Inspections, Compliance, Enforcement, and Criminal Investigations
RHG & Company, Inc., dba Vital Nutrients 18-Nov-08
Department of Health and Human Services
Public Health Service
New England District
VIA FEDERAL EXPRESS
November 18, 2008
Mr. Enrico Liva, President
RHG & Company, Inc., dba Vital Nutrients
45 Kenneth Dooley Drive
Middletown, CT 06457
Dear Mr. Liva:
Food and Drug Administration (FDA) Investigators conducted an inspection of your manufacturing facility located at 45 Kenneth Dooley Drive, Middletown, CT, on April 23 - 24, 2008, and again on June 20, and 25 - 26, 2008. Our inspections revealed that your firm manufactures and distributes products under the Vital Nutrients label and markets them as dietary supplements. This letter concerns your firm's marketing of DMSA (meso-2, 3-dimercaptosuccinic acid) 100mg and 250mg capsules, as well as other products, on your website, www.vitalnutrients.net. According to the information on your website these products are intended to cure, mitigate, treat, or prevent diseases, or to affect the structure or function of the body. Examples of statements on your website that document these intended uses include, but are not limited to, the following:
• "*DMSA (meso-2, 3-dimercaptosuccinic acid) supports the natural mobilization of heavy metals, primarily from soft tissue, especially the blood, brain, kidney, and liver. DMSA is recommended as a single oral chelating agent, supporting normal detoxification of a number of heavy metals."
• "DMSA is recommended as a single oral agent or in combination with other chelating agents for the detoxification of a number of heavy metals, including mercury, lead, cadmium, and arsenic."
• "DMSA reverses some of the lead-induced immunotoxicity."
• "DMSA increases the excretion of zinc and copper."
Your website also included a "DMSA (meso-2,3-dimercaptosuccinic acid) monograph prepared by Herb Joiner-Bay, N.D. and updated by Enrico Liva, RPH, ND," which cites a number of scientific references regarding the use of DMSA as a chelating agent. Furthermore, your product catalog provides a scientific reference "Safety and efficacy of meso-2, 3-dimercaptosuccinic acid (DMSA) in children with elevated blood lead concentrations. J Toxicol Clin Toxicol. 2000;38(4):365-75".
DMSA is a drug, as defined in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act); 21 U.S.C. § 321(g)(l), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Further, Vital Nutrients' DMSA product is a new drug as defined by section 201(p) of the Act, 21 U.S.C. § 321(p), because it is not generally recognized as safe and effective for its labeled uses. Under sections 301(d) and 505(a) of the Act, 21 U.S.C. § 331(d) and 355(a), a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. There is no approved new drug application (NDA) for Vital Nutrients' DMSA product under either section 505(b) or (j) of the Act, 21 U.S.C. § 355(b) or (j). Thus, your sale of DMSA without an approved application violates these provisions of the Act.
DMSA is labeled and marketed on your website as a dietary supplement. However, section 201(ff)(3)(B) of the Act, 21 U.S.C. § 321(ff)(3)(B), specifically excludes from the dietary supplement definition articles that are approved as new drugs under section 505 of the Act (21 U.S.C. § 355), unless the article in question was marketed as a dietary supplement or food before its approval as a drug. FDA approved new drug applications for products containing meso-2,3 dimercaptosuccinic acid on January 30, 1991 (marketed under the name "CHEMET," for the treatment of lead poisoning in pediatric patients) and on May 18, 1982 (marketed under the name "DMSA Kit for the Preparation of Technetium TC-99M Succimer for Injection," for use as an aid in the scintigraphic evaluation of renal parenchymal disorders). To the best of our knowledge, DMSA was not marketed as a dietary supplement or a food before those dates; therefore, regardless of its intended uses, your DMSA product is excluded from the dietary supplement definition.
Furthermore, because this product is offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written so that a layman can use it safely for it its intended uses. Thus, DMSA's labeling fails to bear adequate directions for its intended uses, causing it to be misbranded under section 502(f)(1) of the Act, 21 U.S.C. § 352(f)(1).
While reviewing your website, we noticed that you were promoting other products for disease treatment and/or prevention. The unlawful disease treatment and prevention claims on your website were too numerous to list in this letter. Two examples of violative products, however, are your Co-enzyme Q10 and Glucosamine products. Statements on your website that document that these products are intended to be used to prevent, treat, or cure disease conditions include, but are not limited to, the following:
• "Congestive Heart Failure"
• "Angina pectoris"
• "Breast Cancer"
• "Muscular dystrophy"
• "Studies indicate usefulness in treatment of cardiovascular disorders, breast cancer, and muscular dystrophy."
• "Rheumatoid arthritis with structural complications"
• "Decreases pain, reduces tenderness, improves mobility and function in osteoarthritis."
• "Should be considered basic therapy for the management of primary or secondary degenerative osteoarthrosis disorders."
Co-enzyme Q10 and Glucosamine are drugs, as defined by section 201(g)(1) of the Act, 21 U.S.C. § 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Moreover, these products are new drugs, as defined by section 201(p) of the Act, 21 U.S.C. § 321(p), because they are not generally recognized as safe and effective for the labeled uses. Under Sections 301(d) and 505(a) of the Act, 21 U.S.C. § 331(d) and 355(a), a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. There are no approved new drug applications for Vital Nutrients' Co-enzyme Q10 or Glucosamine products as required by Section 505(b) or (j) of the Act, 21 U.S.C. § 355(b) or (j). Your sale of Co-enzyme Q10 and Glucosamine without approved applications violates these provisions of the Act.
Additionally, because these products are offered for conditions that are not amendable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written so that a layman can use these products safely for the intended uses. Thus, the Co-enzyme Q10 and Glucosamine labeling fails to bear adequate directions for their intended uses, causing them to be misbranded under section 502(f)(1) of the Act, 21 U.S.C. § 342(a)(1).
The issues and violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. 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 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, including, without limitation, seizure and injunction. Other federal agencies may take this Warning Letter into account when considering the award of contracts.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. 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 corrective action within fifteen 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. Additionally, if another firm manufactures these products, identified above, your reply should include the name and address of the manufacturer. If the firm from which you receive these products is not the manufacturer, please include the name of your supplier in addition to the manufacturer.
Address your reply to the U.S. Food and Drug Administration, One Montvale Avenue, Stoneham, MA 02180, Attention: Amber G. Wardwell, Compliance Officer. You may reach Ms. Wardwell at (718) 596-7823.
Anne P. Reid
Acting New England District Director