U.S. Food and Drug Administration
CRN Releases Statement on Tianeptine “Supplement” Products
On Jan. 12, The Council for Responsible Nutrition (CRN) issued a warning to consumers against purchasing any “supplements” containing tianeptine. These products contain an illegal opioid-like ingredient that can lead to significant health risks. As the product is widely available in gas stations and convenience stores, it is often nicknamed “gas station heroin.” Tianeptine is ...
James “Jim” Jones to Head FDA Food Division, Industry Associations Respond
The U.S. Food and Drug Administration (FDA) recently announced that it has selected James “Jim” Jones, a 30-year veteran of the Environmental Protection Agency (EPA), to direct its food division as part of a broader reorganization, the agency said. The FDA in January said it would reorganize its food program after being criticized for its slow response ...
Trade Associations Respond to Congressional Request for Information on CBD
The Council for Responsible Nutrition (CRN) and the Natural Products Association (NPA) have submitted responses to a Congressional Request for Information (RFI) seeking insight from industry stakeholders on CBD in order to develop “a regulatory pathway for non-intoxicating hemp-derived cannabinoid products that prioritizes consumer safety and provides certainty to the U.S. markets.” According to CRN, ...
NPA Files Citizen Petition Regarding Labeling of Fungus-Derived Products
In a Citizen Petition submitted to the U.S. Food and Drug Administration (FDA) on August 9, the Natural Products Association (NPA) requested that FDA: Amend 21 C.F.R. § 101 to incorporate labeling aspects based on the American Herbal Products Association’s (AHPA) labeling guidance for mushrooms; and/or Commit to exercising enforcement discretion until the Agency provides ...
FDA Releases Draft Guidance on Registration of Cosmetic Product Facilities and Listings
The U.S. Food and Drug Administration (FDA) has released a draft guidance detailing its plans for the registration of cosmetic product facilities and listing of cosmetic products, two new regulatory requirements applicable to many cosmetic products and their manufacturers under the Modernization of Cosmetics Regulation Act (MoCRA). There are no fees associated with product listing or ...
Kratom Association Releases Consumer Advisory on FDA’s Failure to Regulate Kratom Products
On July 31, the American Kratom Association (AKA) issued a Consumer Advisory on the U.S. Food and Drug Administration’s (FDA) failure to properly regulate kratom products. “The American Kratom Association urges the FDA to immediately publish product manufacturing standards for kratom products that are sold to consumers and encourages the removal of kratom products that ...
NPA Issues Statement in Response to FDA’s Refusal to Hold Public Hearing Regarding NMN
On July 20, the U.S. Food and Drug Administration (FDA) rejected a request by Rep. Jeff Duncan (R-SC), a member of the House Energy and Commerce Committee, to hold a public hearing on the agency’s position on nicotinamide mononucleotide (NMN). FDA stated that a public comment period would be sufficient. In response, the Natural Products ...
AHPA Announces Release of Herbs of Commerce, Third Edition
The American Herbal Products Association (AHPA) has announced the release of the third edition of Herbs of Commerce. The publication provides guidance on the consistent naming of botanical ingredients on product labels, especially those marketed in the U.S. as dietary supplements, according to the association. It is now available for purchase on Amazon. AHPA published ...
Nammex Files Citizen Petition With FDA Over Mushroom Product Labeling
North American Reishi Ltd (Nammex), a Canada-based organic mushroom extract ingredient supplier, filed a citizen petition with the U.S. Food and Drug Administration (FDA). The petition, according to the company, requests that FDA addresses the mislabeling of dietary supplements and functional foods as “mushroom” or containing “mushrooms” when they do not, or fail to disclose ...
CRN Submits Citizen Petition Requesting FDA to Re-interpret Drug Preclusion Clause
The Council for Responsible Nutrition (CRN) has submitted a Citizen Petition to the FDA requesting that the agency to reconsider its interpretation of the Drug Preclusion Clause. According to the Washington, DC-based trade association, the Clause has been, and will likely continue to be, misapplied to dietary supplement ingredients that FDA has previously acknowledged as ...
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