| Public Health Service Food and Drug Administration |
| Cincinnati District Office 6751 Steger Dr. Cincinnati, OH 45237 Telephone: (513) 679-2700 FAX: (513) 679-2771 |
Department of Health and Human Services
Via United Parcel Service
WARNING LETTER CIN-10-89724-10
May 12, 2010
James D. Smith, Jr.
CEO and General Manager
Cogent Solutions Group, L.L.C.
P.O. Box 11686
Lexington, Kentucky 40577
Dear Mr. Smith:
This letter concerns your firm's marketing of "Runovia," "Trixsyn," and "Hyaluronex." An inspection of your facility located at 2339 Sandersville Rd., Lexington, Kentucky was conducted on November 6, 9 and 10, 2009. The inspection found that your firm labels and distributes products for both animal and human consumption. Our review of your product labels, labeling and internet sites, www.runovia.com. www.trixsyn.com, www.hyaluronex.com, and www.congentsolutionsgroup.com, reveals that your products, "Runovia", "Trixsyn", and "Hyaluronex" are 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)] because they bear therapeutic claims that establish that the products are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or animals. The marketing of these products with these claims violates the Act.
New Drug
Examples of some of the claims observed on your website at the Internet address www.runovia.com include the following:
• " ... Runovia delivers hyaluronan - the key molecule for joint health ... The link between hyaluronan and performance was first observed in equine athletes - where joint problems can be not only painful, but also deadly - and has more recently been established in humans. It was also found that strenuous training could be resumed more quickly with oral hyaluronan supplementation, and that dependence on anti-inflammatory medications was reduced ... Douglas W. Kiburz, M.D., orthopedic surgeon, performed a clinical study confirming these observations in humans."
• "The key ingredient in Cogent's product line is hyaluronan, a molecule whose physiological role includes the lubrication and cushioning of joints along with the control of pain and inflammation. Runovia™ features a polydisperse molecular weight range of hyaluronan ... "
• "Hyaluronan is broken down by repetitive motion and trauma - the hallmarks of intense training. The resulting smaller fragments of hyaluronan tend to promote inflammation. During recovery periods, newly-synthesized, larger molecules of hyaluronan keep inflammation in check. Oral supplementation with hyaluronan also keeps inflammation in check."
• "Supplementation with hyaluronan thus can stimulate the body to increase the production of its own hyaluronan in the tissues where it is most sorely needed to stave off inflammation and longer-term consequences such as osteoarthritis."
Your Runovia product is not generally recognized as safe and effective for the above referenced uses and therefore, it is a "new drug" under section 201(p) of the Act [21 U.S.C. §321(p)]. New drugs 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 a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.
New Animal Drugs
Some examples of statements on your labels and applicable web sites that establish these intended uses for your products include, but are not limited to the following:
Product bottle labels:
• "Hyaluronex" and "Trixsyn" labeling states that hyaluronex helps replenish hyaluronan due to trauma and osteoarthritis which reduces joint pain, controls inflammation, protects cartilage and hydrates tissues.
Cogent Solutions website - www.cogentsolutionsgroup.com:
• MHB3 hyaluronan, the key ingredient in "Hyaluronex" and "Trixsyn", has been proven in preclinical and clinical studies to protect joints and fight arthritis. Replenishing hyaluronan controls inflammation, reduces joint pain and stabilizes vertebrae. For instance, one study found the effect of MHB3 to be dramatic by relieving joint pain and inflammation.
Trixsyn Joint Supplement website - www.trixsyn.com:
• Recent laboratory and clinical study results show that MHB3, the active ingredient in Trixsyn, is the first oral joint supplement ingredient proven to protect joints and fight arthritis.
• Studies show that orally administered MHB3 can interrupt inflammatory processes, modify the course of disease progression, and relieve the symptoms of osteoarthritis and chronic joint pain.
• With millions of Americans, their pets, and horses suffering from osteoarthritis and the news that glucosamine and chondroitin sulfate are ineffective, what options do consumers have? A collaboration of researchers from Kentucky, Missouri, and Ontario, Canada have the answer: a new and effective dietary supplement ingredient called MHB3, a special hyaluronan biopolymer that is taken orally. Pre-clinical and clinical studies indicate MHB3 is the first supplement ingredient actually proven to protect joints and fight arthritis.
• MHB3 helps replenish the natural hyaluronan in the body which: reduces joint pain, controls inflammation, protects cartilage, hydrates tissues, lubricates joints, and stabilizes vertebrae.
