AHPA Updates

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.

Tamika Cathey, a former Food and Drug Administration (FDA) inspector and current independent regulatory consultant at EAS Consulting Group, discusses identity verification regulations and methodologies with the American Herbal Products Association (AHPA).
Cathey and 15 other industry experts will discuss botanical identity verification regulations, methodologies, and technologies at the AHPA Botanical Congress being held Saturday, Nov. 16, at SupplySide West in Las Vegas.

AHPA: What responsibilities do manufacturers have when it comes to verifying the identity of ingredients?

Tamika Cathey: The manufacturer has the responsibility to verify the identity of any dietary ingredient by at least one appropriate test or examination per 21 CFR 111.75 (a)(1). In some cases, a single test or examination may be all that is required, but other cases may require conducting more than one test or examination.