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Changing FDA regs impact dermatologists, patients


Recent actions around drug compounding, sunscreen ingredient approvals, drugs and medical devices, cosmetic product marketing and more will affect your practice. Stay informed.

FDA regulations and actions impact medical and cosmetic dermatology; yet, keeping up with updates isn’t easy for busy dermatologists and their staffs. So Dermatology Times asked FDA insider and spokesperson Kristofer Baumgartner to update readers on recent FDA regulations and actions that impact the specialty, such as drug compounding, sunscreen ingredient approvals, drugs and medical devices, cosmetic product marketing and more.

Next: What dermatologists need to know


DT: What do dermatologists need to know about recent FDA regulations that might impact their daily practice?

Baumgartner: [From the Center for Food Safety and Applied Nutrition] There have not been significant changes to the cosmetic regulations since 1999, when a regulation was published regarding labeling of cosmetics that contain sunscreen ingredients that are intended to protect the product rather than the consumer (21 CFR 700.35).

However, something dermatologists do need to know, and which does affect their daily practice, is that the FDA has a voluntary adverse event reporting system for cosmetics. The law does not require cosmetic companies to share safety information, including consumer complaints, with the FDA. This means that without voluntary reports from healthcare professionals-especially dermatologists-and consumers, the FDA has no way of finding out if there are safety concerns associated with the use of cosmetic products and ingredients. The more complete information that dermatologists can provide, such as precise label and ingredient information, as well as test results, the more likely we’ll be able to identify the cause of the problem.

Next: Important differences between approvals for drugs and cosmetics




DT:What are some important differences between drug and cosmetic approvals and have there been any recent changes in either?

Baumgartner: [From the Center for Food Safety and Applied Nutrition] The FDA regulates cosmetics under the Federal Food, Drug, and Cosmetic Act of 1938 (FD&C Act) and, if they are marketed on a retail basis to consumers, the Fair Packaging and Labeling Act of 1967 (FPLA). Neither of these laws requires cosmetic products and ingredients, other than color additives, to have FDA approval before they go on the market.

However, cosmetics must be safe when consumers use them according to directions on the label or in the customary way, and they must be properly labeled. Companies and individuals-including dermatologists-who manufacture or market cosmetics have a legal responsibility for the safety and labeling of their products. The FDA can take action against cosmetics on the market that do not comply with the laws we enforce.

The FD&C Act defines cosmetics by their intended use, as "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance" (FD&C Act, sec. 201(i)). Among the products included in this category are skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup, cleansing shampoos, permanent waves, hair colors, and deodorants, as well as any substance intended for use as a component of a cosmetic product.

However, if the product is intended for a therapeutic use, such as treating or preventing disease, or to affect the structure or function of the body, it’s a drug (FD&C Act, 201(g)), or in some cases a medical device (FD&C Act, 201(h)), even if it affects the appearance. Drugs are subject to requirements, such as premarket approval. Some products are both cosmetics and drugs, and must meet the requirements for both product categories. Shampoos also intended to treat dandruff, facial cleansers intended to treat acne, moisturizers claimed to have ‘anti-aging’ effects on the structure or function of the skin or to treat conditions, such as eczema, are some common examples of products that are both cosmetics and drugs.

In determining whether a product is a cosmetic, a drug, or both, we consider how a product is marketed as a whole, not on a word or phrase taken out of context. For example, we evaluate 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, such as claims that products will restore hair growth, reduce cellulite, treat varicose veins, increase or decrease the production of melanin in the skin, or regenerate cells. We also consider consumer perception: why the consumer is buying it and what the consumer expects it to do, as well as ingredients that cause a product to be considered a drug because they have a well-known (to the public and industry) therapeutic use.

Next: What's the difference between marketing for cosmetics and cosmeceuticals?

Related: Cosmeceuticals for treating acne


DT: What do dermatologists need to know about the marketing of cosmetics and cosmeceuticals? And is there a difference between the two?

Baumgartner: [From the Center for Food Safety and Applied Nutrition] Neither the FD&C Act nor the FPLA recognizes the term ‘cosmeceutical.’ The cosmetic industry uses this word to refer to cosmetic products that have medicinal or drug-like benefits. If a product has drug properties, it must be approved as a drug.

The FDA has issued warning letters to a number of firms that have marketed products with unapproved drug claims. These products include skincare products, hair restoration products and eyelash/eyebrow growth treatments.

We have taken enforcement action against products intended to promote eyelash growth using prescription drug ingredients for a non-approved purpose.

DT: Have there been regulatory changes in the compounding of human drug products? Please explain how those might specifically impact a dermatological drug.

Baumgartner: Since enactment of the Drug Quality and Security Act (DQSA) in 2013, the FDA has moved quickly to develop policies to implement the compounding provisions of the law. (See “Resources”)

Next: What's new in approvals for sunscreens and drugs?


DT: What’s new in approvals for sunscreen ingredients, drugs?

Baumgartner: [From the Center for Drug Evaluation and Research] In the U.S., sunscreens are regulated as drug products, and, as such, they must meet certain standards to ensure they are safe and effective for daily, lifelong use by consumers.

