Cosmeceuticals: the Good, the Bad and the Ugly
19 May, 2015 MasterControl
Since retiring from FDA, I have assisted numerous businesses in developing labels for “Cosmeceuticals.” I have also presented a number of training programs on the manufacturing and marketing of such products. When I was asked to write something using this specific title, I thought I would be able to quickly put an article together. At first, I had a difficult time putting pen to paper because I couldn’t think of anything “ugly” about cosmeceuticals as I define them. To get started I searched the Internet to see what others were saying about these products.
I finally concluded that the ugliest thing about cosmeceuticals is the disparate and sometimes incorrect way they are being defined by various parties. The first five hits in my search included statements by Wikipedia, an independent business, a dermatology group, a private drug information source and the FDA. Wikipedia was the first hit and, among other things, said:
|What is a cosmeceutical? Is it a
lotion, a shampoo, shaving cream?
Or is it something else?
“Cosmeceuticals refers to the combination of cosmetics and pharmaceuticals” and, “The term "cosmeceutical" is often used in cosmetic advertising and may be misleading to the consumer. If the consumer interprets a cosmeceutical to be similar to a pharmaceutical product, he or she may conclude that cosmeceuticals are required to undergo the same testing for efficacy and quality control as required for medication.”
The FDA page that came up (1), last updated in March 2014, stated:
“While the Federal Food, Drug, and Cosmetic Act (FD&C Act) does not recognize the term "cosmeceutical," the cosmetic industry uses this word to refer to cosmetic products that have medicinal or drug-like benefits. (…) While drugs are subject to a review and approval process by FDA, cosmetics are not approved by FDA prior to sale. If a product has drug properties, it must be approved as a drug.”
I take exception to both of those statements, because the cosmetic industry is not alone in using the term and it is indeed possible for companies to legally market certain combinations without the same pre-approval that would be applied to a new generic drug or a new molecular entity. The underlying issue here is whether OTC drug ingredients that are formulated and labeled in compliance with an FDA OTC Drug Monograph should be deemed FDA “approved” and the answer is of course they should. To explore this issue further the reader should become familiar with the FDA’s OTC Drug review process.
While it is true that FDA has never formally recognized the term “cosmeceutical,” the above quote from the FDA’s Information piece is overly simplistic and otherwise misleading because a product may indeed, as the Wikipedia definition suggested, contain both OTC drug ingredients recognized by FDA as safe and effective and ingredients recognized by the agency as safe and suitable cosmetics (2). Formulating a legitimate cosmeceutical is not really that difficult when one considers that all of the nineteen ingredients listed in FDA’s Skin Protectant OTC Drug Monograph (21 CFR Part 347) are also recognized safe and suitable cosmetic ingredients. Other monographs that provide opportunities for formulating cosmeceuticals include those for topical antimicrobials, sunscreens, anticaries drug products and oral healthcare products.
Some of the statements one finds on the Internet seem to support the notion that cosmeceuticals are simply cosmetics for which unwarranted drug claims are made and that they are inherently misbranded or new drugs without FDA approval. The FDA Information Piece I view as misleading provides a link (3) to a different FDA document “Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?).” That document, updated in April 2014, is not as simplistic and conveys a great deal more information about the composition of perfectly legal cosmeceutical products. It discusses, among other things, the definitions of “drug” and “cosmetic” which are essential for understanding this topic. My unofficial, abbreviated definition for a cosmetic product is one intended to “cleanse, beautify or promote attractiveness,” whereas a drug product is one “intended to treat or prevent disease or otherwise affect the structure or function of the human body.” One only has to take a quick look at a fluoride toothpaste label and take note of the cleaning/whitening cosmetic claims and the prevent dental cavities claim to see compatible cosmeceutical claims.
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So what exactly is a “cosmeceutical?” Is it….
1. A cosmetic formulation of no proven medicinal value that is represented in advertising and/or labeling statements by its marketers for treatment of a physiological disease or condition of the body.
Or, is it…
2. A product formulated with ingredients generally recognized by scientists as having properties that are both physiological (drug) and physical (cosmetic), and labeled in accordance with applicable regulations.In my opinion, the latter definition, which I use in my consulting and presentations (4) on this subject, best represents what a cosmeceutical is. Indeed, definition number one, in my opinion, defines a “health fraud.” FDA has referred to cosmeceuticals in its publications for many years as “cosmetics that are also drugs” or equivalent language. It has always been a mystery to me why FDA has avoided using the dreaded term “cosmeceutical” when the agency could have defined the term so that it would be less likely to be used in the promotion of health frauds by unscrupulous marketers.
Certainly the negative (or bad) connotations of the term cosmeceutical stems from years of promotional efforts by many marketers to make cosmetics appear of greater value than they really are. If one can get away with puffed up claims that imply or directly provide a medicinal use for a cosmetic, more than likely it will sell better than a competing product that has essentially the same formula without such claims. Companies sometimes find themselves in claims “horsepower” races and they sometimes become outrageous. Such misbranding with unwarranted and unsubstantiated health claims can also be made for OTC Drugs that do not have cosmetics claims on their labels and for foods and dietary supplements as well. Conservative companies take special care in ensuring labeling and advertising claims are truthful and/or substantiated as required by the FDA and FTC. Many others, however, take calculated risks in promoting products because they recognize that the agencies will tolerate a certain unquantified amount of puffery before issuing a Warning Letter or initiating a more aggressive enforcement action.
In reality, cosmeceuticals are drug products for nearly all labeling purposes and must bear all required OTC drug labeling including the established name, intended use, ingredient listings, warnings, use instructions, etc., all in a required format and type size. Labeling such a product in compliance with FDA rules can be burdensome because one must comply with several general labeling regulations in addition to the more specific requirements of the OTC Drug Monographs. An unusual requirement for cosmeceuticals is in listing inactive ingredients. While OTC drug inactive ingredients must be listed in alphabetical order, cosmeceutical inactives must be listed in the descending order of predominance in formulas (which is the requirement for cosmetics).
A good thing about most cosmeceutical products is that they are generally quite safe and have no dosage limitations. One could literally take a bath in most formulations with no adverse effect. Manufacturers often have research and development staffs working diligently to improve the cosmetic properties of their products such as moisturizing, hypoallergenic, emollient, exfoliant, and improved fragrances. Such properties make cosmeceuticals appealing to consumers as carriers of active topical drug ingredients and thus likely to be used as directed to achieve effectiveness.
Because during the past decade or two FDA has publicly touted its “risk-based” enforcement efforts to focus limited resources primarily on higher level health risks, enforcement in this area seems to have declined. I would prefer to see FDA increase enforcement actions in this area, which would help clarify label claim boundaries and level the playing field for competition.
See the Compliance Online website http://www.complianceonline.com/seminars for a description of the course “Manufacturing and Marketing OTC Drugs in Compliance with FDA Regulations (Emphasis on Topical Products) scheduled in Chicago, San Francisco and Boston this year in June, August and November respectively.
Do you think FDA should strengthen enforcement efforts where cosmeceuticals are
concerned? Are you comfortable with the lack of oversight? Comment below!
William Schwemer is an independent consultant who helps clients comply with FDA rules. He interprets FDA policies related to pharmaceuticals and personal care products, evaluates manufacturing practices against GMP regulations, reviews labeling and assists with regulatory strategies. He has been retained as an expert witness in 22 civil lawsuits on such matters. His profile is on LinkedIn. Contact: email@example.com, 540-20-9725.