coconut oil-based lotion with 3% lavender oil as an “acne treatment” the FDA will classify the product as a misbranded unapproved drug; Lavender Lotion is a cosmetic, not a drug, and it can only be marketed as a cosmetic.
Putting it All Together: Labeling and Marketing
The information you include in your label must adhere to FDA regulations. So, too, does your marketing. When you promote your product online or at a festival, or using a Point of Sale promotion in a retail store or spa, you’ll want to observe the same guidelines as you would for your label. In other words, be careful what you claim.
As always if you have any questions or comments, please let us know. We appreciate your interest and invite you to share this article if it was helpful to you.