Department of Health and Human Services' logo Department of Health and Human Services

Public Health Service
Food and Drug Administration
New England District Office

 

1 Montvale Ave
Stoneham, MA 02180
Telephone: 781-279-1675
FAX: 781-279-1742

August 6, 1998
WARNING LETTER
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED

Martin Howard, President
Willows General Store, Inc.
70 Faitfield Beach Rd
Westport, CT 06880

Ref. No. NWE-19-98W

Dear Mr Howard:

This letter is in reference to the promotion, marketing, and distribution of products with disease claims. Examples of these products and their claims are:

Based on the claims made for these products, these products are drugs [Section 201(g) of the Food, Drug, and Cosmetics Act (the Act)]. They are also new drugs [Section 201(p) of the Act] and may not be legally marketed in the United States without approved New Drug Applications (§505).

These drugs are also misbranded [§502(f)(1)] because the labeling fails to bear adequate directions for use and the labeling is false and misleading as it suggests that the products are safe and effective for their intended uses when this has not been established [502(a)].

This letter is not intended to be an all inclusive review of all labeling and products your firm markets. It is your responsibility to ensure that all products marketed by your firm are in compliance with the Act and its implementing regulations.

We request that you take prompt action to correct these violations. Failure to promptly correct violations may result in enforcement action being initiated by the Food and Drug Administration without further notice. The Federal Food, Drug and Cosmetic Act provides for the seizure of illegal products and for injunction against the manufacturer and/or distributor of illegal products.

We note that you market additional products also promoted with disease claims. Examples include:

Please notify this office in writing within fifteen (15) working days of receipt of this letter as to the specific steps you have taken to correct the stated violations. You should also include an explanation of each step being taken to identify and make corrections to assure that similar violations will not recur. if corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be implemented.

Your reply should be sent to the Food and Drug Administration, New England District Office; Attention: Bruce R. Ota, Compliance Officer.

Sincerely,
/s/
John R. Marzilli
District Director

This page was posted on August 20, 2006.

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