On December 20, the Federal Trade Commission’s Bureau of Consumer Protection announced the issuance of Health Products Compliance Guidance. The revised Guidance updates the FTC’s 1998 guide, Dietary Supplements: An Advertising Guide For Industry, and is a must read for everyone involved in marketing, labeling, and creating and evaluating substantiation for dietary supplements and
Compounding the Fraud: Questionable Billing by Pharmacies
Rivkin Radler partners Evan Krinick and Michael Sirignano authored an article, “Compounding the Fraud: Questionable Billing by Pharmacies,” in the July 6 issue of the New York Law Journal. The article discussed the U.S. Department of Justice’s continued concern over fraudulent claims for reimbursement to federal healthcare programs for compounded prescription drugs.
COVID-19 and Legal Chaos Dent CBD Market
Rivkin Radler’s Marc Ullman was quoted in the NutraIngredients-USA article, “COVID-19 and legal chaos dent CBD market – but Congress and a stronger economy offer hope.” The article discusses the state of the CBD market amid the COVID-19 pandemic and legal battles.
“The market is a mess and the FDA doesn’t want to
FDA Issues Medical Device Safety Guidance for MRI Facilities
On May 19, the U.S. Food and Drug Administration (FDA) issued final guidance for assessing the safety and compatibility of medical devices within magnetic resonance imaging facilities. The guidance applies to implanted devices, external devices like insulin pumps and pulse oximeters, and any other devices that may be brought into MRI rooms, but not to
Free Drug Program Avoids Sanctions Under AKS
In a recent advisory opinion, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) determined not to impose sanctions under the federal Anti-Kickback Statute (AKS) on a drug manufacturer program that offers a free drug to certain eligible patients. The manufacturer uses personalized medicine technology to make the drug from
Shapiro Quoted on CBD Warning Letters in Vitamin Retailer
A March 26 article in Vitamin Retailer, “FDA Warns Selling of Topical CBD Products Violates FD&C Act,” discussed the two warning letters recently issued by the U.S. Food and Drug Administration (FDA) to two companies for selling topical pain relief products containing CBD. The FDA claims that the sale of the products
FDA Warns that Topical Pain-Relief Products Containing CBD Violate FD&C Act
This week, the U.S. Food and Drug Administration (FDA) issued Warning Letters that effectively declare that the presence of cannabidiol (CBD) as an inactive ingredient in topical over-the-counter (OTC) drug products is a violation of the federal Food, Drug, and Cosmetic Act (FD&C Act).
In a news release issued on March 22, 2021 the FDA