It is often said that “beauty lies in the eye of the beholder.” A review of Food & Drug Administration (FDA) enforcement activity in 2011 reinforces how personal care products are beheld by FDA. This article highlights important regulatory considerations for personal care product manufacturers and marketers, as evidenced by FDA enforcement activity over the past year.
FDA Regulation of Personal Care Products
The Federal Food Drug and Cosmetic Act (FDCA) grants FDA the authority to regulate a number of products, including all cosmetic products destined for the U.S. market.All FDA-regulated products must comply with the FDCA and FDA’s related implementing regulations.Violations of the FDCA can result in both civil and criminal penalties.
For the purposes of this article, “personal care products” are defined to include any product that is topically applied to improve a person’s appearance.Importantly, “personal care products” has no legal definition, but is commonly used to refer to cosmetics and nonprescription drugs.Generally, FDA-regulated personal care products fall into two categories, cosmetic or drug. Their legal definitions are as follows.
Cosmetic. One, any article that is “intended to be rubbed, poured, sprinkled or sprayed on, introduced into or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness or altering the appearance; or two, (any) article intended for use as a component of any such article, except that such term shall not include “soap.” Examples include, lipstick, nail polish, eye makeup, hair color or skin moisturizers.
Drug. One, articles recognized in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; two, articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and three, articles (other than food) intended to affect the structure or any function of the body of man or other animals. Examples include antiperspirant, wrinkle reducers, shampoos intended to treat scalp diseases (e.g., seborrheic dermatitis), facial creams intended to treat acne or rosacea.
How FDA categorizes a personal care product is determined, in part, by what FDA concludes to be the manufacturer’s “intended use” for the product. Among other things, FDA reviews product advertisements, websites, labeling and ingredients as evidence of a product’s intended use. A personal care product can be both a drug and a cosmetic; i.e., an antiperspirant that also deodorizes. In these cases, the product must comply with FDA requirements that apply to drugs as well as cosmetics.
At times, manufacturers of personal care products strive to have products classified as cosmetics (and not drugs) because cosmetic products have fewer pre-market clearance requirements than OTC drugs. For example, before being marketed, products classified as OTC drugs must either receive pre-market approval by FDA or conform to FDA monographs. A monograph essentially is an FDA-approved formula for a drug product. While cosmetic manufacturers are responsible for ensuring product safety, products classified as cosmetics do not need to obtain pre-market FDA approval or conform to a specified pre-approved FDA formula. In fact, color additives are the only cosmetic ingredients that must be pre-approved by FDA. Thus, a personal care product’s regulatory classification can deeply impact the regulatory standards governing the product’s manufacturing, marketing and labeling.
FDA Regulation of Personal Care Products in 2011
In 2011, FDA sent several warning letters to manufacturers alleging that their personal care products were in violation of the FDCA. A warning letter is official correspondence from the FDA and, frequently, is FDA’s first step in the enforcement process. Taken together, FDA’s warning letters to personal care product manufacturers reinforce that, above all else, product claims, ingredients, and safety impact how a personal care product is beheld by FDA.
As already noted, a product may be considered a drug if product claims suggest the product is (a) intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease (“disease claims”) or (b) intended to affect the structure or any function of the body (“structure/function claims”). In recent years, an increasing number of structure/function claims have emerged in the marketing for skin care and other personal care products. FDA’s 2011 enforcement activity serves as a reminder that such marketing claims can readily change the legal status of a product from “cosmetic” to “drug,” thereby subjecting the product to the full range of FDCA requirements that apply to drugs.
For example, in March 2011, FDA issued a warning letter to JabaLabs LLC
, alleging that three of its anti-aging skin care products are “drugs” under the FDCA, on the basis that claims that the products could “accelerate collagen and elastin production,” “restore firmness and elasticity,” and “reduce expression lines & deep furrows” “establish that the products are intended to affect the structure or function of the human body.”Other alleged “drug” claims include “Lose your wrinkles! Without painful injections,” “reverse chronological aging” and “protect skin from free radical damage.” A month later,FDA issued a similar warning letter to Lifetech Resources LLC
alleging that claims that its eyebrow and eyelash products “lengthen and thicken lashes,” “grow your lashes” and “help accelerate the length of the hair shaft, while promoting a fuller, thicker, and healthier looking brow” caused the products to be drugs under the FDCA. This letter alleges that “inducing eyelash and eyebrow growth” is affecting the structure or functions of the body.
FDA’s scrutiny of marketing claims was further reinforced by an import alert
issued in Spring 2011, in which FDA specifically highlighted terms it believed to represent an intent for anti-aging products to be used as drugs. According to the alert, statements that products “counteract,” “retard,” or “control” the aging process are presumptively viewed as evidence of an intent to sell a product as a drug, while statements that a product can “rejuvenate,” “repair,” or “restructure” would be viewed as drug claims, depending on context. While directed specifically at anti-aging products, the import alert is especially notable given the prevalence of these terms in the marketing for various personal care products presumed to be cosmetics by their manufacturers.Unanticipated regulatory classification as a “drug” can deem these products in violation of the FDCA, thereby subjecting imported products to detention, and product manufacturers to potential liability.
