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

Public Health Service
Food and Drug Administration
Central Region
Detroit District Office

 

1560 E Jefferson Ave
Detroit, Ml 48207-3179
Telephone: 313-226-6260
FAX: 313-226-3076

June 7, 1999
WARNING LETTER
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED

Margaret M. Burco, President
Nature's Vision, Inc.
7320 Garden Ln
Portage, MI 49002

Ref. No. 99-DT-09

Dear Ms Burco:

This letter is in reference to your firm's marketing and distribution of unapproved new drugs.

Promotional materials, including your product catalogs, are labeling. These catalogs makes therapeutic claims for your products which cause the products to be drugs as defined in Section 201(g) of the Federal Food, Drug, and Cosmetic Act (the Act).

Examples of claims appearing in your most recent product catalogs include the following:

These products are "new drugs" because there is no evidence that they are generally recognized as safe and effective for their intended uses [Section 201(p) of the Act]. Therefore, they may not be legally marketed in this country without approved New Drug Applications [section 505(a) of the Act].

The drugs are also misbranded because their labeling fails to bear adequate directions for the conditions for which they are offered [Section 502(i)(1) of the Act]. The labeling is false and misleading as it suggests that the products are safe and effective for their intended uses when, in fact, this has not been established [Section 502(a) of the Act].

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 conect these violations. Failure to promptly correct these 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 an injunction against the manufacturer and/or distributor of illegal products.

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, including an explanation of each step being taken to identify and make corrections to assure that similar violations will not occur. 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 directed to Sandra Williams, Compliance Officer, at the above address.

Sincerely,
/s/
Raymond V. Mlecko
District Director

This page was posted on August 20, 2006.

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