MSMP training sites and areas of testing Clinical affiliate Genetics HID * Oncology Micobiology Affiliate 1 X X X X Affiliate 2 X X Affiliate 3 X Affiliate 4 X X X Affiliate 5 X X X X Affiliate 6 X Affiliate 7 X X X Affiliate 8 X Affiliate 9 X Affiliate 10 X Clinical R&D ([dagger]); affiliate new assays Affiliate 1 X Affiliate 2 X Affiliate 3 X Affiliate 4 X Affiliate 5 X Affiliate 6 X Affiliate 7 X Affiliate 8 X Affiliate 9 X Affiliate 10 X * Human identity testing
([dagger]) Research and development Areas of service provided at each laboratory are indicated by an "X" Table 4.
"He urged companies to seek out the proper analytical testing methods, rather than blindly approach identity testing
as a "one size fits all" endeavor.
Further, one company rejected by CTCA was cited by the FDA for inadequate ingredient identity testing
. In another case, third-party analysis showed that a medicinal mushroom product contained illegal and potentially toxic levels of melamine.
All testing is performed on-site at the DNA Identity Testing
Center and never outsourced to any third party.
He added that DNA testing is a "very powerful tool that should be used, and used correctly." Having made a significant investment in equipment and other resources, Alkemist will eventually be offering DNA analysis services, "because we do believe it plays a role in identity testing
in this industry." Still, other simpler, less expensive methods have been widely accepted around the world by other regulators and experts.
The scope of molecular testing in this core facility includes assays for genetic diseases, hematology, oncology, infectious diseases, and identity testing
. In addition, the laboratory's research efforts to identify molecular markers for human cancers provides the technical component of a Community Cancer Genetics Outreach Program.
USP GMPs include requirements of particular interest to retailers such as recall procedures, expiration dating supported by stability data, and identity testing
for all ingredients--not just dietary ingredients.
Food and Drug Administration (FDA) officials and herbal product experts provided industry leaders with insights and guidance on regulatory compliance, public relations, global market and supply trends, and botanical identity testing
technology at the American Herbal Product Association's (AHPA's) 2015 Botanical Congress in October.
We started with a narrow focus on botanical identity testing
. This was due to our low budget since we were self-funding, sequestering us in the low-tech side of the analytical lab business.
1) Industry should call on FDA to immediately issue a rule requiring all ingredient manufacturers and suppliers to be subject to the dietary supplement cGMPs, including but not limited to heavy metal, microbial and identity testing
(the Food Safety Modernization Act, FSMA, at this point is not addressing this issue as it should have).
Dietary supplement companies are required by law to adhere to Good Manufacturing Practices (GMPs), which include identity testing
for all botanical materials used, he added.
FDA's proposed language regarding supplier verification and product identity testing
could impose significantly more obligations on ensuring the safety and quality of dietary ingredients manufactured domestically as well as in foreign countries.