NDI
NPA Proposes Streamlined Data Sharing at FDA
The Natural Products Association (NPA) outlined a streamlined process to facilitate data sharing within the agency in comments to the U.S. Food and Drug Administration (FDA). Specifically, NPA suggested sharing data from the Office of Dietary Supplement Programs on structure/function claim notifications, new dietary ingredient (NDI) notifications, current good manufacturing practice (cGMP) inspections and certificate ...
Senate Confirms Hahn as FDA Commissioner
In a 72-18 Senate vote, Stephen Hahn, MD, FASTRO was confirmed as the new head of the U.S. Food and Drug Administration (FDA), taking charge at a regulatory agency that oversees products ranging from complex cancer drugs, to food, cosmetics, tobacco and CBD. “We look forward to working with Dr. Hahn and his staff to ...
AHPA to Host Inaugural Hemp-CBD Dietary Supplement Congress
The American Herbal Products Association (AHPA) is presenting a two-day Hemp-CBD Supplement Congress in Denver, CO this August to provide critical input for companies navigating the rapidly evolving legal, regulatory and financial landscapes to manufacture and market dietary supplement products with hemp or hemp-derived ingredients including cannabidiol (CBD). The event features presentations from federal officials, ...
Alkemist Labs and REJIMUS Collaborate for GMP Compliance Solutions
Alkemist Labs (Garden Grove, CA) and REJIMUS (Santa Ana, CA) have announced a collaboration to offer comprehensive GMP (good manufacturing practice) compliance solutions to clients, eliminating gaps where many companies are failing GMP audits, NDI (New Dietary Ingredient) applications, and other regulatory-related responsibilities. “FDA (U.S. Food and Drug Administration) has said time and time again ...
FDA’s Request for Supplement Registration Doesn’t Unburden Industry, Says NPA
The Natural Products Association (NPA) recently asked Congress to reject the U.S. Food and Drug Administration’s (FDA) budget request for a product registration system for nutritional supplements, as it’s unclear of what value is added to the agency’s mission of promoting and protecting public health. “The administration has been clear that they want to unburden ...
AHPA NDI Database Shows Increase of Recent Notifications Filed Successfully
Eight of the 21 new dietary ingredient (NDI) notifications released by the U.S. Food and Drug Administration (FDA) between January 1, 2018 and May 31, 2018 were filed by the agency without substantive comment. The vast majority of these (17) complied with all submission regulations (21 CFR 190.6). The recently received data have been analyzed and ...
New Website Gives NPA Members Access to Exclusive Benefits
A new website launched by the Natural Products Association (NPA) will offer new features and resources exclusively for members, including a warning letter database, searchable disease claims database, Pre-DSHEA (Dietary Supplement Health and Education Act of 1994) ODI (old dietary ingredient) list, Red-Flagged Ingredients database, and educational and regulatory resources. In addition, NPA is working on a searchable ...
NDI Database Shows 15 of 59 Recent Notifications Acknowledged Without Objection
Fifteen (or roughly 25 percent) of the 59 New Dietary Ingredient (NDI) notifications submitted to the U.S. Food and Drug Administration (FDA) between November 2015 and October 2016 were acknowledged without objection, according to the latest data uploaded to AHPA’s (American Herbal Product Association) NDI Database. Several of these 15 notifications were for ingredients that a company ...
NPA: New Congress Brings Opportunity for Natural Products Industry
As part of the effort to capitalize on the opportunities the incoming Congress presents for the natural products industry and the millions of American consumers using its products, The Natural Products Association (NPA) announced that it will host the 20th Annual Natural Products Day on Wednesday, March 22, 2017 in Washington, D.C. “A new Congress ...
Associations Submit Comments on Revised NDI Draft Guidance
Some of the natural product industries’ leading associations, including the American Herbal Products Association (AHPA), Council for Responsible Nutrition (CRN), American Botanical Council (ABC) and Natural Products Association (NPA), recently submitted comments to U.S. Food and Drug Administration (FDA) in response to the agency’s revised New Dietary Ingredient (NDI) Draft Guidance. FDA issued on August ...
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