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

Public Health Service
Food and Drug Administration
Florida District

 

555 Winderley Pl #200
Maitland, FL 32751

March 25, 2005
WARNING LETTER
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED

Thomas E. Nelson, Owner and Manager
Advantage Nutraceuticals, LLC
906 Skipper Ave
Fort Walton Beach, FL 32547

Ref. No. FLA-05-22

Dear Mr Nelson:

The Food and Drug Administration (FDA) conducted an inspection at your facility at the above address on December 2, 2004. During that inspection, the investigator collected labeling associated with your products, CoralMax™, EllagiMax®, Oxy Plus™, ZanaMax™, Advanced Arthritis Support™ and Fat on Fire. In addition, we reviewed labeling on your website, www.welcometoadvantage.com or www.welcome2advantage.com. A review of this labeling found the products are being offered are promoted for conditions that cause these products to be drugs under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 USC 321(g)(1)]. These claims on your labeling, including your website, establish that these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of these products with these claims violates the Act. You can find the Act and FDA's regulations through links on FDA's Internet home page at www.fda.gov.

The following statements, unless otherwise noted from brochures or product labels, are examples of claims observed in your labeling from your website:

Claims for the ingredients in your product:

Furthermore, these products are not generally recognized as safe and effective for the above referenced conditions and therefore, the products are "new drugs" under section 201(p) of the Act [21 USC 321(p)]. New drugs may not be legally marketed in the United States without prior approval from the 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.

Sunscreen Claims

The following statements are examples of claims observed in your labeling for the product Ellagi Cream related to sun protection:

Claims from website for Ellegic Acid, an ingredient in Ellagi Cream™

Based on this intended use of the product as a sunscreen, the product is a drug as defined by section 201(g) of the Act.

According to the label, this product contains, among other ingredients, "[a] proprietary Blend of Red Raspberry Extract, Octyl Methoxycinnamate, Octyl Salicylate, and it is intended for topical application. We are not aware of a product like Ellagi Cream™, as formulated and labeled, being marketed as a sunscreen product in the US on or before December 4, 1975, so as to qualify for evaluation under FDA's OTC Drug Review, nor are we aware that the red raspberry extract was an active sunscreen ingredient in sunscreen product marketed in the US on or before December 4, 1975. Furthermore, we are not aware that red raspberry extract is generally recognized by scientific experts as safe and effective for use as an ingredient in a sunscreen product. Therefore, Ellagi Cream™ is a "new drug" as defined by section 201(p) of the Act. Since Eliagi Cream™ is not the subject of an approved new drug application, its marketing in the United States violates section 505(a) of the Act.

Registration

The FDA has determined that your facility is subject to the registration requirement in section 415 of the Act [21 USC 350d] and FDA's implementing regulation at 21 CFR Part 1, Subpart H. During our inspection at your facility on December 2, 2004, you were advised of this requirement. Our records indicate that, to date, your facility has not been registered with FDA. The failure to register a facility as required is a prohibited act under section 301(dd) of the Act [21 USC 331(dd)]. Please register your facility immediately. Registration may be accomplished online at www.access.fda.gov. We strongly encourage the use of electronic registration because it will result in an automatic confirmation of registration and automatic issuance of a registration number. Alternatively, you may contact the FDA Industry Systems Help Desk at 1-800-216-7331 or 301-575-0156 to inquiry about mail or fax registration and related forms.

This letter is not an all-inclusive review of your websites, facility, and the products that your firm markets. It is your responsibility to ensure that all products marketed by your firm and your firm's facilities comply with the Act and its implementing regulations.

The Act authorizes the seizure of illegal products and injunctions against the manufacturers and distributors of those products [21 USC 332 and 334]. You should take prompt action to correct any violations identified in this letter. Failure to do so may result in enforcement action without further notice.

Please advise this office, in writing and within fifteen (15) working days of receipt of this letter, as to the specific steps that you have taken to correct any violations and to assure that similar violations do not occur. If corrective action cannot be completed with fifteen working days, state the reason for the delay and the time within which the corrections will be made.

Your reply should be addressed to Shari H. Shambaugh, Compliance Officer, US Food and Drug Administration, 555 Winderley Pl #200, Maitland, FL 32751.

Sincerely,
/s/
Emma K. Singleton
District Director

This page was posted on March 28, 2006.

Links to Recommended Companies