U.S. Food and Drug Administration
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 ...
NSF Updates Pesticide Test Requirements for Supplements
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
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
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
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
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
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
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 ...
FDA, Stakeholders Meet, Mull Over Pre-DSHEA Dietary Ingredients List
On October 3, the U.S. Food and Drug Administration (FDA) held a public meeting to discuss the development of a list of pre-Dietary Supplement Health and Education Act of 1994 (DSHEA) dietary ingredients. According to a release from Washington, D.C.-based law firm Keller and Heckman LLP, the meeting featured two stakeholder panels that presented on ...
Lallemand Receives USP’s GMP Certificate for Canadian Production Facilities
Lallemand Health Solutions announced that both of its Canadian probiotic production plants in Montreal and Mirabel successfully passed the United States Pharmacopeia (USP) Quality Systems Good Manufacturing Practice (GMP) audit. The company thus has become the first probiotic production facilities to receive this quality certificate. “Such achievement illustrates our long-standing commitment to quality and demonstrates ...
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