March 28, 2005
FDA Warning Letters
WASHINGTONTheFood and Drug Administration (FDA) issued several warning letters to companiesselling dietary supplements.
On Jan. 4, FDA issued a warning letter to IONETICSfollowing a review of labeling for its productAngioprim. FDA took issue with label claims and Web site claims claiming theproduct could clean blocked arteries without surgery, needles or hazardousdrugs and could reverse cardiovascular disease and symptoms of arthritis,osteoporosis, Alzheimers disease and diabetes. FDA noted the claims positionthe product as an unapproved new drug, which may not be marketed in the UnitedStates.
On Jan. 20, FDA issued an amended warning letter to BasicResearch LLC in Salt Lake City, extending its purviewto include two additional productsMamralin-ARa and TestroGel. The agency determined all five products are marketed withclaims that cause the products to be drugs rather than dietary supplements; assuch, they are unapproved new drugs.
FDA sent a warning letter on Feb. 4 to MerazonHealth Products Inc. regarding its product ImmuneGuard. The agency reviewed Merazons Web site and found Internet label claimspositioning the product as a preventive or treatment for influenza, positioningthe product as a drug. As such, the product is an unapproved new drug andmisbranded as a drug because it does not bear adequate directions for use.
ABCO Laboratories receivedan FDA warning letter dated Feb. 23 related to Web site promotional statementsfor its spirulina powder. Among the disputed information was a statement thatspirulina is a rich source of the carotenoids and phycocyamin which areassociated with cancer preventive agents in the diet. FDA noted in the letterthat some Internet distributors may not be familiar with the federal regulationson structure/function claims for dietary supplements, and suggested furtherreview of the regs.
FDA issued a March 1 warning letter to USAChemicals Inc. and Perry M. Belcher Companies relatedto a review of several Web sites for products including Welatonin, Digestrin,Veinocal, Chitorex, Goutin and Canthorex. The agency alleged the products arepromoted with therapeutic claims that position the products as drugs. Among theclaims include Welatonins ability to defeat depression cold turkey,Digestrins ability to eliminate IBS [irritable bowel syndrome] forever inless than 72 hours, and Goutins ability to eliminate severe gout pain.Also, FDA singled out a claim for Chitorexs ability to absorb 2,000 times itsweight in fat and convert it to a non-digestible gel to ensure satiety as notsupported by reliable scientific evidence, causing the product to be misbranded.Finally, Cathorex was also singled out as an adulterated cosmetic because itscanthaxanthin ingredient is a color additive that is unapproved for a cosmeticuse.
Universal Nutrition Services receiveda March 7 FDA warning letter following the September visit of an FDA inspectorto the companys manufacturing facility. FDA tested several different productsand found the products were adulterated, because they were missing severalingredients listed on the label, and were also misbranded. The agency alsoquestioned the positioning of its Uni-Syn MRP2 as a meal replacement and dietarysupplement, as well as the use of a low in sugar claim, which it foundfalse compared to similar products.
FDA issued a warning letter March 17 to AlternativeHealth & Herbs Remedies after a September on-siteinspection of the companys manufacturing facility. FDA found significantdeviations from current GMP (good manufacturing practice) regulations forpharmaceuticals related to production of products for eye health or as eyerinses. Among the reported violations were failure to follow written proceduresto ensure sterility of products, failure to sterilize drug products andcontainers, failure to conduct appropriate lab testing on its products, andfailure to hold products until cleared by lab testing. Further FDA concerns werenoted on products including Parsley, Eyebright and Squaw Vine, which weremarketed for eye disorders despite the active ingredients lack of GRAS(generally recognized as safe) approval for the labeled indications.
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