Legal Alert - American Herbal Products Association (AHPA)

Technical Workshops

AHPA regularly presents in-person technical workshops to train the herbal products industry on the latest tools and methods that help ensure high-quality products and compliance with federal and state regulations.

Upcoming 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. 

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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."
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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.
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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.
Author: AHPA Staff
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AHPA Adopts Policy Against Sale of Bulk Caffeine

Recent reports associate serious injury and death with use of pure caffeine purchased by consumers in bulk packaging.

The American Herbal Products Association (AHPA) Board of Trustees on March 4 established a trade requirement that prohibits sale by AHPA members of pure caffeine in bulk form at retail (to consumers).
Author: AHPA Staff
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Whitepaper on DNA barcode testing reveals how misapplication of science led to baseless results

The Capabilities and Limitations of DNA Barcode Testing

A comprehensive analysis of DNA barcode testing on botanical dietary supplements has called conclusions reached by the New York Attorney General’s (NY AG) office in an investigation of four major retailers of botanical supplements, a “…misuse of the technologies” that led to a “…misinterpretation of test results.”
Author: AHPA Staff
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Contract Manufacturers and their Customers: Best Practices for Effective Partnerships

Presented November 13, 2014

Dietary supplement contract manufacturers and their “own-label distributor” customers must navigate a host of issues in order to establish effective business partnerships that ensure quality and compliance with federal laws and regulations
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AHPA issues cannabis oversight recommendations for regulators

Oversight framework promotes best practices for cannabis production and distribution from seed to consumption

The American Herbal Products Association (AHPA) has published recommendations for regulators to address issues related to the safe use and responsible commerce of legally-marketed products derived from Cannabis species.
Author: AHPA Staff
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Federal judge approves consent decree with New York dietary supplement maker (FDA)

A federal judge in New York has signed a consent decree for permanent injunction between the United States and Mira Health Products Ltd., a dietary supplement manufacturer located in Farmingdale, New York, and Michael S. Ragno and Michael S. Ragno, Jr.
Author: AHPA Staff
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FDA Inspections & Emerging cGMP Compliance Issues

Presented May 15, 2014

Tips for handling every aspect of a Food and Drug Administration (FDA) inspection--from pre-inspection preparation to interacting with on-site inspectors--and how to respond to observations and warning letters
Author: AHPA Staff
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