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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.
   

Color additive regulations expand the permitted use of spirulina extract (Federal Register)

Editor's Note: The FDA has confirmed the effective date as September 22, 2015, for the Final Rule that amended the color additive regulations to expand the permitted use of spirulina extract as a color additive to include use in coating formulations applied to dietary supplement and drug tablets and capsules. FDA received no objections or requests for a hearing on the final rule. 

GNC issues response to Oregon AG lawsuit (GNC)

Editor's Note: GNC issued the statement below noting that the lawsuit filed by the Oregon Attorney General is "without merit" and that the company will "defend itself vigorously against this unfair action."

AHPA Provides Perspective on Emergency Room Visits Purportedly Associated with Supplements

When placed into context, study demonstrates relative safety of supplements

Article published in New England Journal of Medicine

overstates emergency room (ER) visits associated with dietary supplements. Study also shows supplements are relatively safe compared to other product categories.

AHPA urges USP to use more precise terminology in proposed general chapter

AHPA Update

AHPA expresses concern that USP's proposal confuses unlawful misbranded drugs with legal dietary supplements

AHPA Revises Guidance on Prop 65 Warnings for Pulegone

Does Naturally Occurring Pulegone Represent 'Exposure' Under CA Prop 65?

AHPA has updated guidance to help members understand and comply with California Proposition 65 requirements when selling products that contain pulegone, a ketonic monoterpene that is a naturally present constituent in various plant species, including mints.

Limitations of DNA testing for botanical identification

DNA analysis can generate false negative results due to the normal and expected lack of DNA in some processed herbal ingredients

The statement provides the view of the American Herbal Products Association of the current state of the science of the use of DNA barcoding as a technique for authenticating the identity of herbal materials for this purpose and is intended to explain any misunderstandings that may arise out of the March 30 agreement as to the currently limited applicability of this analytical technique.
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