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.
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:
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:
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:
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.
No, not merely by virtue of being Yellow-Flagged. LegitScript’s Yellow Flag classification does not suggest that a product should always be prohibited from advertising, nor does it suggest that the product is intrinsically harmful or dangerous in all cases. It instead means that advertising platforms, e-commerce platforms, and banks should scrutinize these products more carefully, and there are some contexts in which the product cannot be advertised or sold.
Typically, there are three common reasons for a Yellow Flag designation:
No. Products are included in our database when they are currently, or have been previously, impermissibly marketed with problematic claims, have been reformulated, or are unapproved by the FDA but are approved by virtue of being grandfathered or a “DESI” drug.
If the Yellow Flag was based on problematic claims, after you have fully removed all problematic claims from your website and advertisements, we suggest that you contact your advertising account representative to let him or her know that you have brought your website and marketing into compliance. Your account representative may then re-review your website for compliance.