On December 1, 2021, the United States Food and Drug Administration (FDA) sent warning letters to several companies for marketing vaping products with unproven health claims. In a consumer update, the FDA warned consumers that certain “wellness” vaping products containing vitamins or essential oils are sold illegally with unproven claims. Currently, the FDA has not approved any vaping products to prevent or treat any health problems or illnesses.
Based on warning letters sent to a number of companies, the FDA has considered these products to be unapproved drugs that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). Some of these “feel-good” or health claims include enhanced immunity, aid in weight loss, fight against tumors, reduce inflammation, and decrease respiratory infections. Specific examples of the unproven claims of these letters include:
- “Both calming and uplifting, geranium is a natural antidepressant and helps relieve anxiety.”
- “Lychee is a wonderful fruit with many health benefits including its ability to help lose weight, protect the skin, strengthen the immune system, prevent cancer, improve digestion, strengthen bones. , lower blood pressure, defend the body against viruses, improve circulation and optimize metabolic activities.
- “Astragules. . . is known to be a potent herb that strengthens the immune system. . . and can even fight tumors and relieve chemotherapy symptoms! “
- “Ginkgo Biloba (Salisburia adiantifolia).. Widely studied for its anti-inflammatory, antioxidant, platelet and circulation-boosting effects. Current research shows that the benefits of ginkgo include improved cognitive function, positive mood, increased energy , improved memory and reduced symptoms linked to multiple chronic diseases – for example, it has been used as a [sic] biological remedy for asthma, cure for ADHD and treatment of dementia.
The FDA said the companies “should take swift action to remedy the violations cited” in the letter. Additionally, the FDA has said failure to deal with these violations promptly can result in enforcement actions such as seizure and injunction.
Consumers should be careful with vaping products that claim to contain vitamins and other natural ingredients. The terms “wellness” and “natural” on labels are not well defined and are often used to imply product health and safety benefits. Just because a product claims to be natural doesn’t mean it is necessarily safe.
Promotional claims for vaping products can be quite confusing as the products are often labeled as follows:
- food supplements, vitamins, all-natural foods;
- inhalers, infusers, diffusers, vaporizers; and
- wellness vapes or aromatherapy.
The products have been marketed in a variety of flavors and using fancy names to target and attract underage use.
There are very strict requirements for marketing tobacco and nicotine related products in the United States. We expect the FDA to continue its enforcement action against companies that market products with potentially false and misleading claims.