Expert's Opinion

Coloring within the Lines

By Raqiyyah Pippins, Kelley Drye & Warren LLP | February 10, 2014

Insights regarding the 2013 FDA Warning Letters issued to personal care product companies.

The past few years have been marked with an increase in scrutiny of personal care products by the Food & Drug Administration (FDA),[1] including FDA efforts to define the regulatory boundaries governing different classes of personal care products and clarify the regu­­­­­latory distinction between cosmetics and drugs.  After hinting to industry in 2011 that it intended to monitor the category, FDA issued a series of warning letters in 2012 emphasizing its concerns regarding the use of hair removal, ant-aging, and blemish removal related claims for products labeled as cosmetics, asserting its position that such claims cross the “lines” for cosmetic products and cause such products to be drugs under the FDCA.[2]   In 2013, FDA re-affirmed its position regarding the types of beautification claims that it considers to be  drug claims, while also highlighting some new-areas for consideration:  specifically, the regulatory lines governing beautification devices, personal care products for diseased populations, and third-party contractors.

Reaffirming Past Priorities

Last year, we discussed FDA’s scrutiny of personal care products and the manner in which a personal care product’s regulatory classification can significantly impact the regulatory standards governing the product’s manufacturing, marketing and labeling.[3] For example, before being marketed, products classified as OTC drugs must either receive pre-market approval by FDA or conform to FDA monographs- -essentially an FDA-approved formula for a drug product. In contrast, 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.[4] 

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 covers (e.g., advertisements, websites, labeling, and ingredient statements) as evidence of a product’s intended use.   Products marketed with drug claims—claims that a product is “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body”—without pre-market approval by FDA or conforming to FDA monographs are considered “unapproved new drugs” and cannot be legally marketed in the United States.[5]

In 2013, FDA reaffirmed these priorities with more warning letters regarding unapproved anti-aging, blemish removal, and hair-removal product claims that caused the products to be unapproved new drugs.  For instance, FDA’s March 2013 warning letter to Keystone Laboratories, Inc.[6] regarding its personal care products is an example of FDA’s efforts to continue monitoring the category.  The letter was largely consistent with previous FDA action challenging the use of claims and/or ingredients that FDA considers to be evidence that a product is intended for use as an unapproved new drug, including allegations that the inclusion of recognized drug ingredients (e.g., hydroquinone 2% and padimate o 1.5%) as active ingredients and blemish removal claims (e.g., “fades skin discoloration by lightening dark spots such as freckles, age spots, and blemishes”) caused the company’s ULTRA GLOW Fade Cream products to be drugs under the FDCA.  However, the letter also serves as a reminder that FDA is monitoring personal care products to ensure that products marketed with claims that are covered by an OTC drug monograph are consistent with the conditions established by the monograph to exempt the company from obtaining additional pre-market approval for promoting the product in the United States. 

In its letter to Keystone Laboratories, FDA alleged that the packaging and labeling for Keystone Laboratories’ Long Aid Medicated Hair Revitalizer Anti-Itch Formula indicated that the product is intended for the control of dandruff and microbial use.   While the dandruff indication of use is addressed under 21 CFR 348 Subpart H—the OTC monograph covering certain claims for “Drug Products for the Control of Dandruff, Seborrheic Dermatitis, and Psoriasis,”  FDA alleged that the Long Aid Medicated Hair Revitalizer Anti-Itch Formula product is misbranded because the product also included claims that the product was intended to control microbial growth.  Specifically the letter stated that because this “antibacterial indication… is not included as an indication for use in the OTC Final Monograph for Drug Products for the Control of Dandruff, Seborrheic Dermatitis, and Psoriasis… the  product is not labeled in accordance with monograph.”  Essentially, the inclusion of drug claims that were not covered by the monograph caused Keystone to lose its exemption from obtaining premarket approval for its salicylic acid-based anti-dandruff shampoo product by causing the product to become a new drug without proper approvals. As noted above, new drugs cannot be legally marketed in the United States without approved applications under Section 505(a) of the FDCA.

