This article has been updated with comments from the industry. Washington, D.C.—The Food and Drug Administration (FDA) has issued Guidance for Industry: Policy Regarding N-acetyl-L-cysteine. The guidance advises dietary supplement manufacturers, distributors, and other stakeholders of FDA's intent to exercise enforcement discretion with respect to the sale and distribution of certain...
Washington, D.C.—As WholeFoods Magazine has reported, a new report published in the Journal of the American Medical Association (JAMA; vol. 328, no. 4) suggests that FDA warning letters are falling short when it comes to deterring bad actors from selling dietary supplements adulterated with novel and unapproved stimulants linked to serious...
Washington, D.C.—The 7th annual Dietary Supplements Regulatory Summit, held in Washington D.C. and virtually on July 21, 2022, hosted briefings from the Food and Drug Administration (FDA), toxicologists in the field, legal professionals, and more. Speakers dissected trends in the nutritional supplements market and educated on pressing issues for industry...
Silver Spring, MD—The American Herbal Products Association (AHPA) has submitted comments in response to FDA’s draft guidance on new dietary ingredient (NDI) filings and enforcement discretion. (Background: CRN Reacts to FDA’s NDI Enforcement Discretion Draft Guidance.) While expressing support for FDA’s proposal to offer a period of enforcement discretion for the...
Washington, D.C.—FDA warning letters are falling short when it comes to deterring bad actors from selling dietary supplements adulterated with novel and unapproved stimulants linked to serious health risks. That's according to a new report published in the Journal of the American Medical Association (JAMA; vol. 328, no. 4). Pieter...
Washington, D.C.—The Council for Responsible Nutrition (CRN) has submitted comments in response to FDA’s draft guidance on new dietary ingredient (NDI) filings and enforcement discretion. (Background: CRN Reacts to FDA’s NDI Enforcement Discretion Draft Guidance.) As CRN noted, the NDI filing and enforcement discretion paradox has been a hot-button issue affecting the...
Silver Spring, MD—On June 30, 2022, the Food and Drug Administration (FDA) issued warning letters, jointly with the Federal Trade Commission (FTC), to four companies selling kratom products. FDA stated that it has not approved kratom for the treatment or cure of opioid use disorder and withdrawal symptoms. FDA also...
Washington, D.C.—Earlier this year, the Senate Health, Education, Labor, and Pensions (HELP) Committee released a discussion draft of legislation to reauthorize FDA user fees for drugs, biologics, and medical devices—and the legislation includes the Durbin-Braun premarket approval concept. As WholeFoods Magazine reported, the Natural Products Association (NPA) has been cautioning...
Washington, D.C.—As WholeFoods Magazine previously reported, the Centers for Disease Control (CDC) recently released data regarding the use of melatonin in children. The study authors reported that: During 2012–2021, the annual number of pediatric ingestions of melatonin increased 530% (a total of 260,435 ingestions reported) Pediatric hospitalizations and more serious outcomes...
Washington, D.C.—As WholeFoods Magazine previously reported, the Centers for Disease Control (CDC) has released data regarding the use of melatonin in children. The finding: During 2012–2021, the annual number of pediatric ingestions of melatonin increased 530% (a total of 260,435 ingestions reported). CDC noted that "pediatric hospitalizations and more serious...
