The Organic & Natural Health Association (O&N Health) has always prioritized strategic planning; our focus lies in identifying the key issues that act as standard bearers within our supply chain. By delving deep into these concerns, we uncover underlying threats and forge new pathways to achieve different outcomes.
Silver Spring, MD—The American Herbal Products Association (AHPA) has submitted comments in response to FDA’s draft guidance on new dietary ingredient (NDI) filings and enforcement discretion. (Background: CRN Reacts to FDA’s NDI Enforcement Discretion Draft Guidance.)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Washington, D.C.—The Council for Responsible Nutrition (CRN) has submitted comments in response to FDA’s draft guidance on new dietary ingredient (NDI) filings and enforcement discretion. (Background: CRN Reacts to FDA’s NDI Enforcement Discretion Draft Guidance.)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...
On May 19, the U.S. Food and Drug Administration has released a draft guidance outlining a proposed policy to give companies an opportunity to submit late new dietary ingredient (NDI) notifications. If finalized, the draft guidance will "advise the dietary supplement industry that FDA intends to exercise enforcement discretion, for a limited time...
Two of DSM’s probiotic strains have received New Dietary Ingredient status from FDA, according to a press release. Lactobacillus rhamnosus 19070-2 and Lactobacillus reuteri 12246-CU are already commercially available in Europe, Asia, and the Middle East, and with the no-objection NDI status, are now available in the U.S. “The NDI...
Virtual—Members of the natural products industry expressed frustration with FDA, calling interactions “disheartening.” At the 2022 NYSBA Annual Meeting, a panel discussion focused on intellectual property and FDA’s protection of it, or lack thereof. Mark Ullman, Of Counsel, Rivkin Radler, moderated the meeting, and opened with an anecdote regarding Mitsubishi...
Denver, CO—HempFusion Wellness has announced that its exclusive and proprietary hemp-derived CBD extract has achieved self-affirmed GRAS, which the company expects to drive significant incremental revenue growth at retail, according to a press release. “Self-affirmed GRAS status is a major milestone that only a select few highly responsible CBD companies...
A recent Op-Ed that appeared in Bloomberg Opinion suggested that FDA’s current caution and risk aversion tied to COVID-19 needed to extend immediately into dietary supplements. Not only is this piece misguided, it propagates numerous falsehoods that we, as the supplements industry, have been trying to debunk for decades. If...
Washington, D.C.—The Natural Products Association (NPA) announced that it has submitted comments to the Food and Drug Administration (FDA) regarding “Food Standards; General Principles and Food Standards Modernization.” NPA's message: The Agency needs to do more to stop fraudulent products from entering the U.S. One of NPA's concerns: “economic adulteration"—firms replacing...
Virtual—“COVID is not going to stop our attempt to spread truthful science and information,” said Raqiyyah Pippins, Partner at Arnold & Porter Kaye Scholer LLP, as she opened the session "Examining New Trends in Claims Substantiation: A Study of Innovative Claims, Ever Increasing Use of Influencers to Promote Products, and...
