Inspections, Compliance, Enforcement, and Criminal Investigations
Reliv International, Inc. 27-Jul-01
DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration
Kansas City District
P.O. Box 15905
Lenexa, Kansas 66285-5905
Telephone: (913) 752-2100
July 27, 2001
RETURN RECEIPT REQUESTED
Ref. KAN 2001-029Carl Hastings, Ph.D.
Executive Vice President
Reliv International, Inc.
136 Chesterfield Industrial Blvd.
P.O. Box 405
Chesterfield, MO 63005-0405
Dear Dr. Hastings:
An inspection of your firm located at the above address on March 19-20, 2001 revealed that you manufacture various dietary supplements. Our review of your products? labels reveals that certain products are misbranded and in violation of Section 403 of the Federal Food, Drug, and Cosmetic Act (the Act), and Title 21, Code of Federal Regulations (21 CFR), Part 101- Food Labeling, as follows:
1, The products, "Classic", "SoySentials", "FibRestore", "Soy Sense" and "Arthaffect", are misbranded within the meaning of Section 403(q)(5)(F) of the Act in that these labels fail to bear the correct nutrition labeling format ("Supplement Facts" panel), which is required under 21 CFR 101.36, and are not exempt from this requirement.
2. The products, "Classic", "?SoySentials", "FibRestore", ?gSoy Sense" and "?Arthaffect", are misbranded within the meaning of Sections 403(i)(1) and 403(s)(2)(B) of the Act in that the label fails to identify the products using the term dietary supplement [21 CFR 101.3(g)], or other alternative descriptive term authorized by regulation.
Most of the above violations concern certain new labeling requirements, and are not meant to be an all-inclusive list of deficiencies on your labels. Other Iabel violations can subject the dietary supplements to legal action. It is your responsibility to assure that all of your products are labeled in compliance with all applicable statutes and regulations enforced by the U.S. Food and Drug Administration (FDA).
You should know that these serious violations of the law may result in FDA taking regulatory action without further notice to you. These actions include, but are not limited to, seizure and/or obtaining a court injunction against further marketing of your dietary supplements.
It is necessary for you to take action on these matters now. Please let this office know in writing within fifteen (15) working days from the date you received this letter what steps you are taking to correct the problems. We also ask that you explain how you plan to prevent these violations from happening again. If you need more time, let us know why and when you expect to complete your correction.
Your reply should be sent to Clarence R. Pendleton, Compliance Officer, at the above address.
Kansas City District