Asserting New Priorities

Beautification Devices.  In 2013, FDA expanded its scrutiny of compliance with pre-market approval exemptions for devices.  For example, in a warning letter to Market Technologies, Inc.,[7] FDA alleged that the company’s Contour Ultra and Starpress devices were being marketed as unapproved medical devices in violation of the FDCA.  Notably, this warning letter involved electric therapeutic massagers that can be legally marketed under 21 CFR 890.5660 without premarket notification, provided they are intended for relief of minor muscle aches and pains or to temporarily relieve minor muscular pain or tension caused by fatigue or overexertion.  Market Technologies, however, was marketing the product to provide beautification benefits, with claims such as “improves skin quality,” “improves muscle tone in the face and neck,” “visibly reduces wrinkles,” and treats cellulite.  FDA considered the claims to be “evidence the [devices are] intended for uses that are different from those legally marketed devices classified under 21 CFR 890.5660,” and therefore required Marketing Technology to obtain premarket approval prior to marketing the products in the United States.  Because the claims “exceed[ed] the limitations described in 21 CFR 890(a)” that would have exempted the devices from premarket notification requirements, FDA concluded that the devices were misbranded and in violation of the FDCA.

Personal care products for disease populations.  Given the impact that disease can have on the appearance of the body, some companies have considered marketing personal care products to support the needs of disease populations that are concerned about the impact of their condition on their outward appearance.  In 2013, FDA issued warning letters suggesting that FDA may consider such products to be drugs under the FDCA.  For example, on July 15, 2013, FDA sent a warning letter to The Magni Group, Inc. regarding claims made for the company’s “Diabetic Foot Cream” and “Diabetic Hand & Body Cream” products, alleging that the products are “intended for use in the diagnoses, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or any function of the body.”[8]   Notably, claims of concern to the company included the product names-- “Diabetic Foot Cream” and “Diabetic Hand & Body Cream” and the claim, “[O]ne of out of every three people with diabetes will be affected by skin disorders caused by diabetes.  Fortunately, most skin conditions can be prevented or easily treated if caught in the early stages.  It is important to maintain healthy skin with skin care products specifically developed for people with diabetes.”  FDA considered these product names and the claim to be evidence that the products were intended for use as drugs and “new drugs” under FDCA section 201(p) “because they are not generally recognized as safe and effective under the conditions prescribed, recommended, or suggested in their labeling.”  It then concluded that because “a new drug may not be introduced or delivered or introduction into interstate commerce unless an FDA-approved application is in effect for it,” and “there are no FDA-approved applications for these products,” “the marketing of these products constitutes a violation of these provision of the [FDCA].”

Contract-based testing laboratories.  In 2013, FDA also asserted its position regarding the use of third party agents to monitor compliance with FDA regulations.  In August 2013, FDA sent a warning letter to Jabones Pardo S.A.,[9] based on an inspection of their manufacturing facility in Madrid, Spain.  After determining that many of its personal care products that were to be sold in the United States were out of compliance with FDA regulations, the letter addressed the use of contract testing laboratories, noting the following:

“Although you have agreements with other firms that may delineate specific responsibilities to each party (e.g., quality control testing), you are ultimately responsible for the quality of your products.  The Food & Drug Administration is aware that many manufacturers of pharmaceutical products utilize extramural independent contract facilities (e.g., contract testing laboratories) and regards extramural facilities as an extension of the manufacturer’s own facility. Regardless of who performs your operations, or agreements in place, you are required to ensure your products were made in accordance with…the Act so as to provide for their identity, strength, quality, purity, and safety, and are suitable for marketing.”

As companies continue to rely on third party laboratories to ensure compliance with FDA regulations, this letter reinforces the importance of actively monitoring the quality and efficiency of the contracted laboratories.   

What Does It Mean?

