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

Public Health Service
Food and Drug Administration
Center for Food Safety and Applied Nutrition
Office of Nutritional Products, Labeling, and Dietary Supplements

 

200 C St SW
Washington, DC 20204

May 15, 2000
WARNING LETTER
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED

John Ferolito, President
Ferolito, Vultaggio & Sons, Inc.
5 Dakota Dr #205
Lake Success, NY 11042

Ref. No. ONPLDS 02-00

Dear Mr Ferolito:

The Food and Drug Administration (FDA) has reviewed the label for your "Arizona Rx Stress Relief Elixir." Our review reveals that this label causes the product to be in violation of section 403 of the Federal Food, Drug, and Cosmetic Act (the Act) as follows:

The above violations are not meant to be an alI inclusive list of deficiencies on your product labels. It is your responsibility to assure that all of your products are labeled in compliance with the laws and regulations enforced by FDA. You should take prompt action to correct these deviations and prevent their fiture recurrence. Failure to make prompt corrections could result in regulatory action without further notice. Possible actions include seizure and/or injunction.

We also point out that any ingredient intentionally added to a conventional food such as this beverage or any of your other products must be used in accordance with a food additive regulation, unless it is generally recognized as safe (GRAS) among qualified experts for its intended use. The use of a food ingredient that is neither GRAS nor an approved food additive causes a food to be adulterated under section 402(a)(2)(C) of the Act. You must assure that the ingredients used in your products are either GRAS for their intended use or used in accordance with a food additive regulation.

Please notify this office within 15 working days of receipt of this letter, of the specific steps you have taken or plan to take to correct the noted violations. Copies of revised labels for the products should also be submitted. If corrective actions cannot be completed within 15 working days, state the reason for delay and the time within which corrections will be completed.

You should direct your written reply to me at the Food and Drug Administration, Office of Nutritional Products, Labeling, and Dietary Supplements, 200 C St SW, Washington, DC 20204.

Sincerely yours,
/s/
John B. Foret, Jr.
Director, Division of Compliance and Enforcement

This page was posted on August 20, 2006.

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