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U.S. Food and Drug Administration


FDA Asks for Consumer Input on Labeling Plant-Based Products, NPA Responds

by Shari Barbanel | October 4, 2018

The U.S. Food and Drug Administration (FDA) has issued a request for information as it examines its approach to the use of dairy food names like “milk,” “cheese,” or “yogurt” in the labeling of plant-based foods and beverages. Earlier this year, FDA Commissioner Scott Gottlieb announced FDA’s Nutrition Innovation Strategy (NIS) in a speech to the National ...

New Draft Guidance for Probiotic Labeling Could Yield Inaccurate Product Labels, CRN Says

by Shari Barbanel | September 24, 2018

The U.S. Food and Drug Administration (FDA) recently released a draft guidance entitled “Policy Regarding Quantitative Labeling of Dietary Supplements Containing Live Microbials” to advise firms that manufacture, market or distribute dietary supplements that contain live microbial ingredients of the conditions under which the FDA intends to exercise enforcement discretion to allow firms to declare ...

AHPA NDI Database Shows Increase of Recent Notifications Filed Successfully

by Shari Barbanel | August 27, 2018

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 ...

NSF Updates Pesticide Test Requirements for Supplements

by Shari Barbanel | August 14, 2018

NSF International and the NSF/ANSI 173 Joint Committee have updated the pesticide testing requirements included in NSF/ANSI 173, the only American National Standard for dietary supplements. A recent NSF study established chemical-specific pesticide limits for 185 pesticides that might be present in botanical ingredients used in dietary supplement ingredients. “The new testing requirements fill an ...

Study Questions Importance of Supplements, Industry Responds

by Shari Barbanel | May 30, 2018

Nutritional supplement industry associations have responded to a new study led by researchers at St. Michael’s Hospital and the University of Toronto, which suggests that the most commonly consumed vitamin and mineral supplements provide no consistent health benefit or harm, and says to rely on a “healthy” diet for vitamins and minerals. Published in the ...

USP Announces Updated Ingredient Verification Program

by Shari Barbanel | April 23, 2018

USP (United States Pharmacopeia) has updated its Ingredient Verification Programs (IVP), services that help companies ensure they meet quality standards for ingredients used in the manufacture of dietary supplements and drug products. USP has IVPs for dietary ingredients (IVP-DI), for excipients (IVP-E) and for active pharmaceutical ingredients (IVP-API). Manufacturers of finished dietary supplements and drug ...

Industry Applauds FDA Action on Highly Concentrated Caffeine

by Shari Barbanel | April 16, 2018

The U.S. Food and Drug Administration (FDA) recently took an important step to better protect consumers from the dangers of highly concentrated and pure caffeine products. These products present a significant public health threat because of the high risk that they will be erroneously used at excessive, potentially dangerous doses. Highly concentrated and pure caffeine, ...

Senator Hatch Announces Retirement

by Shari Barbanel | January 3, 2018

On January 2, the longest-serving Senate Republican, Senator Orrin Hatch of Utah announced that he would not seek re-election for an eighth term. Sen. Hatch, who formed and led the Dietary Supplement Caucus in the Senate, co-authored the landmark legislation that established a rational framework for regulating dietary supplements, the Dietary Supplement Health and Education ...

U.N.-affiliated Initiative Gets an Assist From Rivkin Radler

by Shari Barbanel | December 19, 2017

On December 12, 2017, the Island Women Open Network (IWON), created by the Sustainable Energy and Climate Resilience Initiative in partnership with the United Nations Industrial Development Organization (UNIDO), signed an agreement engaging New York and New Jersey-based Rivkin Radler LLP for legal assistance. IWON’s main objective is to empower women and children at the ...

New Study on SARMs Reaffirms Need for Enforcement Action and Consumer Awareness

by Shari Barbanel | December 4, 2017

On November 28, the Journal of the American Medical Association (JAMA), published a study online entitled, “Chemical Composition and Labeling of Substances Marketed as Selective Androgen Receptor Modulators (SARMs) and Sold Via the Internet.” In the study, researchers analyzed products that were labeled to be containing SARMs that are marketed on the internet. The researchers ...

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