Last year’s actions also reinforced the role of product formulations in FDA’s regulatory classification of a personal care product. Simply put, including an active ingredient in the formulation for a personal care product that also is found in an FDA-approved drug product can cause FDA to classify the personal care product as a drug. Notably, in the April 2011 letter to Lifetech Resources LLC
, FDA highlighted that Lifetech’s products contained the active ingredient isopropyl cloprostenate. Isopropyl cloprostenate is a synthetic prostaglandin analog that FDA considers to be in the same class of compounds as the active ingredients in FDA-approved drugs indicated to lower intraocular pressure in glaucoma patients. Accordingly, FDA alleged that, among other things, the presence of isopropyl cloprostenate indicated Lifetech’s intent for the product to be a drug used to affect the structure or function of the body. In fact, FDA took the position that the presence of isopropyl cloprostenate made the products inherently unsafe for use except under the supervision of a practitioner licensed by law to administer the products. It then classified Lifetech’s personal care products as unapproved prescription drugs distributed without adequate instructions for use or the requisite approvals required for such products by the FDCA.
Although classification as a cosmetic can help companies to avoid unduly burdensome pre-market clearance requirements, it does not completely insulate a personal care product from FDA scrutiny. In 2011, FDA enforcement activity reinforced that cosmetic safety concerns will be closely monitored by the agency. For example, on Aug. 22, 2011, FDA issued a warning letter to GIB LLC
regarding its Brazilian Blowout products. According to the letter, FDA received information that inhalation of formaldehyde from the Brazilian Blowout causes various adverse events, including eye disorders, nervous system disorders, respiratory tract issues, nausea hypotrichosis, chest pain, chest discomfort, vomiting and rash. These adverse events were allegedly caused by the inadvertent inhalation of formaldehyde while heat was applied to hair treated with the product.
FDA interpreted these reports and related testing as sufficient evidence that the product was unsafe. In the warning letter, FDA alleges that the “Brazilian Blowout is an adulterated cosmetic because it bears or contains a deleterious substances [methyl glycol, the liquid form of formaldehyde] that may render it injurious to users under the conditions of use prescribed in the product labeling.” Classification of the Brazilian Blowout as an adulterated cosmetic caused the product to be in violation of the FDCA.
What Does this Mean for Companies?
An unanticipated FDA warning letter can be costly for a company. In addition to adverse publicity, an unexpected “drug” classification or safety concern can destroy a product launch or marketing schedule. Moreover, FDA warning letters alleging safety concerns can make a manufacturer vulnerable to piggyback class action lawsuits
under state law.
FDA’s 2011 enforcement activity highlights three steps personal care product manufacturers and marketers can take to mitigate the risk of FDA enforcement action:
1.Avoid product claims that imply physiological improvements to the body or hair.
FDA’s 2011 warning letters emphasize the care with which claims must be made for personal care products. According to FDA guidance
, cosmetic products are intended to exert a physical
but not physiological
effect on the human body. Generally, claims that represent a product to have a physical effect, without causing the product to be a “drug,” include “moisturize,” “refresh,” “soften,” “clean,” and “deodorize.” Approved cosmetic claims also include claims that a product causes a body party to “appear” different (e.g., “makes lashes appear longer”). In contrast, such claims as “revitalize cells,” “restore hair growth,” and “reduce cellulite” are believed by FDA to represent a product to have physiological effects on the structure or function of the body and, consequently, are reserved for “drug” products under FDA enforcement policies.
2.Closely scrutinize product formulations to ensure that novel product ingredients are not active drug ingredients or derivatives in FDA-regulated drug products. Product ingredients can serve as presumptive evidence that a product is a drug. Care should be taken to ensure that active ingredients are not also present in FDA-approved drug products. This is especially important when encountering novel product ingredients that do not have a history of use in cosmetics.
3. Monitor post-market adverse event reports. FDA’s primary responsibility is to protect the public health. Therefore, any product that has a reputation for posing safety concerns will become a regulatory priority for FDA. FDA does not pre-screen cosmetics; instead it follows the pulse of the public. Thus, manufacturers should closely monitor the feedback provided by product users in hopes to address any safety concerns prior to their receipt and review by FDA. FDA should not hear of adverse events before you.
FDA enforcement activity serves as a reminder that FDA is monitoring personal care products in an effort to ensure compliance with the FDCA. Special attention to product claims, ingredients, and safety, however, can help your personal care products to withstand the scrutiny of their ultimate beholder, FDA.
About the Author
Raqiyyah R. Pippins is an associate in the Advertising and Marketing and Food and Drug Law practices at Kelley Drye & Warren LLP in Washington, D.C. Contact her directly at email@example.com or learn more about the firm at www.kelleydrye.com.