The nutritional supplement industry is growing fast in the United States. The demand for products that promote health and wellness is driven by a rapidly aging population, concern for chronic diseases, as well as an increasingly health-conscious younger generation. In turn, this creates stiff competition for business owners who choose to venture into this industry.…
Four dietary supplement trade groups on Tuesday urged Congress to pass legislation clarifying hemp-derived CBD is a lawful dietary ingredient if the supplement meets established product safety and quality criteria. Lawmakers also were asked to devote sufficient resources to shield consumers from unsafe CBD products. While FDA has been examining the potential for a rulemaking…
As FDA continues to contemplate potential regulatory pathways for hemp-derived CBD, an increasing number of states are moving forward with their own laws and policies aimed at regulating this popular product category, especially in the dietary supplement and food space. Several states are imposing robust testing, labeling and registration requirements for these products—with more likely…
Amarin Pharma Inc. wants the nation’s highest court to hear a long-running dispute with several dietary supplement companies that the U.S. International Trade Commission (ITC) declined to investigate in 2017. Amarin, the maker of the pharmaceutical drug Vascepa, filed a July 30 petition for a writ of certiorari with the U.S. Supreme Court after an appeals court…
U.S. Sen. Ron Wyden on Tuesday urged top federal health officials to announce a “formal enforcement discretion policy” by Aug. 1 regarding CBD as a food additive or dietary ingredient in supplements. Without such a policy, “hemp producers and their customers will continue to be left in a regulatory gray zone,” Wyden, a Democrat from…
FDA has many “unanswered questions” when it comes to the safety of cannabidiol (CBD), a cannabis-derived compound, the agency’s top official said last week. FDA Acting Commissioner Norman “Ned” Sharpless, M.D., cited “real risks” and “critical questions” that remain regarding the safety of CBD and tetrahydrocannabinol (THC) in FDA-regulated products, including food and dietary supplements.…
“Time is of the essence.” The statement, made by Andrew Kline of the National Cannabis Industry Association (NCIA), encapsulates the views of many people who attended a recent public hearing hosted by FDA on cannabidiol (CBD) products. During the May 31 hearing in Silver Spring, Maryland, several speakers urged FDA to provide clarity to a…
Only a small fraction of the ingredient notifications required under the Dietary Supplement Health and Education Act of 1994 (DSHEA) have been submitted to FDA since the 1990s, an agency official concluded during a May 16 public meeting. Distributors and manufacturers must notify FDA, providing the agency evidence of safety 75 days before introducing a new…
FDA announced today a new tool designed to quickly alert consumers of ingredients unlawfully marketed as supplements. Dubbed the Dietary Supplement Ingredient Advisory List, the tool is intended to provide rapid notification to consumers of unlawful ingredients in order to better protect them from potentially dangerous ingredients. Included in the list are ingredients FDA deems not…
Despite the recent departure of Scott Gottlieb from FDA, the dietary supplement initiatives he set in motion are expected to continue under his successor. But it remains to be seen whether any substantive changes to supplement regulations or policies will be adopted under the current interim FDA commissioner. Gottlieb, a physician who served as commissioner…