FDA activity in 2013 indicates that FDA is continuing to monitor the industry and that care should be taken to ensure that the marketing and manufacture of personal care products is aligned with FDA standards.  It also provides some helpful tips for companies attempting to expand their product portfolios:

·       When rebranding products, ensure that new product claims do not fall outside of the scope of the approvals permitting use of the product in the United States. Read both the monographs and the rulemaking records for drugs and devices subject to premarket approval to determine the types of claims that were contemplated by the agency when establishing the OTC monographs or premarket exemptions for the drug or device, and confirm that claims of interest to the marketing team were not rejected by FDA when establishing the monograph or premarket exemption currently applying to the drug or device.  It also is helpful to ensure claims of interest to the marketing team that are not well accepted cosmetic claims or  included in the monograph or premarket exemption that applies to the company’s product are not expressly approved for use to market other drugs or devices.  Typically, FDA’s inclusion of a claim in a drug approval for another product indicates FDA’s position that the representation is a drug claim under the FDCA.  Thus applying the claim to a product in commerce as a cosmetic or  pursuant to an OTC monograph or premarket exemption presents high risk of leading FDA to conclude that the new claim causes the product to be an unapproved “new drug”;

·       Acknowledge the risk of targeting personal care products at diseased populations.  To the extent that a company chooses to pursue products targeted at such populations, care should be taken to avoid terms that refer to skin “disorders” and to instead “highlight an intention for the product 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 skin”[10]; and

·       Closely vet and monitor third-party vendors prior to relying on such entities to ensure compliance with FDA regulations.  For example, companies should ensure that vendors are aware of (and in compliance with) FDA’s Draft Guidance for Industry:  Cosmetic Good Manufacturing Practices, issued in June 2013.[11]  Written assurance alone from a third-party vendor that it intends to comply with FDA’s regulations is unlikely to shield a company from liability under the FDCA. In addition, ensure that all contractual agreements with third-party vendors delineate the vendors’ obligations in the event of regulatory enforcement or related action.
Taken together, these steps can help companies to “color within FDA’s regulatory lines” in an effort to minimize the risk of FDA enforcement action regarding the company’s personal care products.

[1] For the purposes of this article, “personal care product” is defined to include any product (including a device) that is topically applied to improve a person’s appearance. 
[2] Judging a Book by Its Cover: FDA’s Scrutiny of Personal Care Products in 2012, FDLI Update Magazine March/April 2013.
[3] Id.
[4] In fact, color additives are the only cosmetic ingredients that must be pre-approved by FDA.
[5] FDCA section 505(a).
[6][6] FDA Warning Letter to Keystone Laboratories (Mar. 18, 2013)
[7] FDA Warning Letter to Market Technologies, Inc. (Dec. 2, 2013).
[8] FDA Warning Letter to The Magni Group, Inc. (Jul. 15, 2013).
[9] FDA Warning Letter to Jabones Pardo, S.A. (Aug. 22, 2013).
[10] FDA Website, “Is it a Cosmetic, Drug, Or Both? (Or is it Soap?)” available at
[11] FDA Website, “Guidance for Industry:  Cosmetic Good Manufacturing Practices” (June 2013) available at

About the Author
Raqiyyah Pippins is an associate in the firm’s Washington, D.C. office.  She focuses her practice on food and drug law and consumer law matters, including advertising, FDA-regulated product labeling, Rx-to-OTC switches, and related regulatory and litigation considerations. Pippins counsels and defends companies that are engaged in the development, marketing, import and/or export of food, drugs, cosmetics, medical devices, biologics and veterinary products.

Pippins has particular experience representing companies in advertising challenges and defending food and pharmaceutical companies in legal investigations conducted by the Food and Drug Administration (FDA), the Federal Trade Commission (FTC), and state agencies concerning product marketing practices.  She also advises companies on mechanisms for limiting the risk of marketing-related challenges by regulators or private litigants, with a primary focus on minimizing the risk associated with the development, labeling and marketing of FDA-regulated products.

More info: Raqiyyah Pippins, Tel: (202) 342-8527; Email:; Website: