Inspections, Compliance, Enforcement, and Criminal Investigations
Ganeden Biotech Inc. 08-Dec-06
Department of Health and Human Services
Public Health Service
Cincinnati District Office
December 8, 2006
VIA FEDERAL EXPRESS
WARNING LETTER CIN-07-31056-07
Andrew R. Lefkowitz
President and Chief Executive Officer
Ganeden Biotech, Inc.
5915 Landerbrook Drive, Suite 304
Mayfield Heights, OH 44124-4034
Dear Mr. Leflcowitz:
An Investigator from the U.S. Food and Drug Administration (FDA) performed an inspection of your facility from August 30, 2006 to August 31, 2006. During the inspection, the investigator collected labels and other labeling from some of your products, including Digestive AdvantageTM Lactose Intolerance Therapy, Digestive AdvantageTM Children's Lactose Intolerance Therapy, Dermal AdvantageTM Psoriasis, Digestive AdvantageTM Constipation Therapy, Arthritis AdvantageTM Arthritis Therapy, Digestive AdvantageTM Crohn's & Colitis Therapy, Digestive AdvantageTM Gas Prevention Therapy, and Digestive AdvantageTM Irritable Bowel Syndrome. FDA has reviewed your labels and labeling for,these products and found serious violations of the Federal Food, Drug, and Cosmetic Act (the Act). You can find the Act and its implementing regulations on FDA's website at http://www.fda.gov
Your products are labeled as "medical foods," and the product names and labeling claims represent the products as intended for use for diseases and other medical conditions. However, your products do not meet the definition of a medical food in 21 USC 360ee(b)(3), which defines a medical food as a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation. The regulations further define a medical food as one that is intended for the dietary management of a patient who has special medically determined nutrient requirements, the dietary management of which cannot be achieved by the modification of the normal diet alone [21 CFR 101.96)(8)(ii)]. Your products are not medical foods because the diseases and conditions described in the product labels do not have distinct nutritional requirements established by medical evaluation and because the products do not have any unique impact on the dietary management of those diseases and conditions beyond that which could be achieved by modification of the normal diet alone.
Your products Digestive AdvantageTM Lactose Intolerance Therapy, Digestive AdvantageTM Children's Lactose Intolerance Therapy, Dermal AdvantageTM Psoriasis, Digestive AdvantageTM Constipation Therapy, Arthritis AdvantageTM Arthritis Therapy, Digestive AdvantageTM Crohn's & Colitis Therapy, Digestive AdvantageTM Gas Prevention Therapy, and Digestive AdvantageTM Irritable Bowel Syndrome are misbranded within the meaning of Section 403(a)(1) of the Act 21 U.S.C. § 343(a)(1)] because the labels are false or misleading in that the products are labeled as medical foods but do not meet the definition of a medical food. In addition, since they are not medical foods and are not subject to the exemption from nutrition labeling afforded to medical foods, your products are also misbranded within the meaning of Section 403(q)(1) of the Act [21 U .S.C. § 343(q)(1)] because the labels do not bear nutrition labeling in the Nutrition Facts format, as required in 21 CFR 101.9.
Furthermore, the names of your products below and claims in their labeling indicate that the products are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease in man. Similar claims and testimonials appear on your website at http://www.ganedenbiotech.com. Examples of disease claims in your product labeling include the following:
• Dermal AdvantageTM Psoriasis "For Daily Dietary Management of Psoriasis," "[H]elps to eliminate the symptoms of psoriasis," and "Helps Relieve: Redness, Cracking, Flaking, and Irritation."
• Digestive AdvantageTM Once Daily Chronic Constipation Therapy. "For Those Who Suffer From Chronic Constipation" and "Helps Relieve Chronic Constipation."
• Arthritis AdvantageTM Once Daily Arthritis Therapy "Clinically Proven to Reduce Pain & Increase Mobility" and "For Daily Dietary Management of Arthritis."
• Digestive Advantage TM Once Daily Crohn's & Colitis Therapy "For Daily Dietary Management of Crohn's & Colitis," "Helps Reduce Episodes of Diarrhea" and "In a recent clinical study patients with Crohn's noted a 40% reduction in episodes of diarrhea. Experience the results for yourself."
• Digestive Advantage TM Once Daily Irritable Bowel Syndrome "Clinically Proven to Manage Abdominal Pain and Bloating" and "For Daily Dietary Management of Irritable Bowel Syndrome."
These claims, including the product names, are evidence that your products are intended for use as drugs within the meaning of Section 201(g)(1)(B) of the Act. Your products are also new drugs under section 201(p) of the Act because there is no evidence that these products are generally recognized as safe and effective for their intended uses. 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)].
The above violations are not meant to be an all-inclusive list of deficiencies in your products and their labeling. It is your responsibility to ensure that products marketed by your firm comply with the Act and its implementing regulations.
The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributor of those products. You should take prompt action to correct these deviations and prevent their futures recurrence. Failure to do so may result in enforcement action without further notice. Federal agencies are advised of the issuance of all Warning Letters about drug products so that they may take this information into account when considering the award of contracts.
Please notify this office, in writing, within fifteen (15) working days of the receipt of this letter, as to the specific steps you have taken to correct the violations noted above and to assure that similar violations do not occur. Include any documentation necessary to show that correction has been achieved. If corrective actions cannot be completed within fifteen working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be directed to Stephen J. Rabe, Compliance Officer at the address listed above. You can contact Mr. Rabe at 513-679-2700 ext. 163 with any questions regarding this letter.
Carol A. Heppe