| Public Health Service Food and Drug Administration |
| 555 Windertey Pl., Ste. 200 Maitland, FL 327514 |
Department of Health and Human ServicesCERTIFIED MAIL
RETURN RECEIPT REQUESTED
WARNING LETTER
FLA-10-21
May 25, 2010
Ms. Simpson
FLexcin International
4085 Hancock Bridge Parkway Suite 111
Fort Myers, FL 33903
Dear Ms. Simpson:
This is to advise you that the Food and Drug Administration (FDA) has reviewed your website at the Internet address www.flexcin.com and has determined that the products "Flexin with CM8™,'' "Cal-Flex Calcium Pure" and "Flexpet" are promoted for conditions that cause the products to be drugs under section 201(g)(1)(B} of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims on your website establish that the products are drugs because they are intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in humans or animals. The marketing of the products with these claims violates the Act. Additionally, "Flexin with CM8™'' and "Cal-Flex Calcium" are new drugs under section 201(p) of the Act [21 U.S.C. § 321(p)], because they are intended for use in humans and they are not generally recognized as safe and effective for their intended uses. Similarly, "Flexpets" is a new animal drug under section 201(v) of the Act [21 U.S.C. § 321(v)], because it is intended for use in animals and FDA is not aware of any scientific evidence showing the product is generally recognized as safe and effective for its intended uses. You may find the Act and the FDA's regulations through links in the FDA's home page at www.fda.gov.
New Drugs
Some examples of statements on your website that establish these intended uses for your products include the following:
Flexin with CM8â„¢
Under your "Home" page tab:
• "Joint Pain Remedy Treatment-Flexcin with CM8™''
• "Joint Pain, Arthritis, Gout & Fibromyalgia are eliminated with Flexcin w/CM8™''
• "Are you in constant need of joint pain relief? Arthritis, Gout, Rheumatoid Arthritis,
Bursitis, Fibromyalgia, and any other form of joint pain becomes a "thing of the past" once you have tried Flexcin with CM8â„¢"
Under your "What is Flexcin?" tab:
• "When we dispense Flexcin to patients we ask for their complete cooperation for a minimum of 60 days as a trial period, in most cases this is sufficient time for the patient to see an improvement in their joint function. However, it is not unusual for a patient to return to my office and report a decrease in joint pain and stiffness within two or three weeks."
• "Flexcin has been proven to be an effective pain reliever for:
o Rheumatoid Arthritis
o Gout
o Fibromyalgia
o Osteoarthritis
o Bursitis ..."
In addition, at the bottom of your website, there are links to " Rheumatoid Arthritis Pain Relief," "Gout Pain Relief," "Fibromyalgia Pain Relief," "Osteoarthritis Pain Relief," "Bursitis Pain Relief," and "Arthritis Pain Relief."
Under the Rheumatoid Arthritis Pain Relief link:
• "Of all the ingredients in Flexin, CM8™ is the most powerful anti-inflammatory agent available today."
Under the Gout Pain Relief link:
• "Effective Gout Treatment - Flexcin w/CM8™''
• "The most effective gout treatment on the market today is Flexcin with CM8™''
• "Gout Joint Pain CAN BE STOPPED FOREVER! Flexcin™ with CM8™ is a NEW generation of gout joint pain relief... "
Under the Fibromyalgia Pain Relief link:
• "Fibromyalgia Pain Treatment with Flexcin is your best choice"
• "Flexcin is treating thousands of everyday people just like you to Fibromyalgia relief."
Under the Osteoarthritis Pain Relief link:
• "Effective Osteoarthritis Pain relief Flexin with CM8!"
• "STOP the pain in your joints caused by Osteoarthritis using Flexcin with CM8."
• "Let Flexcin rid you of your osteo aches ... "
• "Make Osteoarthritis Joint Pain A Thing Of The Past The Flexcin Way!"
Under the Bursitis Pain Relief link:
• "Flexcin: Your Best Choice for Bursitis Joint Pain Relief."
