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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Synflex America Inc 7/30/09

   

Department of Health and Human Services' logoDepartment of Health and Human Services

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

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

WARNING LETTER
FLA-09-19

July 30, 2009

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

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

• "Our original formula and one of the most effective osteoarthritis...products on the market."

• "A high quality liquid Glucosamine formula and one of the most effective osteoarthritis...health care products on the market today... "

• "Synflex ® is a breakthrough product in the world of osteoarthritis, joint pain, and cartilage degeneration."

• "Ease articular joint pain"

• "Assists in rebuilding and rehabilitating damage cartilage"

• "Reduce inflammation"

•"Glucosamine and ten other synergistIc arthritis fighting ingredients like chondroitin, boswellin, bromelain, yucca, omega 3 and omega 6 fatty acids to name a few."

• "Even in the most severe and advanced cases of osteoarthritis,' the large majority of our users report significant improvement within 20-25 days. Even better, Synflex ® has no serious side effects unlike Cox-II Inhibitors, Vioxx and Celebrex." 

Synflex 1500

• "But for those who want more glucosamine and added pain relief, try Syn-flex 1500 with white willow bark."

• "White Willow Bark contains an ingredient called Salicin. When introduced into your body, it becomes salicylic acid. In an arthritis product, it provides one more anti-inflammatory to the formula. As well, it helps reduce prostaglandins which cause pain and inflammation." 

Synflex for Athletes

• "Assists in rehabilitating damaged cartilage"

• "Improves mobility and reduces inflammation"

• "Is a premium quality liquid glucosamine for ...rapid pain relief':

Synflex for Pets

• "for arthritis in pets."

• "Liquid glucosamine is clinically proven to be highly beneficial in the treatment of osteoarthritis and hip dysplasia in pets."

• "... significant pain relief in just a matter of ten to fourteen days, sometimes sooner." 

• "Synflex for Pets has been reported to show significant improvement within 2025 days even in the most severe cases of osteoarthritis."

• " ... to effectively manage osteoarthritis, aid in rehabilitating damaged cartilage, promote healthy joints, and reduce inflammation."

• " ... can significantly reduce arthritis pain ... "

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