The Food and Drug Administration (FDA) is getting closer to requiring manufacturers and distributors of dietary supplements to list their products on a public FDA electronic database. On Tuesday, June 14, 2022, the US Senate Committee on Health, Education, Labor, and...
Dietary Supplements
FDA Proposes Collection of Information on Structure/Function Claim Notification Procedures
Structure/function claims commonly appear on dietary supplement labeling, both as a marketing tool and as a means of conveying the benefits of the supplement. Structure/function claims are claims that describe the role of a nutrient or dietary ingredient intended to...
Kratom-Navigating the Murky Regulatory Waters
On March 29, 2021, the Food and Drug Administration (FDA) updated and republished Import Alert 54-15, which allows for the detention without physical examination of dietary supplements containing Mitragyna Speciosa, otherwise known as Kratom. Kratom is a botanical...
Warning Signs You May Get Added to an Import Alert
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Trump to Pharma CEOs — 75-80% less FDA regulations…
Recent headline: Trump to Pharma CEOs: 75% to 80% of FDA Regulations Will be Eliminated Our take... Yeah...not so fast. I expect the Trump-team follow up to be, "we meant 75-80% of the really bad regulations will disappear -- and most likely only in...
Just Because You Can Make “Dietary Supplements” at Home Doesn’t Mean It’s Legal
Anyone manufacturing a product has a dream of building a brand. Like many other regulated industries, long-term success in the dietary supplement industry is dependent on regulatory compliance. A recent Consumer Reports article stated that anyone with a credit card...
FDA Registration Renewal – Get Ahead of the Curve
Between October 1 and December 31 this year, all FDA-registered facilities must renew their registrations. Our team has handled registration renewal for hundreds of facilities. Here are some of our best tips for ensuring the renewal season goes smoothly. Medical...
Dietary Supplement Importer Challenges an Unfair FDA Decision – And Wins
Recently, an importer sought help from our firm because FDA refused its shipment of an herbal supplement after FDA tested the product and alleged that the amount of a certain nutrient in the product was significantly lower than the amount declared on its Supplement...
FDA publishes Hazard Analysis and Risk-Based Preventive Controls (HARPC)
Yesterday, September 10, 2015, FDA released the final rules for Preventive Controls on human and animal foods. This regulation has been a long time in coming, and will drastically change the landscape of food regulations for both domestic and foreign food facilities....
Allegation of Wrong Identity for Dietary Supplements Means Increased FDA Scrutiny for the Whole Industry
The New York attorney general’s office is alleging that the store brand dietary supplements sold by four major retailers are misbranded and adulterated. New York asserts that the products did not contain the declared dietary ingredients, in many cases only contained...