FDA Warns Cosmetics Manufacturers Claiming Medical Cures

The FDA just sent warning letters to a series of cosmetics manufacturers. Gil C / Shutterstock.com

Consumers place an immense amount of trust in the labels on products they wish to buy. For any kind of complex manufactured goods, consumers are entirely reliant on product labeling to understand the contents of the purchases.

If these labels happen to be inaccurate, or make false claims about their effects, can consumers tell the difference?  The truth is, probably not.

The most recent example of this can be seen in a warning letter sent by the U.S. Food and Drug Administration (FDA)  to Chaga Mountain, Inc., a small family-owned business operating out of Maine.

After an inspection of Chaga Mountain’s manufacturing facility and a review of the company’s website in 2014, the FDA found “serious violations” of the Federal Food, Drug and Cosmetic Act (FD&C Act) and its implementing regulations.

The FDA, which implements several complex regulatory mechanisms to deal with the labeling of food, drugs and cosmetic products within the U.S., and companies are expected to fall in line or face the consequences.

According to the FD&C Act, the definition of cosmetics includes their use for “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”.

Conversely, the Act defines drugs as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body or man or other animals”.

While the difference between cosmetics and drugs might appear clear-cut, it becomes more complicated when cosmetic products such as topical creams claim to treat medical conditions.  Unless these products have been officially submitted to the FDA for drug approval, the claims are considered misleading and unverified.

Of major concern in the Chaga Mountain case was the fact that several Chaga Mountain products were intended for use “in the cure, mitigation, treatment or prevention of disease and/or articles intended to affect the structure or any function of the human body, rendering them drugs under the Act”.

The specific products in question included Chaga Mushroom Tincture/Extract – Alcohol Free; Chaga Mushroom Tea Bags; Chaga Mushroom Powdered Loose Teas; and Chaga Skin Cream and Lip Balm with natural ingredients including natural Essential oils.

Chaga Mountain claimed that the products can treat conditions such as cancer, HIV/AIDs, arthritis, influenza, swine flu, Alzheimers disease, Down syndrome, some forms of hepatitis and erectile dysfunction, just to name a few.

Chaga mushrooms have traditionally been used in Russian and Eastern European folk medicine to treat various illnesses.

However, the FDA says it does not recognize the products as safe and effective for the treatment of the conditions advertised on the Chaga Mountain website.

In addition, some of the products advertise treatment for medical conditions that are “not amenable to self-diagnosis and treatment by individuals who are not medical practitioners”.

Simply put, the FDA says that the labels cannot have legally adequate written directions for safe use by a layperson, which is also a violation of the FD&C Act.

Furthermore, the FDA found that Chaga Mountain failed to meet the manufacturing requirements for its dietary supplement products, where the products had “been prepared, packed, or held under conditions that do not meet the Current Good Manufacturing Practice (CGMP) requirements for dietary supplements”.

FDA spokesperson Theresa Eisenman says that any company issued a warning letter must respond in writing within 15 working days of receipt, outlining the specific steps they have taken to identify violations and make corrections to ensure future violations will not occur.

In the past, “most companies have revised their product labeling, which includes the actual products label(s), website and promotional material, to remove the claims that caused the products to be considered unapproved new drugs,”  Eisenman says.

“The FDA will post a close-out letter once the issues raised in the agency’s warning letter have been fully resolved,” Eisenman says.

“We are not able to comment on ongoing investigations.”

Eisenman notes that cosmetic products making drug claims are brought to the FDA’s attention in a number of different ways; however, once products are identified, an evaluation of the claims is performed.  Based on the extent of the claims, the proper enforcement action is then determined.

“When cosmetic companies market products with drug claims but do not provide data on safety and effectiveness for FDA review, we have no way to determine the full scope of risks these products may pose,” Eisenman added.

Chaga Mountain, Inc. had not responded to enquiries from Glammonitor at the time of publication.

Other companies under fire from the FDA in the past have included the USA Far Ocean Group, Avon, Bioque Technologies, Lancome USA, Janson-Beckett and Greek Island Labs.

The Personal Care Products Council (PCPC) says that while it cannot comment on individual enforcement actions, the warning letter issued to Chaga Mountain, Inc. was just one example of the FDA enforcing its regulations.

“It is important to note that there are a number of laws pertaining to the truthfulness of claims made on cosmetic labels and advertising materials,” says Farah Ahmed, associate general counsel and chair of the Marketing Advertising and Claims Committee at the PCPC.

“Many people do not realize how much oversight our regulators have over cosmetic claims – cosmetic claims are regulated by, not one, but two federal agencies (i.e., the FDA, and the Federal Trade Commission (FTC), as well as state consumer protection laws, and they are self-regulated by the industry through the National Advertising Division of the Better Business Bureau,” Ahmed says.

“A cornerstone of the cosmetics industry is research and innovation.  We employ thousands of scientists with a variety of expertise in research and development and our member companies invest heavily in science that powers their products.”

In October 2012, Avon received a warning letter from the FDA, concerning its Anew product line.  The FDA said that, similar to Chaga Mountain, Avon had made claims about its products that qualified them as new drug products, not cosmetics.

“The claims on your website indicate that these products are intended to affect the structure or any function of the human body, rendering them drugs under the Act.  The marketing of these products with claims evidencing these intended uses violates the Act,” the letter stated.

The problem was not in relation to the actual quality or contents of Avon’s products—rather, the advertising suggested that the products fell under the definition of a drug, as outlined by the FD&C Act.

Avon’s advertising for the Anew product line included claims that the cosmetics would “boost collagen production”, “stimulate elastin”, “regenerate hydroproteins” and “boost shock absorbing proteins.”

In response to the FDA’s warning, Avon amended its website and advertising to avoid making any claims that would mislead customers into thinking the product was a drug, not a cosmetic.  Baxam Law Group, a law practice based in Duluth, Georgia, publicly commented on the case, and said that manufacturers needed to be “very careful not to overstep the boundaries of government rules” in marketing their products.

“There must be sound, relevant scientific support to support that advertising claim. And, if you’re a cosmetic maker claiming this product has some therapeutic effect the FDA could decide to require that you seek new drug approval – a lengthy, complex and very expensive process,” the practice says.

“When it comes to advertising statements about cosmetics, sometimes less is more.”

Avon had not responded to Glammonitor’s enquiries at the time of publication.

As Eisenman notes, it is simpler to amend existing labeling and advertising than to register a new drug with the FDA.

But companies that choose to make medical claims about their cosmetic products in the first place risk misleading consumers about their health, with potentially dangerous consequences.

In this regard, less misleading labeling and advertising is definitely more.