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FDA NEWS RELEASE
For Immediate Release: June 7, 2011
Media Inquiries: Siobhan DeLancey, 301-796-4668, email@example.com
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FDA: DDS probiotic products seized
Minnesota company claims products prevent or treat disease
U.S. Marshals, at the request of the U.S. Food and Drug Administration, today seized probiotic products from UAS Laboratories, Inc., of Eden Prairie, Minn. because the company markets the products as drugs.
The seized products include DDS Acidophilus, DDS Plus, Probioplus DDS, DDS Junior, and Cran-Gyn DDS, in capsule, powder, and tablet forms.
UAS Laboratories said the products could treat or prevent colds, flu, respiratory infections, urinary tract infections, yeast infections, ulcers, and high cholesterol. The company markets the products in the United States and internationally.
The FDA has warned UAS Laboratories that its products were in violation of federal law. During a March 2011 inspection, the agency discovered that the company continued to make disease claims for the products, despite previous warnings from the FDA.
The Federal Food, Drug, and Cosmetic Act restricts the use of disease claims to approved, or otherwise legally marketed, drugs. The seized products are misbranded under the Act because their labeling does not have adequate directions for use.
To make a claim that a product prevents, treats, cures, or mitigates disease, companies generally must submit a New Drug Application and demonstrate to the FDA that the product is safe and effective for the particular claim. Companies may also market an over-the-counter drug under a monograph.
UAS Laboratories’ products did not conform to any existing monograph, nor did the company file or receive approval of a New Drug Application, and the products are not generally recognized as safe and effective for their recommended uses, according to the complaint filed in U.S. District Court for the District of Minnesota.
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.