• "Thousands of people are living life without the joint pain caused by Bursitis, thanks to
Flexcin."
• "[F]lexcin has been shown to ... decrease joint pain dramatically."
• "The key ingredient in Flexcin is CM8. Of all the ingredients in Flexcin, CM8 is the most powerful anti-inflammatory agent available today."
Under the Arthritis Pain Relief link:
• "Flexcin: Your Best Choice for Arthritis Joint Pain!"
• "The key ingredient in Flexcin is CM8. Of all the ingredients in Flexcin, CM8 is the most powerful anti-inflammatory agent available today... [w]ith this powerful ingredient you will be able to live life without the pains you are experiencing from Arthritis, guaranteed!"
• (testimonial) "I was using canes and] didn't want to have a knee replacement. ] started taking Flexcin and with in (sic) 3-6 weeks] started noticing less and less pain and] was walking better."
Cal-Flex Calcium Pure
• "Studies have shown that mineral deficiencies such as calcium can lead to many diseases such as osteoporosis and cancer. 1000mg a day of our pure calcium CalFlex....prevent[s] degenerative disease."
Under your "Success Stories" tab:
• (testimonials) "I have degenerative arthritis in back; I have a lot of back pain. I listen to Duke and The Doctor off and on, and they had advertised Flexcin and some of the testimonials that they were giving sounded like it was a very good deal. Flexcin has changed my life in the sense that I don't experience the back pain every morning I get up."
New drugs such as your Flexin with CM8 and Cal-Flex Calcium Pure products may not be legally marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act [21 U.S.c. § 355(a)]. FDA approves new drugs on the basis of scientific data submitted
by a drug sponsor to demonstrate that the drug is safe and effective. Your Flexcin and Cal-Flex Calcium Pure" products are also misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352 (f)(1)] in that the labeling for these drugs fails to bear adequate directions for use.
New Animal Drug
Some examples of statements on your website that establish these intended uses for your products include, but are not limited to, the following:
• "Flexpet will relieve pain caused by Dog Arthritis, Cat Arthritis, and all forms of arthritis that affect your pets."
• "Clinically Proven to Promote Healthier Joints in your pets."
• Testimonial: "That was the beginning of her disc problem in her back. As she got older it was painful to me to see her walk - all scrunched over and obviously in pain. She was 12 by the time I heard about Flexpet but I started her on it and in a very short time she was going on short little walks with me and looking for her dog biscuits again. (She had no appetite when her back was hurting.) Her last two years of life she was pain free and I have Flexpet to thank. "
These statements are supplemented by metatag keywords that you use to direct consumers to your web site through Internet searches. The metatag keywords include:
• Flexpet will relieve your dog's arthritis, cat 's arthritis and is great for all pets. It's been proven effective against, all forms of dog arthritis. It's most effective dog arthritis treatment today.
• Dog arthritis, dog arthritis medication, dog arthritis medicine, cat arthritis, arthritis medication for dogs, joint pain relief, muscle pain relief, arthritis in dog, pet pain reliever, dog arthritis treatment, horse arthritis, horse arthritis formula.
Under section 512(a) of the Act [21 U.S.C. § 360b(a)] "Flexpet" is unsafe because it is not the subject of a 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)], Conditional Approval under section 571 of the Act [21 U.S.C. § 360ccc], or Index Listing under section 572 of the Act [21 U.S.C. § 360ccc-l]. As such, this product 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 any adulterated drug into interstate commerce. Your sale of "Flexpet" without an approved NADA violates the law.
The violations mentioned above are not intended to be an all-inclusive list of violations. 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 the violations described above and prevent their further recurrence. Failure to do so may result in enforcement action without further notice. The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products [21 U.S.C. §§ 332 and 334].
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct the violations noted above. You should include in your response, documentation and any other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
Please send your reply to the Food and Drug Administration, Attention: Carla A. Norris, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida, 32751. If you have questions regarding any issues in this letter, please contact Ms. Norris at (407) 475-4730.
Sincerely,
/s/
Emma R. Singleton
Director, Florida District
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