Among the headlines this week were Trump’s nomination for new FDA Commissioner, NOW retesting SAM-e supplement brands on Amazon, France’s new proposals for maximum levels for vitamins and minerals, and industry reaction to India’s list of recommendations to regulate nutraceuticals.
USA: NOW retests SAM-e brands and finds persistent quality problems
Illinois-based natural products manufacturer NOW reported that “profound quality and labeling failings continue” after its latest round of dietary supplement testing found that 20 of 24 SAM-e samples purchased on Amazon failed potency tests.
This is the second time the company has analyzed SAM-e dietary supplements after its March 2020 testing revealed that all 11 products tested were of low potency, and two of those found to contain none of the active ingredient whatsoever.
NOW decided to revisit SAM-e category, purchasing a new round of samples from more brands to see if any brands corrected their false labeling claims.
Loren Israelsen, president and founder of the United Natural Products Alliance (UNPA), described the results as “extremely disappointing”.
“We fully support NOW’s work to give us a continuing idea of the level of non-compliant products on Amazon,” he added. NOW is a member of UNPA," he said.
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India: Inter-ministerial committee report receives mixed industry response
An inter-ministerial committee from India has put forth a list of recommendations on how nutraceuticals could be regulated, which has received mixed industry response, especially around disease risk reduction claims.
The 20-page report looked at existing regulations across a wide range of nutraceuticals, including vitamins, minerals, amino acid supplements, Foods for Special Dietary Uses (FSDU), Foods for Special Medical Purposes (FSMP), prebiotics, probiotics and botanicals.
The industry’s preference is to stick with the existing framework, with the FSSAI continuing to assess clinical evidence for disease risk reduction claims.
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USA: Dietary supplements industry reacts to Dr. Marty Makary’s nomination for FDA Commissioner
Dietary supplement trade associations have issued optimistic responses to the news of the nomination of Johns Hopkins surgeon Dr. Martin “Marty” Makary for commissioner of the Food and Drug Administration.
The nomination was announced by President-elect Trump via a post on Truth Social.
In response, Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), said: “We are eager to collaborate on ways to find regulatory efficiencies within the Dietary Supplement Health and Education Act (DSHEA), ensuring it continues to serve consumers effectively in today’s marketplace. At the same time, we welcome opportunities to engage with the FDA on strengthening oversight and maintaining the highest standards for dietary supplements and functional nutrition products.
“We are optimistic that under Dr. Makary’s leadership, the FDA will foster innovation while maintaining a commitment to safety, transparency, and accountability. CRN stands ready to partner with the FDA to advance policies that benefit consumers and the industry alike.”
To read more responses from the United Natural Products Alliance (UNPA) and the Consumer Healthcare Products Association (CHPA), please click HERE.
Europe: France proposes sweeping changes to maximum levels for vitamins & minerals
French regulators of food supplements are proposing significant changes to permissible levels for vitamins and minerals in food supplements, which could see vitamin C limits slashed by almost 80%.
Maximum levels for vitamins and minerals (MPL) in food supplements and other foods are set individually by EU Member States. While there exists an EU working group that is exploring the potential to harmonize the levels, there is still no agreement at the EU levels, and France is now pushing forward with some significant changes.
Among the proposals is a significant reduction in the limit for Vitamin C, which could be dramatically reduced from 1,000 mg to 208 mg, representing a decrease of 79.2%.
Among the B vitamins, France is proposing to reduce the maximum permitted level (MPL) for Vitamin B6 by almost 25%, from 12.5 mg to 9.4 mg. New limits of 2.4 mg, 3.6 mg, and 10.6 mg are also proposed for Vitamins B1, B2, and B6 respectively. There were previously no MPLs for these vitamins. For Vitamin B12, a new 14 microgram limit is being proposed, which is extremely low considering Italy’s limit of 1,000 micrograms.
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