Many entrepreneurs want to know whether their invention is a medical device, a drug, a cosmetic, a biologic, or otherwise FDA-regulated.
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.
Grapefruit juice and fresh grapefruit can interfere with the action of some prescription drugs, FDA warns consumers.
Dietary supplement regulation requires companies to seek careful legal guidance before bringing products to market.
As with HCG and other weight loss products in the U.S., weight loss products become the focus of regulation in the Gulf region.
Does your dietary supplement make illegal disease claims or authorized structure/function claims? How do you know?
Manufacturers of new dietary supplements, cosmetics, and nutraceuticals can find legal advice about labeling and FDA-compliant claims by following these guidelines.
Medical use of bioidentical hormones raises legal concerns that can be addressed by solid attorney advice and a carefully crafted informed consent.
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.
Serious legal issues can arise when physicians and CAM practitioners sell dietary supplements.