Since 2009, the Food and Drug Administration has mandated that a nutritional supplement manufacturer test their raw materials for authenticity, potency, microbiology contamination and stability. However, these regulations allow manufacturers to perform “skip lot testing”, which means only a fraction of the raw materials will be tested, since manufacturers are allowed to test at whatever frequency they set forth in their operating procedures. Manufacturers may justify this tactic by relying on certificates of analysis for their raw materials and by qualifying vendors based on past performance.
Skip lot testing may seem appealing as a cost saving measure – after all, testing every single batch of raw material and finished product is both labor and time intensive, can prolong manufacturing time, and generates a tremendous amount of paperwork. But is skip lot testing adequate? Are the potential savings worth the risks?
Vital Nutrients has always quarantined and tested every batch of raw material received, using independent third party labs.
By refusing to perform skip lot testing, VN has discovered instances of incorrect identity and potency and even microbial contamination. Therefore, we are able to reject unacceptable raw materials prior to manufacture, eliminating any risk of harm to the consumer, as well as the financial risks of performing recalls for product that is out of specification. The most common reasons for such recalls are “undeclared allergens, mislabeling, the presence of contaminants, questionable stability, and incorrect potency.”
For instance, it’s not uncommon for a raw material supplier to supply the wrong plant material! Through identity testing at the genus and species level, using thin layer chromatography by a specialized lab, VN has been able to correctly identify and reject false materials. In one such case, a Coptis Extract raw material (a Berberine-containing herb used in immune formulas Herbal Biotic and Viracon) was found to contain inadequate plant material, and instead to be spiked with Berberine. Lab analysis showed 83.8% Berberine instead of the normal range 6-10%, and the material was rejected.
Potency is the most common reason for rejection of raw materials.
For instance, VN has rejected 90% Chondroitin that tested at 16%, 100% Berberine that tested at 85.2%, and Bromelain that was 50% subpotent. Using subpotent materials can result in an ineffective treatment plan, and begs the question as to what the material has been ‘cut’ or adulterated with –in the case of Bromelain, it’s often lactose, which can cause adverse events in intolerant patients. Superpotent products can also increase the risk of adverse side effects.
Microbiology testing is performed on every raw material and finished product for total aerobic bacterial count, yeast and mold counts, and pathogenic bacteria; including Salmonella spp, E. coli, Enterobacter, Pseudomonas aeruginosa, and Staph aureus. This testing is crucial to a patient’s safety. In one instance, a Leucine raw material with high yeast and mold count was rejected. This testing is especially critical for probiotics, to ensure they contain the species claimed on the label and exclude pathogenic microorganisms.
In summary, although skip lot testing is far less expensive, requiring less labor, shorter time to manufacture and less paperwork, any company that actually tests every receipt of raw material knows that certificates of analysis are often inaccurate, whether through fraudulence or honest error. While it may be less likely or less common to receive misidentified, subpotent, superpotent or contaminated material from a familiar wholesaler with an excellent reputation, it certainly is not impossible.