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The American Herbal Products Association (AHPA) submitted nearly 200 pages of comments and suggested revisions to the Food and Drug Administration (FDA) in response to the first two proposed rules issued to implement portions of the FDA Food Safety Modernization Act (FSMA)
The rules that FDA first proposed on January 16, 2013, would create new regulations for human food manufacturers (Current Good Manufacturing Practice (cGMP) and Hazard Analysis and Risk-Based Preventive Controls for Human Food) and subject certain farming activities to risk-based standards (Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption).
AHPA President Michael McGuffin addresses Botanical Congress attendees
The American Herbal Products Association (AHPA) held its 2013 AHPA Botanical Congress: Practical Approaches to Verifying Identity on November 16 in conjunction with SupplySide West in Las Vegas.
The full-day event convened supplement industry veterans to provide industry stakeholders, including ingredient suppliers and product manufacturers, with information about how to comply with U.S. dietary supplement current good manufacturing practice (cGMP) regulations (21 CFR 111). Experts provided information on finished-product testing and verification of botanical ingredients' identity using "scientifically valid" methods. The event also featured roundtable-style discussions with legal and regulatory experts and interactive, hands-on activities focused on identity testing methods and technologies.
SH, Second Edition also being translated into Japanese
A second printing of the American Herbal Products Association (AHPA) Botanical Safety Handbook, Second Edition has been issued and is now available to meet the growing demand for botanical safety information. Arrangements are also being made to publish a Japanese translation of the handbook in 2015.
The handbook, available in hardcover and digital versions, is an authoritative compilation of safety information from clinical trials, pharmacological and toxicological studies, medical case reports and historical texts on over 500 species of commonly used herbs. This resource provides information about effectiveness, adverse side effects, drug interactions, and standard dosing of popular herbal supplements. The information is organized into easy-to-use classification systems that rate the safety and potential for drug interactions of each species to make this complex information accessible to anyone.
American Herbal Product Association (AHPA) President Michael McGuffin wrote a letter to the editor criticizing inaccuracies in a recent article, " DNA barcoding detects contamination and substitution in North American herbal products," published in BMC Medicine
Despite confusing conclusions and questionable methodology, the article sparked alarming headlines across the country about the prevalence of contamination in supplements after the New York Times summarized the BMC Medicine report in an article published on Nov. 3. AHPA is contacting newspapers that covered the BMC Medicine article to inform them about the significant issues that undermine the article's credibility.
Before being cleaned, treated and processed for sale, an estimated 6.6 percent of spices imported to the U.S. between fiscal year (FY) 2007 and FY2009 had a prevalence of Salmonella and roughly 12 percent were contaminated with filth like insect parts, whole insects, rodent hairs, dirt and other matter, according to a draft risk profile released Oct. 30 by the Food and Drug Administration (FDA).
The numbers in the risk profile sparked sensational headlines, but several caveats noted in the profile make these numbers less alarming.