There are many far-reaching claims being made by cosmetics companies including suggestions that their products are anti-aging, age-defying or revitalizing. The companies are able to do so because the cosmetics industry is largely unregulated by the FDA, allowing misleading claims to go unchecked. This does not mean that cosmetics companies can make false statements in their promotional materials, however–they still must adhere to certain FTC and FDA requirements to stay compliant. 

What Differentiates Cosmetics from Drugs?

Intended Use

Cosmetics are regulated in a different way than drugs, primarily because they are categorized by different intended uses. The FD&C Act defines drugs as being “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” as well as “articles (other than food) intended to affect the structure or any function of the body of man or other animals.” This differs from cosmetics, which are defined by their use 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.” Because drugs and cosmetics have separate intended uses, they are governed by different regulations. While drugs fall completely under FDA oversight, and are subject to strict, rigorous standards, marketing claims for cosmetics are more loosely regulated by the Federal Trade Commission (FTC). 

FDA Requirements

Cosmetics are also held to different FDA requirements than drugs. While drugs must meet safety and efficacy standards, and also demonstrate that they are not misbranded or adulterated, cosmetics primarily need to meet the last two requirements. This means that cosmetics companies must prove that their products are pure, and do not have additional substances diluting them. They must also label their products properly, and not make claims falling outside of the product’s intended use. Efficacy, however, is not required for cosmetics–meaning that cosmetics do not need FDA pre-market approval (except for color additives). As a result, cosmetics are able to reach the market much quicker than their drug counterparts, and are subject to fewer regulations.

Defining Intended Use

For cosmetics, intent is defined by looking at the manufacturer’s claims explicitly promoting a product for a particular use, or by considering the circumstances surrounding the distribution of the product. This means that companies using social media influencers to promote their products should be wary about the statements being used. If a company tells its influencers to make false claims about its product, it could end up violating FTC regulations. Companies should also be cautious about consumer perceptions, or the reason why customers are buying their products. This is yet another factor which can count toward defining a product’s intent. Cosmetics manufacturers should keep both of these factors in mind when advertising their products to ensure they stay compliant with FDA and FTC regulations. 

Are Misleading Claims Allowed?

Cosmetic products such as anti-aging creams making deceptive health claims are not likely to work as advertised. This is because the regulatory body responsible for regulating cosmetics claims, the FTC, only requires what is called competent and reliable scientific evidence. This constitutes tests, analyses, research studies or evidence based on the expertise of professionals in the relevant field. Although these procedures will generally produce accurate and reliable results, they are not conclusive. This means that, although a cosmetic product may claim to help reduce signs of aging, it will likely not work because there is not much scientific proof required for them to make that claim. Because the scientific standards that cosmetic companies have to meet are so low, they are able to make seemingly deceptive claims in advertising with very little evidence to back their claims. As a consequence, misleading claims have run rampant in the cosmetic industry with very few regulations keeping them in check.

Conclusion

Although cosmetics companies occupy a very unregulated space, it is still possible for them to end up violating FDA and FTC requirements. Cosmetics manufacturers should consider consulting with a legal expert to ensure that their promotional materials are compliant with state and federal regulations.

If you have any other questions about how to communicate with the FDA or how your past and/or current FDA communications affect you and your business goals, reach out to me on Twitter, LinkedIn, or send me a message here.

I also host a podcast called DarshanTalks, a show that discusses newsworthy FDA issues and how they apply to bringing a product to market – and keeping it there. From patient centricity in clinical trials to the government shutdown to CRISPR and bioethics to why big data is doomed to fail in healthcare, we’ve got quite the list of topics to review! Listen to the podcast on Google Play or on Soundcloud.