Without more resources, FDA can’t conduct enough inspections to get an accurate picture of the marketplace, highlighting the importance of self-regulation.
At the 12th annual Legal, Regulatory, and Compliance Forum on Dietary Supplements, FDA and FTC officials, and lawyers discussed a grab bag of hot topics.
The brief continued to argue that a preliminary injunction should prevent New York’s supplement age restriction from going into effect until the lawsuit ends.
The U.S. Chamber of Commerce, Consumer Healthcare Products Association, Food Marketplace Inc., and the National Association of Chain Drug Stores voiced support.
The appeal challenges interpretations which led to the recent U.S. District Court decision to let the law go into effect ahead of the lawsuit’s conclusion.
The latest of what will be several guidance documents on the NDI process provides updates on the agency’s proposed method to handle proprietary information.
While the study didn't include calcium supplementation, it was nonetheless "striking" that vitamin D alone made no difference, according to the authors.
Due to “competing priorities,” the agency provided no clarification on how it interprets the provision of DSHEA which defines drugs versus dietary ingredients.
The guidance, issued this year is a departure from common marketing practice of dietary supplements and food, and misrepresents the state of the law, CRN said.
Following an update from the agency, the trade association characterized the agency’s plan as ‘pulling back’ on its responsibility to regulate supplements.
While variety in food patterns implies diverse nutrient needs, few of hundreds of prenatal supplements assessed were suitable for 90% of pregnant participants.
President and CEO of the Council of Responsible Nutrition discussed the industry’s need to strengthen communications, self-regulation, and transparency.
According to product recall reports, just a portion of products containing illegal ingredients were recalled following the issuance of warning letters.
Amnesty for late NDI notifications is intended to encourage manufacturers and distributors to correct past failures while collecting safety data, FDA said.
Industry should view both proposed legislation and arguments against it with a critical eye, but let’s address legitimate concerns while dismissing strawmen.
By Steve Mister, President & CEO, Council for Responsible Nutrition04.26.22
Sen. Dick Durbin (D-IL) and Sen. Mike Braun (R-IN) introduced a bill that would require dietary supplement manufacturers to file product information with FDA.
Utah’s longest-serving Senator was known for working across the aisle, authoring or coauthoring some of the most consequential laws of the past half century.
The U.S. Food and Drug Administration is prioritizing multiple ways to regulate the dietary supplements industry in its request for an $8.4 billion budget.
Trial finds modest reduction in cardiovascular events for those taking cocoa extract, no association between multivitamins and reduced risk of cancer or CVD.
The agency has called into question the amino acid metabolite’s legal status as a dietary ingredient, counter to the opinions of several industry leaders.
Following a review of the evidence, FDA now supports three types of claims on the research, which it still considers to be “inconsistent and inconclusive.”
After issuing warning letters to companies claiming that NAC is excluded as a dietary ingredient, the agency's response to citizen petitions is still tentative.
Wommack, who currently serves as CRN’s senior vice president, will follow the foundation’s plan to prioritize access to nutritional products and education.
FDA raised objections to the use of N-acetylcysteine in supplements in Dec. 2020, and since, Amazon has pulled all NAC-containing products from its platform.
Focus centered around the GRAS and NDI processes, the prospects of a mandatory product listing, how health claims will be handled in the future, and more.
Promotions include Holly Vogtman to director of communications, Rashidah Denton to manager of scientific and regulatory affairs, and Gretchen Powers’ expanded role to include member experience.
While the agency has not specifically confirmed it, dietary supplements were not mentioned in a list of manufacturers required to enhance traceability measures.
Ridley’s responsibilities will be to spearhead the association’s communications program, build key partnerships, and craft education and advocacy campaigns.
FDA currently prohibits the use of NAC as a dietary supplement, and is concerned about a proposal for HHS to review certain regulations or let them expire.
Both the Council for Responsible Nutrition and the BBB’s National Advertising Division are optimistic about the industry’s ongoing self-regulatory efforts.
This consumer resource explores the harm that increased exposure to electronic lighting does to eye health, and what can be done to mitigate this damage.
The organization’s former senior vice president, scientific & international affairs, was a leader in the dietary supplement industry during his 17-year tenure.