Frequently Asked Questions
LegitScript maintains the world’s largest comprehensive database of prescription-only drugs, psychoactive highs, problematic dietary supplements, and other regulated healthcare products, organized by legitimacy and safety. LegitScript monitors and catalogs warnings from over 100 government agencies on an on-going basis and follows regulatory developments in nearly 20 countries around the world.
We take a look at two basic questions: First, what is the product, and second, what is the product’s legitimacy or legal status?
As to the first, we look at whether a product is a prescription or OTC drug, controlled substance, unapproved drug, supplement, psychoactive high, or other miscellaneous healthcare product.
As to legitimacy status, products are classified as follows:
- Red Flag. These shouldn’t be sold or marketed at all, either a) globally or b) if designated as “Red Flag” for a specific country, in that country. LegitScript classifies a product as Red Flag if it: (1) contains ingredients that are not permitted or otherwise restricted in certain jurisdictions; (2) is unsafe or has no currently accepted medical use with a high potential for abuse; (3) is tainted with toxins or active pharmaceutical ingredients; (4) is used for psychoactive purposes; or (5) if it intrinsically implies equivalent safety or efficacy of an approved drug or controlled substance. Red Flag products should not be marketed or sold. Psychoactive highs nearly always fall under this category. LegitScript’s database contains more than 25,000 Red Flag products. Examples include: (a) dietary supplements that contain DMAA (1,3-dimethylamylamine); (b) “bath salts” that contain synthetic stimulants; and (c) dietary supplements that contain ginkgo biloba in Ireland.
- Orange Flag. Orange Flag products, when sold without any controls, usually violate our partners’ terms and conditions as well as applicable laws; in limited cases, marketing and sale of an Orange Flag product will be permissible. LegitScript classifies a product as Orange Flag if that product is subject to significant restrictions for online sales. For example, most controlled substances (including prescription-only controlled substances) and discontinued drugs are Orange Flag.
- Yellow Flag. A Yellow Flag designation is NOT a per se bar to marketing or sale of the products. It does mean that some iterations of the product, but not necessarily all, are or have been marketed or formulated in a way that is problematic or illegal. There are three ways that a product gets a Yellow Flag: (1) Illegal (e.g., misleading) claims. The FDA and FTC, and their foreign counterparts, regularly warn or prosecute healthcare merchants marketing products with certain types of claims they consider to be unsupportable or misleading. Of course, that means that the problem isn’t always with the product itself — it’s with the claims. Consequently, a Yellow-Flagged product is not known to contain a toxin or active pharmaceutical ingredient, and there is no per se bar on its sale or marketing. However, the product is, or has been, marketed with claims that drug safety or consumer protection agencies have found to be illegal or misleading. A Yellow Flag is not a bar to advertising or listing a product unless accompanied by the problematic claims. Examples include: (a) supplements marketed as disease treatments; (b) cosmetics marketed to reduce wrinkles; and (c) OTC homeopathic drugs marketed to treat diseases that, according to the FDA, require professional intervention. These products can be marketed if not accompanied by the problematic claims. (2) Product reformulation. A Yellow Flag may also indicate that a manufacturer has reformulated a Red Flag (tainted) product to remove a problematic ingredient, or that an older version of a product contained a Red Flag ingredient. (3) Certain unapproved, but permitted, prescription drugs. LegitScript also classifies certain prescription drugs in the United States as Yellow Flag. In the US, as in most countries, drugs must be FDA-approved or meet an approval exemption. Thus, some prescription-only drugs may be “unapproved” by the FDA, but are still tacitly permitted to be sold. Typically, these products claim to be exempt as either a grandfathered or Drug Efficacy Study Implementation (DESI) drug. Although these are not approved, they are still permitted to be sold in the US, provided that they are sold by a licensed pharmacy pursuant to a valid prescription. LegitScript’s database contains approximately 10,000 Yellow-Flagged products. Learn more about Yellow Flags.
- Green Flag. A Green Flag is reserved for prescription and OTC drugs permitted or approved by an applicable regulatory authority such as the US FDA or Japan’s Ministry of Health, Labor and Welfare.
For Red Flag healthcare products, it is important to note that in most cases, if one country’s drug safety authority determines that a particular supplement or other product contains toxins, active pharmaceutical ingredients, or other dangerous substances, it will be equally problematic in all other countries, not merely in the country whose drug safety agency conducted the testing. For example, suppose that the MHRA (the UK’s medicines agency) determines that a weight loss supplement contains undeclared sibutramine, an active pharmaceutical ingredient that is banned in most countries worldwide, including the US, Japan, and throughout the EU. It would not make sense to permit the product to be marketed into any country, since the MHRA is a credible source of information. Accordingly, many of our Red Flag products are problematic globally.
Yes, in certain circumstances. When a government agency finds undeclared ingredients in a dietary supplement, it is up to the manufacturer to obtain confirmation from the government agency that the concerns regarding the product have been remedied. For example, in the US, it is possible to obtain a “close out letter” from the FDA. Another option is to reformulate the product and make clear on the label that it is a different version than that which had been found to contain the undeclared ingredient.
Yes. If you have reformulated your product to remove problematic ingredients, please submit a new label or other evidence that your product has been reformulated. We will replace the Red Flag with a Yellow Flag, and will warn consumers that a previous version contained an impermissible ingredient.
LegitScript’s process takes jurisdictional considerations into account. For example, yohimbine and ginkgo biloba are considered prescription drugs in some countries but are permissible dietary supplement ingredients in others. Accordingly, we classify products containing those ingredients as Red Flag only in the countries where the ingredients are impermissible.
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:
- 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.
- 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.
- 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.
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.
LegitScript also classifies cosmetics as “Red Flag” or “Yellow Flag” based on similar principles as those we use for supplements.
A cosmetic receives a Red Flag designation if it has been found to: (1) be tainted with toxins (e.g., lead or mercury); (2) contain undeclared active pharmaceutical ingredients (e.g., tretinoin or betamethasone); or (3) contain impermissible levels of certain ingredients (e.g., formaldehyde).
LegitScript classifies a cosmetic as Yellow Flag if it is, or has been, marketed in a way that implies: (1) that it is safe or effective to cure, mitigate, prevent, or treat a medical condition (e.g., “treats rosacea”); or (2) that it can affect the structure or function of the body (e.g., “removes wrinkles”), without having been approved as a drug by applicable regulatory authorities. Learn more about Yellow Flags.
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.
In most other jurisdictions, these same claims are considered misleading, and are therefore unlawful.