Unlike other countries that regulate sunscreens as cosmetics, the U.S. regulates sunscreens as nonprescription (also known as over-the-counter or OTC) drug products. Drug products are held to different and stricter standards than cosmetics, both in the U.S. and in other countries.

Most sunscreen products currently available in the United States are marketed without approved new drug applications under the FDA’s over-the-counter (OTC) drug monograph system. Among other things, the OTC sunscreen monograph currently identifies 16 active ingredients that may be marketed in nonprescription sunscreen products that otherwise comply with the monograph and related regulations. Nonprescription sunscreen products that contain other active ingredients may also be marketed in the United States, but require product-specific premarketing review and approval by the FDA.

The FDA is currently considering eight pending requests for determinations that additional sunscreen active ingredients are ‘generally recognized as safe and effective’ (GRASE) (GRASE determination requests), using procedures established by the Sunscreen Innovation Act (SIA) (enacted November 26, 2014). To date, those active ingredients have been used only in sunscreen products marketed outside the United States, or in U.S-marketed products with approved NDAs.

The eight ingredients that have been submitted by industry for inclusion in the sunscreen monograph are:

  • Enzacamene

  • Ecamsule

  • Diethylhexyl Butamido Triazone

  • Amiloxate

  • Octyl Triazone

  • Drometrizole Trisiloxane

  • Bisoctrizole

  • Bemotrizinol

The agency has made it clear to industry and the public that further data are needed to support final GRASE determinations for the eight pending sunscreen active ingredients, as detailed for each active ingredient in proposed sunscreen orders issued during 2014 and 2015. However, despite these efforts the FDA has not received any additional data from manufacturers for any of the eight pending sunscreen ingredients.

The FDA’s GRASE determinations for sunscreen active ingredients must be supported by safety and effectiveness testing data submitted to the Agency by active ingredient sponsors, including studies evaluating whether, and to what extent, sunscreen active ingredients are absorbed through the skin into the body.

The FDA must carefully evaluate both the safety and effectiveness of the active ingredients in nonprescription drug products, taking into consideration how sunscreen products are used by consumers. In particular, the FDA must consider that these products are intended to be used without medical supervision by a large percentage of the consumer population (including vulnerable populations such as young children and pregnant women), and that they are recommended for regular, life-long use in liberal amounts and over large portions of the body surface whenever consumers are exposed to the sun.

Even though the protective action of sunscreen products takes place at the skin surface, there is evidence that at least some sunscreen active ingredients may be absorbed through the skin into the body, making it important to complete studies in humans to determine whether, and to what extent, consumers’ use of sunscreen products as directed may result in unintended, chronic, systemic exposure to sunscreen active ingredients.

The FDA remains committed to working with industry to provide American consumers with additional options for safe and effective sunscreen ingredients. However, the FDA must rely on industry to submit required data for review in order to support a GRASE determination.

Next: Regs for indoor tanning

Of similar interest: 2016 sunscreen recommendations


DT: Finally, please describe current and upcoming changes in indoor tanning regulations.

Baumgartner: [From the Center for Devices and Radiological Health] The rules proposed in December 2015 (see “Resources”) were draft rules, which means they do not take effect until they are finalized. The agency received thousands of comments on the proposed rule. We are reviewing the comments and will communicate with the public when we have additional information or a timeline to share.

In the meantime, users should remember that sunlamp products currently must include statements on the device warning against their use by youth under 18. User should also understand the following points:

Failure to wear appropriate protective eyewear, such as goggles, can lead to short- and long-term eye injury.

Long exposures (close to the maximum time for the sunlamp product), can lead to burning. Because sunburn takes 6 to 48 hours to develop, you may not realize your skin is burned until it is too late.

You should follow the manufacturer’s recommended exposure times on the label. People with skin that burns easily and does not tan should never use indoor tanning devices.

Tanning while using certain medications or cosmetics may make you more sensitive to UV radiation. Talk to your doctor or pharmacist first.

Note: FDA experts, including dermatologists with the FDA, tackled this topic in the presentation “The Evolving Regulatory Landscape” at the American Academy of Dermatology annual meeting in early March.

Next: Resources



Cosmetic-related adverse events

Dermatologists can report cosmetic-related adverse events as follows:

  • Telephone 1-800-FDA-1088.

Unapproved drug claims

See warning letters that address drug claims made for products marketed as cosmetics, at http://www.fda.gov/Cosmetics/ComplianceEnforcement/WarningLetters/ucm081086.htm.

The Import Alert for anti-aging products marketed with unapproved drug claims can be viewed at (Import Alert #66-38: Skin Care Products Labeled as Anti-Aging Creams): http://www.accessdata.fda.gov/cms_ia/importalert_188.html.

Compounding policies

The FDA has received information from organizations representing dermatologists that they are particularly interested in FDA’s policies regarding bulk drug substances to be used in compounding and compounding for office stock. Therefore, the following guidance documents may be of particular interest to the dermatologic community:

Final guidance: Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry (PDF - 126KB)

Final guidance: Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act Guidance for Industry (PDF - 105KB)

Draft guidance: Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act

A complete list of the policy documents that FDA has issued to implement the compounding provisions of the law appear on FDA’s website at: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm166743.htm.


In December 2015, the FDA proposed new safety measures for indoor tanning devices: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm350790.htm


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