• In a human clinical trial of MHB3, Douglas W. Kiburz, M.D., FAOOS, West Central Missouri Orthopedics, used the biopolymer orally with 50 subjects suffering from Chronic Joint Symptoms for one month. "I spend most of my professional time helping people deal with joint pain and inflammation by prescribing drugs, injecting joints and in the worst cases replacing joints entirely. Because we just can't inject or replace every joint that aches, the idea of systemically supporting cartilage had tremendous appeal to me and my patients." Dr. Kiburz said. "We conducted an open label study to assess its effectiveness with people. Over 80% of study participants reported good to excellent results." The surgeon continued, "With results like that, MHB3 based products will make glucosamine and other joint supplements obsolete." The clinical trial also concluded that the use of MHB3 is safe, there having been no side effects, drug interactions or contra-indications.
• Specifically, only MHB3 hyaluronan has demonstrated symptom relief, chondro-protection, and disease modification in placebo controlled studies.
• Trixsyn is an effective and convenient way to: Improve joint mobility by alleviating pain and reducing inflammation; Promote the repair, maintenance, and protection of cartilage and joint tissues; Stimulate bone formation by increasing bone mineral density; and, Support tissue health and function in the lining of the stomach, intestines, and bladder.
• In a chondro-protection study the effect of Trixsyn's MHB3 formulation was dramatic, preventing the progression of osteoarthritis into articular cartilage and preventing the formation of osteophytes (bone spurs) as well.
• In a recent bone loss study the effect of oral MHB3 (modified hyaluronan) supplementation on bone loss were investigated and found that MHB3 significantly reduces the development of osteopenia associated with estrogen depletion.
• In a disease modification study the benefits of Trixsyn' s MHB3 were evaluated against existing osteoarthritis where it proved to have disease modifying benefits.
• In a Chronic Joint Symptoms study the effect of Trixsyn's MHB3 formulation relieves joint pain and inflammation contributing to an improved range of motion and an increase in daily activity among the majority of subjects.
• Trixsyn with MHB3 can help alleviate the pain many animals experience, while simultaneously reducing inflammation, protecting cartilage, and improving existing synovial fluid.
Hyaluronex Web Site - www.hyaluronex.com
• Recent laboratory and clinical study results show that MHB3, the active ingredient in Hyaluronex, is the first oral joint supplement ingredient proven to protect joints and fight arthritis.
• Studies show that orally administered MHB3 can interrupt inflammatory processes, modify the course of disease progression, and relieve the symptoms of osteoarthritis and chronic joint pain.
• With millions of Americans, their pets, and horses suffering from osteoarthritis and the news that glucosamine and chondroitin sulfate are ineffective, what options do consumers have? A collaboration of researchers from Kentucky, Missouri, and Ontario, Canada have the answer: a new and effective dietary supplement ingredient called MHB3, a special hyaluronan biopolymer that is taken orally. Pre-clinical and clinical studies indicate MHB3 is the first supplement ingredient actually proven to protect joints and fight arthritis.
• MHB3 helps replenish the natural hyaluronan in the body which: reduces joint pain, controls inflammation, protects cartilage, hydrates tissues, lubricates joints, and stabilizes vertebrae.
• In a human clinical trial of MHB3, Douglas W. Kiburz, M.D., FAOOS, West Central Missouri Orthopedics, used the biopolymer orally with 50 subjects suffering from Chronic Joint Symptoms for one month. "I spend most of my professional time helping people deal with joint pain and inflammation by prescribing drugs, injecting joints and in the worst cases replacing joints entirely. Because we just can't inject or replace every joint that aches, the idea of systemically supporting cartilage had tremendous appeal to me and my patients." Dr. Kiburz said. "We conducted an open label study to assess its effectiveness with people. Over 80% of study participants reported good to excellent results." The surgeon continued, "With results like that, MHB3 based products will make glucosamine and other joint supplements obsolete." The clinical trial also concluded that the use of MHB3 is safe, there having been no side effects, drug interactions or contra-indications.
• Specifically, only MHB3 hyaluronan has demonstrated symptom relief, chondro-protection, and disease modification in placebo controlled studies.
• Hyaluronex is an effective and convenient way to: Improve joint mobility by alleviating pain and reducing inflammation; Promote the repair, maintenance, and protection of cartilage and joint tissues; Stimulate bone formation by increasing bone mineral density; and, Support tissue health and function in the lining of the stomach, intestines, and bladder.
• In a chondro-protection study the effect of Hyaluronex's MHB3 formulation was dramatic, preventing the progression of osteoarthritis into articular cartilage and preventing the formation of osteophytes (bone spurs) as well.
• In a recent bone loss study the effect of oral MHB3 (modified hyaluronan) supplementation on bone loss were investigated and found that MHB3 significantly reduces the development of osteopenia associated with estrogen depletion.
