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International Alliance of Dietary/Food Supplements Associations (IADSA) December 2015 Newsflash

The latest international supplement regulation news from IADSA

AHPA is an active member of IADSA and distributes the IADSA Newsflash as a member benefit. IADSA is an association focused on the globalization of food supplement markets and regulatory challenges.

US Marshals seize dietary supplements containing kratom (FDA)

Legal Alert

The U.S. Department of Justice, on behalf of FDA, filed a complaint in U.S. District Court alleging that kratom is a new dietary ingredient (NDI). An FDA spokesperson said that FDA has identified kratom as a substance that could pose a risk to public health and the agency will use its authority to take action on products containing this alleged NDI.

Global warming and botanicals (Nutrition Business Journal)

AHPA Market Alert

Editor's Note: "We are entering a new era of weather. And the forecast for ingredient supply is changing just as fast," writes AHPA Member Bill Chioffi in Nutrition Business Journal. Chioffi illustrates how extreme weather caused by global warming can impact the supply of certain botanicals. Because botanicals are often grown in geographical niches particular to the plants and the cultures that produce them, the impact of climate change is likely more complicated than for all other commodity crops, according to Chioffi.

Industry Associations Welcome Elevation of Division of Dietary Supplement Programs to 'Office' within FDA

Press Release

The five trade associations representing the dietary supplement industry today welcomed the elevation of the Division of Dietary Supplement Programs (DDSP) to an "Office" status within the Food and Drug Administration's (FDA) Center for Food Safety and Applied Nutrition (CFSAN).

Effect of Resveratrol Treatment on the Pharmacokinetics of Diclofenac in Healthy Human Volunteers

Science Alert

This limited study assessed the effect of resveratrol on the pharmacokinetics of diclofenac, the nonsteroidal anti-inflammatory drug, in 12 healthy human volunteers

Goldenseal and Aloe vera "non-decolorized whole leaf extract" added to California Proposition 65 list

AHPA Update

Companies generally have one year to ensure products comply with new Proposition 65 requirements

FDA posts final import and produce regulations to implement FSMA (FDA)

AHPA Legal Alert

The final rules establish enforceable safety standards for produce farms -- Produce Safety rule -- and make importers accountable for verifying that imported food meets U.S. safety standards -- Foreign Supplier Verification Programs (FSVP) rule. FDA also issued a rule establishing a program for the accreditation of third-party certification bodies, also known as auditors, to conduct food safety audits of foreign food facilities -- Accredited Third-Party Certification rule.

FDA solicits comments on use of "natural" on food labeling (FDA)

AHPA Legal Alert

In response to four Citizen Petitions and the evolution of food ingredients, the Food and Drug Administration (FDA) is soliciting comments on the use of the term "natural" on food labeling.

Former FDA official calls for new regulatory framework for dietary supplements

Editor's Note: Former FDA official Joshua Sharfstein is calling for a new regulatory framework for dietary supplements. In an article published in Drug Testing and Analysis, Sharfstein and his co-author, Akshay Kapoor, allege that the regulation of dietary supplements has not kept up with changes and risks in the market, which has ultimately led to policy gridlock. He proposes a conceptual shift from 'benefit versus risk' to 'access with safety,' which includes registration of all dietary supplements, a disclaimer on the limited role of FDA in evaluating product claims, standardized laboratory techniques, and clearer authority for the agency when safety concerns arise.

Cannabinoids for Medical Use: A Systematic Review and Meta-analysis (JAMA)

Editor's Note: This review and analysis of cannabinoids for medical use found moderate-quality evidence to support the use of cannabinoids for the treatment of chronic pain and spasticity. There was low-quality evidence suggesting that cannabinoids were associated with improvements in nausea and vomiting due to chemotherapy, weight gain in HIV, sleep disorders, and Tourette syndrome. Cannabinoids were associated with an increased risk of short-term adverse events.
   

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