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FDA Issues Draft Guidance on NDIN Master Files for Dietary Supplements

by Shari Barbanel | April 4, 2024

On April 3, the U.S. Food and Drug Administration (FDA) announced the availability of a draft guidance for industry titled “New Dietary Ingredient Notification Master Files for Dietary Supplements.” The draft guidance is the FDA’s response to the dietary supplement industry’s requests for specific guidance on recommendations about master files for new dietary ingredient notifications ...

AHPA Recommends FDA Implement Policies to Support Responsible Innovation

by Shari Barbanel | July 18, 2019

The American Herbal Products Association (AHPA) submitted extensive and specific policy recommendations on July 15 to the U.S. Food and Drug Administration (FDA) to support responsible dietary supplement innovation while preserving and strengthening FDA’s ability to efficiently and effectively protect the public from unsafe and unlawful products. AHPA submitted these recommendations to FDA in response to an ...

FDA to Hold Public Meeting on Responsible Innovation in Dietary Supplements

by Shari Barbanel | April 22, 2019

The U.S. Food and Drug Administration (FDA) recently announced a May 16 public meeting entitled “Responsible Innovation in Dietary Supplements.” On Feb. 11, 2019, the FDA announced new efforts to strengthen the regulation of dietary supplements by modernizing and reforming its oversight. The purpose of the public meeting is to give interested parties an opportunity to present ...

Efficient Regulatory Structure Critical to Protecting Consumers and Public Health, says NPA

by Shari Barbanel | October 15, 2018

The Natural Products Association (NPA) has called for a streamlined and efficient regulatory structure to protect consumers and public health as the U.S. Food and Drug Administration (FDA) implements its “Comprehensive, Multi-Year Nutrition Innovation Strategy.” “NPA supports the goals of FDA in its plans for the Multi-Year Nutrition Innovation Strategy and its efforts to promote ...

UNPA Announces No-sale Policy for Liquid, High-dose Caffeine Products as a Condition of Membership

by Shari Barbanel | May 23, 2018

The United Natural Products Alliance (UNPA) has approved the adoption of a new, “no-sale” policy for liquid, high-dose caffeine products for retail sales. The policy is effective immediately as a condition of membership for prospective and all current UNPA members and joins a 2015 no-sale policy for bulk-powdered caffeine products. UNPA recommends that high-dose caffeine products not ...

AHPA Submits Vinpocetine Comments to FDA

by Shari Barbanel | November 21, 2016

The American Herbal Products Association (AHPA) recommends the Secretary of Health and Human Services (HHS) consider initiating rulemaking to declare vinpocetine to be lawful dietary ingredient in comments submitted to the U.S. Food and Drug Administration (FDA). AHPA also strongly encouraged FDA to clarify that if vinpocetine is either found to be currently in the ...

NPA Supports Lawful Marketing of Vinpocetine

by Shari Barbanel | November 8, 2016

The Natural Products Association (NPA) has submitted comments to the U.S. Food and Drug Administration (FDA) in response to the agency’s recent actions to ban vinpocetine. FDA is collecting public comments following a Federal Register notice that would effectively ban vinpocetine, a widely used product found in safe and legal dietary supplements. The FDA’s decision ...

FDA Considering Vinpocetine Ineligible as a Dietary Ingredient

by Shari Barbanel | September 9, 2016

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 ...

Industry Urges FDA to Define “Natural”

by Shari Barbanel | May 26, 2016

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 ...

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