SoCal Dietary Supplement Consortium (SCDSC) remains one of my (Nick Crowning’s) favorite conferences to attend. For those who don’t know, SCDSC’s unique structure allows FDA to attend, give presentations, and interface directly with industry.

This year, FDA presented on the preamble to 21 CFR Part 111, an often overlooked but invaluable resource for anyone looking for regulatory guidance, particularly for specifications, as it contains the FDA’s definition of an interpretation of strength, purity, and limit of contamination specifications. It can be found here – https://www.govinfo.gov/content/pkg/FR-2007-06-25/pdf/07-3039.pdf

FDA also stressed the need for scientifically valid methods, for both botanical identity and microbiology. On the botanical identity front, specificity is of upmost importance. Using fast and cheap method like FTIR may give a passing result, but lack specificity required for the method to be scientifically valid. For microbiology, it is critical to confirm your method through matrix spiking, and to understand the inherent risks of each ingredient. There is no ‘one size fits all’ approach to microbiology, and FDA will expect you to understand your own products and conduct testing accordingly.

The session ended with another important topic – strength and purity of botanical finished products.  The key takeaway is to not write yourself into a corner with these specifications.  Alkemist has vast experience testing multi component finished goods, even those containing herbal powders without standardizations to marker compounds.