• In a disease modification study the benefits of Hyaluronex's MHB3 were evaluated against existing osteoarthritis where it proved to have disease modifying benefits.
• In a Chronic Joint Symptoms study the effect of Hyaluronex's MHB3 formulation relieves joint pain and inflammation contributing to an improved range of motion and an increase in daily activity among the majority of subjects.
• Hyaluronex with MHB3 can help alleviate the pain many animals experience, while simultaneously reducing inflammation, protecting cartilage, and improving existing synovial fluid.
The labeling and web site claims for "Trixsyn" and "Hyaluronex" establish the fact that these products are intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in animals. These products are therefore drugs under section 201 (g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)]. The products are also new animal drugs under section 201(v) of the Act [21 U.S.C. § 321(v)] because FDA is not aware of any scientific evidence showing the products are "generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof."
Under section 512(a) of the Act [21 U.S.C. § 360b(a)] "Trixsyn" and "Hyaluronex" are unsafe because they are not the subjects ofNew Animal Drug Applications (NADAs) or Abbreviated New Animal Drug Applications (ANADAs) under section 512(b) of the Act [21 U.S.C. § 360b(b)], Conditional Approvals under section 571 of the Act [21 U.S.C. § 360ccc], or Index Listings under section 572 of the Act [21 U.S.C. § 360ccc-1]. As such, these products are 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 "Trixsyn" and "Hyaluronex" without approved NADAs violates the law.
Dietary Supplement
Even if your Runovia product did not contain disease claims in its labeling that cause it to be a drug, it would still be a misbranded dietary supplement. Your product, Runovia, intended for human use, is misbranded within the meaning of sections 403(i)(1) and 403 (s)(2)(B) of the Act [21 U.S.C. §§ 343(i)(1) and 343(s)(2)(B)] because the label fails to identify the product using the term "dietary supplement" as part of the statement of identity on the principal display panel, as required by 21 CFR 101.3(a) and (g).
Runovia is also misbranded under section 403(q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] in that the nutrition information on its product label does not comply with certain requirements under 21 CFR 101.36. Examples of the deviations from the requirements of 21 CFR 101.36 include:
• You must set information within the nutrition label on intermediate-sized packages in type size no smaller than 6 point, as required by 21 CFR 101.36(i)(2)(ii). However, the information within the nutrition label on the intermediate-sized package for your Runovia product is in a type size smaller than 6 point.
• The title, "Supplement Facts," must be set in a type size larger than all other print size in the nutrition label and must be set full width of the nutrition label, as required by 21 CFR 101.36(e)(1). However, the title, "Supplement Facts," on your Runovia product is not set in a type size larger than all other print in the nutrition label, and is not set full width of the nutrition label.
• The subheading "Servings Per Container" must be placed under the subheading "Serving Size" and aligned on the left side of the nutrition label, as required by 21 CFR 101.36(b)(1)(ii). However, the "Servings Per Container" subheading on your Runovia product is not placed under the "Serving Size" subheading, and is not aligned on the left side of the nutrition label.
The product label for your Runovia product lists "Other ingredients" inside the Supplement Facts box. Under 21 CFR 10l.4(g), the ingredient list on dietary supplement products must be located outside and immediately below the Supplement Facts box or if there is insufficient space below the box, immediately contiguous and to the right of the box. Since the excipients, fillers, artificial colors or flavors, and binders listed in the "Other ingredients" list on your Runovia product are not source ingredients or dietary ingredients, they must be listed in an ingredient list outside of the Supplement Facts box.
The violations mentioned above are not intended to be an all-inclusive list of violations. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to assure that your firm complies with all requirements of the Act and its implementing regulations. We advise you to review your websites, product labels, and other labeling and promotional materials for your products to ensure that the claims you make for your products do not cause them to violate the Act.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in enforcement action without further notice, including seizure and injunction. Other federal agencies may take this Warning Letter into account when considering the award of contracts.
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 the violations noted above. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete a corrective action within fifteen (15) working days, state the reason for the delay and the time within which you will complete the correction. If you no longer manufacture or market the aforementioned products, your response should so indicate, including the reasons that, and the date on which, you ceased production.
Please direct your response to the U.S. Food and Drug Administration, 6751 Steger Dr., Cincinnati, Ohio 45237-3097, Attention: K.aren Gale Sego, Compliance Officer.
Sincerely,
/S/
Teresa C. Thompson
Cincinnati District Director
cc: Dr. William Thorn
University of Kentucky
Division of Regulatory Service
103 Regulatory Service Building
Lexington, KY 40546-0275
and
Mark M. Reed, Manager
Kentucky Food Safety Branch, HS1CF
Health Services Building
275 East Main Street
Frankfort, KY 40621
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