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Public Health Service
Food and Drug Administration
  555 Winderley PI., Ste. 200
Maitland, FI . 32751

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

FLA-09-19

July 30, 2009

J. Roy Rogers, President
Synflex America, Inc.
5358 Gulf Drive
Holmes Beach, Florida 34217

WARNING LETTER

Dear Mr. Rogers:

This letter concerns your firm's marketing of "Synflex Original Formula," "Synflex 1500," "Synflex for Athletes," and "Synflex for Pets." Based on statements made on your web site at the Internet address www.synflexamerica.com these products are drugs under section 201(g)(I)(B) and (C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(I)(B) and (C)), because these products are intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in humans or animals, and because they are intended to affect the structure or function of the body of man or other animals. Additionally, "Synflex Original Formula," "Synflex 1500," and "Synflex for Athletes" are new drugs within the meaning of section 201(P) of the Act [21 U.S.C. § 321(p)), and "Synflex for Pets" is a new animal drug under section 201(v) of the Act [21 U.S.C. § 321(v)), because they are not generally recognized, by qualified experts, as safe and effective for their labeled uses.

Some examples of statements on your web site that establish these intended uses for your product include, but are not limited to, the following statements:

Synflex Original Formula

Synflex 1500

Synflex for Athletes

Synflex for Pets

These statements are supplemented by metatag keywords that you use to direct consumers to your web site through Internet searches. The metatag: keywords include "arthritis," "arthritis pain relief," "arthritis pain relief in people," "arthritis in dogs," "pet arthritis in dogs," "feline arthritis," "rheumatoid arthritis," "relieve pain," "pain relief," "pain," "joint pain," and "joint pain relief."

Your "Synflex Original Formula," "Synflex 1500," "Synflex for Athletes," and "Synflex for Pets" are drugs as defined by section 201(g)(I)(B) of the Act [21 U.S.C. § 321(g)(I)(B)], because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and under section 201(g)(1)(C) of the Act [21 U.S.C. § 321(g)(I)(C)], because they are intended to affect the structure or function of the body of man or other animals.

Moreover, "Synflex Original Formula," "Synflex 1500," and "Synflex for Athletes" are new drugs within the meaning of section 201(p) of the Act [21 U.S.C. §321(P)], because they are not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof [21 U.S.C. § 321(p)]. Under section 505(a) of the Act [21 U.S.C. § 355(a)] a new drug may not be introduced or delivered for introduction into interstate commerce unless it is subject to an FDA-approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). These products intended for use in humans do not have approved applications and their introduction or delivery for introduction into interstate commerce violates section 301(d) of the Act [21 U.S.C. § 331(d)]. Your distribution of "Synflex Original Formula," "Synflex 1500," and "Synflex for Athletes" violates the law.

In addition, your "Synflex for Pets" is a new animal drug under section'201(v) of the Act [21 U.S.C. § 321(v)], because it is "not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs,as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof [21 U.S.C. § 321(v)]. Under section 512(a) of the Act [21 U.S.C. § 360b(a)] "Synflex for Pets" is unsafe because it is not the subject of an approved New Animal Drug Application (NADA) or Abbreviated New Animal Drug Application (ANADA) under section 512(b) of the Act [21 U.S.C. § 360b(b)], a Conditional Approval under section 571 of the Act [21 U.S.C. § 360ccc], or an Index Listing under section 572 of the Act [21 U.S.C. § 360ccc-1]. As such, it is adulterated under section 501(a)(5) of the Act [21 U.S.C. § 351(a)(5)]. Under section 301(a) of the Act [21 U.S.C. § 331(a)], it is unlawful to introduce or deliver for introduction any adulterated drug into interstate commerce. Your sale of "Synflex for Pets" without an approved application or index listing violates the law. 

The issues and violations mentioned above are not intended to be an all-inclusive list of violations that exist with respect to your marketing of new drugs and new animal drugs. You are responsible for investigating and for preventing recurrence of these, or other violations, to ensure that you comply with all requirements of federal law and FDA regulations.

You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, such as seizure and/or injunction.

Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct these violations. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.

Your written response should be sent to Jimmy E. Walthall, Director, Compliance Branch, Florida District, Food and Drug Administration, 555 Winderley Place, Ste. 200, Maitland, FL 32751. If you have any questions about this letter, please contact Mr. Walthall at (407) 475-4734. 

Sincerely,

/S/

Emma R. Singleton
Director, Florida District

This page was posted on January 31, 2010.

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