Washington, D.C.—The Centers for Disease Control (CDC) has released data regarding the use of melatonin in children. CDC reports that, during 2012–2021, the annual number of pediatric ingestions of melatonin increased 530% (a total of 260,435 ingestions reported). CDC also noted that "pediatric hospitalizations and more serious outcomes also increased,...
On May 19, the U.S. Food and Drug Administration has released a draft guidance outlining a proposed policy to give companies an opportunity to submit late new dietary ingredient (NDI) notifications. If finalized, the draft guidance will "advise the dietary supplement industry that FDA intends to exercise enforcement discretion, for a limited time...
Washington, D.C.—The Senate Health, Education, Labor, and Pensions (HELP) Committee has released a discussion draft of its legislation to reauthorize FDA user fees for drugs, biologics, and medical devices—and the legislation includes the Durbin-Braun premarket approval concept. The Natural Products Association (NPA) is cautioning that this would be damaging to...
Silver Spring, MD—On May 9, 2022, the Food and Drug Administration (FDA) announced that it had issued warning letters to 11 companies for selling adulterated dietary supplements. Listed among those 11 companies was Glanbia Performance Nutrition (Manufacturing) Inc., but in an updated announcement posted by FDA on May 10, 2022, Glanbia...
Update (May 10, 2022, 3:20 pm ET): FDA's original announcement on May 9, 2022, as reported in an earlier version of this article, listed Glanbia Performance Nutrition (Manufacturing) Inc. among the companies that received warning letters. In an updated announcement posted on May 10, 2022, Glanbia was removed from FDA's announcement, and is...
Washington, D.C.—The U.S. Food and Drug Administration (FDA) announced that it has issued warning letters to five companies for selling products labeled as containing delta-8 tetrahydrocannabinol (delta-8 THC) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). FDA said this is the first time warning letters...
Washington, D.C.—The Dietary Supplement Listing Act of 2022 has been introduced by Senators Richard Durbin (D-IL) and Mike Braun (R-IN) with the intent of establishing a requirement for mandatory product listing (MPL) for all dietary supplements marketed in the United States. The aim of the bill, according to the authors:...
Washington, D.C.—The U.S. Food and Drug Administration (FDA) announced in a Constituent Update that it is issuing “Policy Regarding N-acetyl-L-cysteine: Draft Guidance for Industry” to be published on April 22, 2022. FDA said the draft guidance, when finalized, will explain the agency's intent to exercise enforcement discretion with respect to...
Washington, D.C.—In July 2020, the U.S. Food and Drug Administration (FDA) sent warning letters to seven supplement companies selling products containing N-acetyl-L-cysteine (NAC), claiming that NAC was not lawful for sale as an ingredient in a dietary supplement because NAC had already been approved as a drug prior (in 1963)...
Silver Spring, MD—The Food and Drug Administration (FDA) has issued an updated consumer update titled 5 Things to Know about Delta-8 Tetrahydrocannabinol – Delta-8 THC. The agency said the notification is in response to an increase in adverse event reports to FDA and poison control centers, online marketing that appeals...
