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CFSAN/Office of Compliance
October 17, 2005
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
[firm]
[address]
Dear [addressee]:
The Food and Drug Administration (FDA) has reviewed the labeling of your [name of product] on your web site at [URL]. This review shows serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) in the labeling of this product. You can find the Act and implementing regulations through links on FDA's Internet home page at www.fda.gov.
Under the Act, articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man are drugs [Section 201(g)(1)(B) of the Act]. The labeling for your product [name of product] bears the following claims:
[cite specific claims]
This list of claims is not intended to be all-inclusive, but represents the types of claims found in your product labeling.
These claims cause your product to be a drug, as defined in section 201(g)(1)(B) of the Act. Because this product is not generally recognized as safe and effective when used as labeled, it is also a new drug as defined in section 201(p) of the Act. Under section 505 of the Act, a new drug may not be legally marketed in the United States without an approved New Drug Application (NDA). 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.
The above violations are not meant to be an all-inclusive list of deficiencies in your products and their labeling. It is your responsibility to ensure that products marketed by your firm comply with the Act and its implementing regulations.
Failure to promptly correct these violations may result in enforcement action without further notice. Enforcement action may include seizure of violative products, injunction against the manufacturers and distributors of violative products, and criminal sanctions against persons responsible for causing violations of the Act.
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. Your reply should be directed to [compliance officer] at [address].
[name]
List of Firms Receiving Warning Letters Regarding Cherry and other Fruit-Based Products with Disease Claims in Labeling October 17, 2005
