Sample Warning Letter for Products Making
Unapproved and Illegal Drug Claims

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

WARNING LETTER

[Firm]
[Address]

Dear [Addressee]:

This is to advise you that the Food and Drug Administration (FDA) has reviewed your web site at the Internet address [URL] and has determined that the product [name of product] is promoted for conditions that cause this product to be a drug under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. §321(g)(1)]. The therapeutic claims on your web site establish that this product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of this product with these claims violates the Act.

Examples of some of the claims observed on your web site include:

[Name of Product]

• [cite specific claims]

Furthermore, these claims are supplemented by the metatags you use to bring consumers to your website. These metatags include [insert meta-tags claim].

Furthermore, your product is not generally recognized as safe and effective for the above referenced conditions and therefore, it is also a "new drug" under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.

This product is also misbranded within the meaning of Section 502(f)(1) of the Act, in that the labeling for this drug fails to bear adequate directions for use [21 U.S.C. § 352(f)(1)].

The above violations are not meant to be an all-inclusive list of deficiencies in your products and their labeling. We noticed that you promoted other products for disease treatment and/or prevention. It is your responsibility to ensure that products marketed by your firm comply with the Act and its implementing regulations. We urge you to review your web site, product labels, and other labeling and promotional materials for your products to ensure that the claims you make for your products do not cause them to violate the Act.

Failure to promptly correct the violations specified above may result in enforcement action without further notice. Enforcement action may include seizure of violative products and/or injunction against the manufacturers and distributors of violative products.

Please advise this office in writing, within 15 working days of receipt of this letter, as to the specific steps you have taken or will be taking to correct these violations, including the steps taken to assure that similar violations do not recur. Include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining deviations.

Your reply should be sent to [insert name], Compliance Officer, Food and Drug Administration, Center for Food Safety and Applied Nutrition, Division of Enforcement (HFS-607), 5100 Paint Branch Parkway, College Park, Maryland 20740-3835.