LegitScript Yellow Flag Product Claims

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.

Frequently Asked Questions

I am an advertiser and I’ve been told my product has been Yellow-Flagged by LegitScript. Will the Yellow Flag prevent me from advertising?

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:

  1. The most common reason is that the product is, or has been, marketed with problematic claims that may trigger regulatory scrutiny (e.g., those that the FDA or FTC, or their foreign counterparts, consider to be misleading). In the absence of such claims, Yellow Flag products should be allowed to advertise.
  2. A product may also receive a Yellow Flag designation if it was reformulated after having been found to be tainted with toxins or banned substances (in which case it would have received a Red Flag designation). After reformulation, it may be difficult for resellers and customers to determine whether a product is formulated with the old (illegally tainted) version or the new (reformulated) one, so the product may receive a Yellow Flag to elicit caution.
  3. A product may be Yellow-Flagged if it is technically unapproved by the FDA, but nevertheless permitted because it’s grandfathered or a Drug Efficacy Study Implementation (DESI) drug. In short, Yellow Flag, as the color suggests, indicates that one should pause and take a close look at the context and other factors. In the absence of problematic factors, you should not encounter any problems marketing your product.
Does LegitScript remove Yellow Flags?

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.

I have removed problematic claims from my website. Why am I still having problems advertising?

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.