Cosmeceuticals: How to Navigate the Legal and Regulatory Hurdles of a Growing Market

The cosmeceuticals market continues its steady climb upward—a rise in disposable income plays a role, as well as the introduction of new ingredients that promise anti-aging, photoprotective, redness-reducing, and other skincare enhancing benefits.

Are those claims clinically proven? Product manufacturers should know what constitutes a legitimately clinically proven cosmeceutical, as well as what the FDA has to say about these cosmetic-drug hybrids.

What is a cosmeceutical?
The cosmetics industry uses the term cosmeceutical to refer to a cosmetic product with medicinal or drug-like benefits according to the FDA. The FDA recognizes, however, that the term has no legal meaning under the Federal Food, Drug, and Cosmetic Act. (FD&C Act).

To distinguish cosmetics from cosmeceuticals, consider intended use. If a product’s intended use is to “treat or prevent disease or otherwise affect the structure of the human body,” but it’s marketed as a cosmetic, the product falls into cosmeceutical territory.

A few cosmeceutical examples include:

• An eye cream that contains special ingredients to potentially regenerate cells or boost collagen production.

• An essential oil that claims to promote better sleep.

• A gel that both moisturizes skin and relieves muscle or joint pain.

• An anti-dandruff shampoo.

Cosmeceutical regulatory requirements

Laws and regulations differ greatly between drugs and cosmetics. Under the FD&C Act, drugs are intended for use in the cure, mitigation, treatment, or prevention of disease and/or are intended to affect the structure or any function of the human body.”

The Act defines cosmetics 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.”

Drugs must be submitted for FDA approval. Cosmetics are not.

Cosmetic companies may violate the FD&C Act if they market a cosmetic using a drug claim, or by marketing a drug as if it were a cosmetic without following FDA drug regulations. Conversely, if a drug manufacturer markets a product as a cosmetic, but its intended use falls under the scope of a drug, it may violate the FD&C Act.

Botanical cosmeceuticals

Drugs or cosmetics that contain botanticals—products with ingredients that include plant materials, algae, macroscopic fungi, or some combination—are subject to additional considerations. Botanical drugs have to show by a “totality of evidence” that the therapeutic effects are consistent within and between product batches.

Botantical cosmeceuticals may contain herbal extracts such as rosemary, propolis, and grape seed extract. Other common natural ingredients include arnica, bromelain, chamomile, and green tea.

Cosmeceutical legal implications

A cosmeceutical; which, under the FD&C Act, falls under the cosmetic-drug combination category, may contain copper peptides or fruit stem cells or some other product with potentially skin-altering properties. To avoid FDA oversight, and a potential lawsuit, cosmeceutical manufacturers need to be mindful of their marketing and advertising claims.

In 2000, the FTC filed suit against Rexall Sundown. The company marketed a product that claimed to “eliminate cellulite,” among other statements. No product will eliminate cellulite. Even noninvasive surgical procedures only reduce or improve cellulite—temporarily. The FTC ordered Rexall Sundown to pay up to $12 million in redress for its misleading claims.

In 2015, cosmetics leader L’Oreal received an FDA warning letter for its Rosalic AR Intense and Mela-D Pigment Control products. The FDA asserted that the products were unapproved new drugs based on these and other marketing claims:

• “Localized redness intensive serum.”

• “Recommended for: redness-prone skin, experiencing overall redness, flushing and sensations of discomfort.”

• “I have rosacea on my neck when I get warm or under stress. This product really works to keep it under control.”

Good manufacturing practice

The FDA advises cosmetics manufacturers to follow Good Manufacturing Practices (GMP) to reduce risk of misbranding or mislabeling. GMP guidelines include production practices, label placement, placement of information on labels, how to list ingredients, and other details.

Importantly for cosmeceuticals, GMP also provides specific warning statement guidelines. Under 21 CFR 740.10, a cosmetic is considered misbranded if the manufacturer did not adequately substantiate its safety, and did not include the following statement on label:

“Warning – The safety of this product has not been determined.”

What qualifies as “adequately substantiated?” Scientific experts reasonably concluded, using toxicological and other test data, chemical composition, and additional information, that the product “is not injurious to consumers under conditions of customary use and reasonably foreseeable conditions of misuse.”

Is it really “clinically proven?”

Ideally, a cosmeceutical would undergo rigorous testing for efficacy; possibly a valid, randomized controlled clinical trial. However, some cosmetics companies use the term more broadly.

A Reuters reporter analyzed the randomized controlled clinical trial conducted for Inneov Sun Sensitivity, a nutritional supplement “clinically proven” to give users a nice tan while protecting them from UV rays. During the trial, researchers didn’t compare results between the supplement-taking and placebo groups, which led to insignificant conclusions.

“Clinically proven” should mean the results were significant and able satisfy regulatory requirements. For some companies, however, it’s a catch phrase without much meaning. Follow the former approach; not the latter.

A CRO with extensive dermatological experience can help drug manufacturers navigate challenging regulatory guidelines for cosmeceutical and pharmaceuticals studies. Biorasi has the extensive global regulatory experience as well as scientific and medical affairs experts who can help companies determine a study design that both “clinically proves” the product while controlling the costs. Contact us today to learn more.

Stephanie Munroe, PhD
Stephanie Munroe, PhD
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