Washington, D.C.—On April 14, the U.S. Congress passed the Food Allergy Safety, Treatment, Education, and Research (FASTER) Act of 2021; on April 23, President Biden signed it into law. One major impact: Along with the top eight major allergens (milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, and soybean), sesame...
“Big picture: The important thing here is that the supplement industry has grown tremendously over the last 20+ years,” said DSQC Steering Committee Chair Christine Burdick-Bell, in an interview with WholeFoods Magazine. “The industry has literally grown 10-fold since DSHEA was passed.” That growth comes with issues that DSHEA didn't...
Mitigate the Regulatory Risk by Prioritizing Claim Substantiation Three current trends in consumer retail behavior reflect the changes in consumer attitudes caused by coronavirus disease 2019 (“COVID-19”): a focus on better (1) self-care, (2) mental health, and (3) convenience in the delivery of healthcare. These consumer trends have created a...
Silver Spring, MD—FDA has issued warning letters to two companies for selling products labeled as containing cannabidiol (CBD) in ways that violate the FD&C Act. Honest Globe Inc. and Biolyte Laboratories LLC have marketed pain relief products that the FDA is calling unapproved new drugs. Honest Globe was warned in...
Silver Spring, MD—The Food and Drug Administration (FDA) issued a news release announcing that Judge Edward R. Korman, of the U.S. District Court for the Eastern District of New York, entered an order of permanent injunction against Confidence USA Inc., of Long Island, New York, and two of its executives:...
Washington, D.C.—The Council for Responsible Nutrition has submitted comments on FDA’s Proposed Rule for Requirements for Additional Traceability Records for Certain Foods, asking for confirmation that dietary supplements will be exempt. The rule is intended to help industry more rapidly and effectively trace food products that cause illnesses back to...
Silver Spring, MD—FDA has warned 10 companies for illegally selling supplements claiming to treat mental health disorders, according to a press release. The warning letters were issued to Enlifta LLC; Lifted Naturals; Mountain Peak Nutritionals; SANA Group LLC.; Wholesome Wellness; Dr. Garber’s Natural Solutions; ProHealth Inc.; Blossom Nature LLC; FDC...
Washington, D.C.—Effective March 15, 2021, Steve Tave will transition from his role as Director of FDA's Office of Dietary Supplements Programs (ODSP) to a new position as principal advisor in the Office of Regulatory Affairs (ORA). The Council for Responsible Nutrition (CRN) commended Tave on his commitment to public health...
Washington, D.C.—Representatives Kurt Schrader (D-OR) and Morgan Griffith (R-VA) have introduced a bill that would allow hemp and cannabidiol (CBD) to be marketed and sold as supplements. “Reps. Schraeder and Griffith have shown true leadership on this issue, and we anticipate support continuing to build as it progresses through Congress,”...
Following a Biden administration memo to all federal agencies directing them to withdraw pending rules, the Federal Drug Administration (FDA) has withdrawn its "Cannabidiol Enforcement Policy; Draft Guidance for Industry." The Guidance was at the Office of Management and Budget (OMB) awaiting review. The memo explained that the action is...
