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AHPA NDI Database shows 15 of 59 most recent NDI notifications acknowledged by FDA without objection

18 NDI notifications were considered incomplete

Fifteen (or roughly 25 percent) of the 59 New Dietary Ingredient (NDI) notifications submitted to the Food and Drug Administration (FDA) between November 2015 and October 2016 were acknowledged without objection, according to the latest data uploaded to AHPA's NDI Database.

IADSA update on international supplement regulations

IADSA December 2016 Newsflash

This issue of the IADSA Newsflash includes an update on the Association of Southeast Asian Nations (ASEAN) Agreement on Regulatory Framework for Health Supplements deadline for implementation, which will be pushed back to March 2023.

FDA Inspections, Warning Letters and Emerging cGMP Compliance Issues

Learn the elements of 21 CFR 111 / current Good Manufacturing Practice (cGMP) regulations that FDA inspections have been focusing on recently

Webinar recorded Dec. 13, 2016. Member cost: $199. Nonmember cost: $499.

AHPA submits comments to DEA on potential impacts of scheduling herbal constituents

DEA should avoid restricting research on new medical uses, health benefits, or other uses for botanicals

In comments submitted last week to the Drug Enforcement Agency (DEA), the American Herbal Products Association (AHPA) urged the agency to refrain from using its authority to effectively remove a plant from the existing marketplace because naturally occurring constituents become scheduled under the Controlled Substances Act (CSA).

AHPA submits comments to FTC regarding consumer perceptions of "organic" claims

Many personal care products and dietary supplements are produced in compliance with USDA's National Organic Progam

AHPA stressed that non-food products, including personal care products, may be agricultural products that can comply with the United States Department of Agriculture (USDA) National Organic Program (NOP).

"Incidental DNA fragments" may be misinterpreted using Next Generation Sequencing (NGS)

A caution to industry and regulators

This article, "A caution to industry and regulators - 'Incidental DNA fragments' may be misinterpreted using Next Generation Sequencing (NGS)," is authored by Dr. Steven Newmaster, Professor, Botany & Genetics/Genomics at the University of Guelph, Dr. Subramanyam Ragupathy, Senior Scientist, NHP Molecular Diagnostics at the Biodiversity Institute of Ontario, and Dr. Robert Hanner, Chief Technology Officer (CTO) at TRU-ID Ltd. These leading DNA experts detai challenges and pitfalls of DNA analysis used to verify the identity of herbal ingredients.

California Prop 65 Webinar: A Status Update

Companies selling products in California should understand recent and developing Prop 65 changes

Recorded November 16, 2016. Member cost: $220. Nonmember cost: $520.

FDA Seeks Comment on Tentative Conclusion that Vinpocetine Is not a Dietary Ingredient

FDA maintains vinpocetine is a synthetic compound

A Food and Drug Administration (FDA) notice scheduled to be published tomorrow in the Federal Register requests comments on the agency's tentative conclusion that vinpocetine is not a dietary ingredient and is excluded from the definition of a dietary supplement.

Report from the 2016 Conference of Western Attorneys General Annual Meeting

By Douglas F. Gansler

In January, AHPA and UNPA launched a joint campaign to develop working relationships with state attorneys general (AG) and educate them about the herbal supplement industry to ensure they have an accurate understanding of the industry. Former Maryland Attorney General  and Past President of the National Association of Attorneys General. Gansler was hired to help deliver information and expertise about the industry to his colleagues.

FDA Releases Revised Draft of NDI Guidance

Revised draft replaces FDA’s 2011 draft

The Food and Drug Administration (FDA) today released revised draft guidance for new dietary ingredients (NDIs) to be published in the Federal Register on Friday. The revised draft replaces FDA’s 2011 draft.
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