fda
FDA Considering Vinpocetine Ineligible as a Dietary Ingredient
The U.S. Food and Drug Administration (FDA) recently released an unprecedented Federal Register (FR) notice (Docket No: FDA-2016-N-2523) with major implications for acknowledged new dietary ingredient (NDI) notifications. FDA appears to be attempting to shift the burden of demonstrating reasonable expectation of safety for vinpocetine on the industry by using the hook that it can’t ...
FDA Releases Revised Draft of NDI Guidance; AHPA Convenes Working Group for Comments
The Food and Drug Administration (FDA) today released revised draft guidance for new dietary ingredients (NDIs) to be published in the Federal Register on Friday, Aug. 12. The revised draft replaces FDA’s 2011 draft. The guidance, “Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues,” is subject to a 60-day comment period. ...
NPA Launches Warning Letter Database for Member Companies
The Natural Products Association (NPA) has announced the launch of its highly anticipated warning letter database. This database will be a free online tool for NPA members to view violations against the dietary supplement good manufacturing practices (GMPs), which are deemed as ‘technical adulterations’ by the FDA (U.S. Food and Drug Administration), dietary supplement labeling ...
Homeopathic Association Works with FDA to Educate Manufacturers
The American Association of Homeopathic Pharmacists’ (AAHP) latest educational webinar illustrates the homeopathic industry fostering a relationship with the U.S. Food and Drug Administration (FDA) to ensure the highest quality of safe medicines to retailers, consumers and health practitioners across the U.S. Per the request of AAHP, the agency provided staff to present updates on its Compliance Policy for homeopathic products directly to ...
OnlineLabels.com Launches Free Tools to Make Product Label Updates Easier
OnlineLabels.com is updating and adding brand new tools and content for their users in response to the U.S. Food and Drug Administration (FDA) announcing new format changes to nutrition facts found on food labels. The label retailer recently re-launched their free nutrition label generator to include the new required format in order to ease the ...
Industry Urges FDA to Define “Natural”
The American Herbal Products Association (AHPA) submitted comments to the U.S. Food and Drug Administration (FDA) encouraging the agency to establish, through rulemaking, a regulatory definition for the term “natural” (and possibly other terms, such as “100 percent natural” and “made with natural [named ingredient(s)]”) for the labeling of human food products, and other products ...
FDA Recognizes Canada as Having a Comparable Food Safety System to the U.S.
The U.S. Food and Drug Administration (FDA) signed an arrangement with the Canadian Food Inspection Agency (CFIA) and the Department of Health Canada (Health Canada) recognizing each other’s food safety systems as comparable to each other. The arrangement was signed at a meeting of the FDA-CFIA Health Canada Joint Committee on Food Safety. This is the second ...
FDA Approves Folic Acid to be Added to Masa Flour
The U.S. Food and Drug Administration (FDA) has decided to allow manufacturers to fortify their corn masa foods with folic acid. “Folic acid is a synthetic form of folate, a B vitamin that helps prevent severe defects of the brain and spinal cord when consumed by women before and early [on] in pregnancy,” an NPR ...
AHPA Advocacy Spurs Correction of FDA’s Dietary Supplement Labeling Guide
The U.S. Food and Drug Administration (FDA) has corrected its Dietary Supplement Labeling Guide after the American Herbal Products Association (AHPA) notified the agency of inaccurate information posted online. AHPA notified FDA in September 2015 that its guidance for industry titled “A Dietary Supplement Labeling Guide,” included one detail that contradicted current law and FDA regulations. ...
NPA Sends Letter to New FDA Commissioner
The Natural Products Association (NPA) sent a letter to Dr. Robert Califf regarding his recent confirmation to become the new commissioner of the U.S. Food and Drug Administration (FDA). In the letter, NPA congratulated Califf on his confirmation by the U.S. Senate and outlined its priorities for the new commissioner. NPA also requested a meeting ...
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