Many entrepreneurs want to know whether their invention is a medical device, a drug, a cosmetic, a biologic, or otherwise FDA-regulated.
Dietary Supplements
Legal action pushes FDA on its response to qualified health claims
A federal judge recently held that the disclaimer required by the FDA for a qualified health claim about green tea and the risk of cancer is so strongly worded that it “effectively negates” the manufacturer’s claim.…
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FDA warns consumers about grapefruit juice
Grapefruit juice and fresh grapefruit can interfere with the action of some prescription drugs, FDA warns consumers.…
Dietary supplements regulations make IRS rules read like Hemingway
Dietary supplement regulation requires companies to seek careful legal guidance before bringing products to market.…
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Weight loss products raise legal issues
As with HCG and other weight loss products in the U.S., weight loss products become the focus of regulation in the Gulf region.…
R U Making Unauthorized Disease Claims with Your Dietary Supplements
Does your dietary supplement make illegal disease claims or authorized structure/function claims? How do you know?…
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Legal Advice For New Dietary Supplement, Nutritional Product or Cosmetic
Manufacturers of new dietary supplements, cosmetics, and nutraceuticals can find legal advice about labeling and FDA-compliant claims by following these guidelines.…
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Physician use of bioidential hormones raises legal concerns
Medical use of bioidentical hormones raises legal concerns that can be addressed by solid attorney advice and a carefully crafted informed consent.…
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Is it legal for an integrative care center, medical spa, or clinical practitioner to make a profit by selling dietary supplements?
The question of selling dietary supplements in the clinical care setting arises with many clients in the holistic health care field who care about legal and regulatory issues.…
When Integrative Medicine Physicians Sell Dietary Supplements: Legal Issues
Serious legal issues can arise when physicians and CAM practitioners sell dietary supplements.…
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