Cosmetics Companies Under Fire

Cosmetics companies are under fire for advertising drug claims for their products.

The US Food and Drug Administration (FDA) has sent warning letters to Earthworks Health and Green Water, LLC, because these companies were making drug claims about their products.

Under the Federal Food, Drug, and Cosmetic Act, a drug is classified as a product intended to diagnose, mitigate, treat, or prevent disease or to affect the structure or function of the body. Drugs must be approved by the FDA. Although Earthworks Health and Green Water, LLC, were making health and drug-related claims about their products, these items had not been evaluated for safety or efficacy, nor had they been approved under a New Drug Application.

Over the last 12 years, the FDA has sent 77 warning letters to 71 companies for products that fall under skin care preparations, hair products, and eyelash and eyebrow treatments.

These companies have claimed that their products treat acne and rosacea, reduce cellulite, promote collagen to reduce wrinkles, promote wound healing, restore hair and much more. These claims have been found on product labeling and companies' websites.

Some other companies that have come under fire in recent years include Avon Products, Inc., StriVectin Operating Company, L’Oréal USA and Skin Biology, Inc.

As for the FDA's recent warning to Earthworks Health, this company's product called 100% Food Grade Diatomaceous Earth (DE) claimed the following on YouTube, according to the FDA:

• "Great for connective tissue disorders, pain, and sleep issues”
• “Removes Toxins From The Gut”

Several of Green Water, LLC's products, such as Headache Ease Tincture and Migraine Relief, claimed to help headaches and migraines, respectively. The company's Restore & Revive PLUS Cream claimed to help with skin conditions like eczema, psoriasis, and burns and wounds.

Speak to your local pharmacist if you have any questions about a product that makes health claims.

Written by Anyssa Garza, PharmD, BCMAS