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

Public Health Service
Food and Drug Administration

 

5100 Paint Branch Pkwy
College Park, MD 20740-3835

January 4, 2005
WARNING LETTER
VIA OVERNIGHT DELIVERY

Thomas Snee
Ionetics
9991 Goodhue St NE
Blaine, MN 55449

Dear Mr Snee:

This is to advise you that the Food and Drug Administration (FDA) has reviewed labeling for your product "Angioprim" including promotional flyers shipped with product orders and Internet labeling from your websites at http://www.anginacure.com, http://angioprim.com, and http://www.yourticker.com. Based on this labeling, FDA has determined that Angioprim is promoted for conditions that cause the product to be a drug under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 USC 321(g)(1)(B)]. The therapeutic claims in your product labeling establish that the 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 sites include:

Angioprim.com

Angiocure.com and Yourticker.com

All three sites

In addition, the promotional flyers that are sent to customers with Angioprim product contain claims about disease treatment. Examples of such claims include:

Furthermore, your product is not generally recognized as safe and effective for the above referenced conditions and therefore, the product is also a "new drug" under section 201(p) of the Act [21 USC 321(p)]. New Drugs may not be legally marketed in the US without prior approval from FDA as described in section 505(a) of the Act [21 USC 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 letter is not intended to be all-inclusive review of your web site and products your firm markets. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations.

You should take prompt action to correct these deviations and prevent their future recurrence. Failure to do so may result in enforcement action without further notice, such as the seizure of illegal products and injunctions against manufacturers and distributors of those products.

Please advise this office, in writing and within fifteen (15) working days of the receipt of this letter, as to the specific steps you have taken to correct the violations noted above and to assure that similar violations do not occur.

If corrective actions cannot be completed within fifteen working days, state the reason for the delay and the time within the corrections will be completed. Your reply should be addressed to Compliance Officer Kristen L. Moe, 5100 Paint Branch Pkwy, HFS-607, College Park, MD 20740-3835.

Sincerely
/s/
Joseph R. Baca
Director,
Office of Compliance
Center for Food Safety and Applied Nutrition

This page was posted on July 31, 2005.

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