Has a product you are marketing or selling received a “Yellow Flag” designation?
We don’t remove Yellow Flag designations from products, but the mere presence of a Yellow Flag shouldn’t prevent you from marketing or selling your product.
Below are examples of common problematic claims. If you or your marketers are making claims like this about your products, we encourage you to remove them.
Examples of Common Problematic Claims
Claims that a Dietary Supplement Can Cure Cancer
Dietary supplements cannot be marketed with claims to cure, mitigate, prevent, or treat a disease, including cancer. The FDA has warned consumers of “bogus remedies” claiming to cure cancer. These claims include phrases such as:
- “Treats all forms of cancer”
- “Miraculously kills cancer cells and tumors”
- “Shrinks malignant tumors”
- “Selectively kills cancer cells”
- “More effective than chemotherapy”
- “Attacks cancer cells, leaving healthy cells intact”
If a dietary supplement is marketed with claims to treat cancer — or any other disease — it likely will be Yellow-Flagged.
Weight Loss Claims
In the US, dietary supplements can make structure/function claims so long as the claim has adequate substantiation that it is truthful and not misleading. The Federal Trade Commission has compiled 7 “gut check” claims (i.e., claims related to substantial weight loss) that are false and misleading. Examples include claims that a product:
- Causes weight loss of two pounds or more a week for a month or more without dieting or exercise.
- Causes substantial weight loss no matter what or how much the consumer eats.
- Safely enables consumers to lose more than three pounds per week for more than four weeks.
- Causes substantial weight loss for all users.
The FTC also notes that “gut check” claims can be “conveyed in more subtle ways” and that “some advertisers are careful not to use the exact wording of ‘gut check’ claims.” Dietary supplements marketed with any FTC “gut check” claims for weight loss may be Yellow-Flagged.
Cosmetics and Claims to Reduce Wrinkles, Boost Collagen, or Make Eyelashes Grow
In the US, claims that a topical product affects the structure or function of the body cause that product to be considered a drug under the Federal Food, Drug, and Cosmetic Act. If a product is marketed as a drug (by making drug claims), it must comply with all applicable drug laws, including (where necessary) obtaining premarket approval by the FDA before being sold. A cosmetic marketed with the following claims may cause the product to be considered a drug:
- “Reduces cellulite”
- “Treats varicose veins”
- “Increases or decreases the production of melanin (pigment) in the skin”
- “Regenerates cells”
- “Boosts collagen”
- “Reduces wrinkles”
- “Restores hair growth”
A cosmetic being marketed with one or more drug claims, such as the ones listed above, may be Yellow-Flagged. Also refer to FDA guidance on cosmetics and drugs.
In most jurisdictions, the claims described above are considered misleading, and are therefore unlawful.