Issue link: https://www.e-digitaleditions.com/i/626800
Tablets & Capsules January 2016 32C Outside help Regardless of a manufacturer's product line and its busi- ness philosophy, by law it must test and authenticate the ingredients it uses [3]. Ingredient suppliers like Sabinsa also conduct tests. "Every batch of incoming raw material as well as finished product undergoes a series of tests to verify compliance to the specification of the material," Majeed said. "Similarly, the processing stages are monitored for quality and to identify and correct any possible deviation." The company also grows some of its own botanical ingredi- ents and thus exercises greater control over quality. Because testing is expensive and sometimes complicated, many companies rely on third- party laboratories, such as Covance. "We work with our clients to ensure that their raw materials and finished prod- ucts are safe and free of adulterants," Mastovska said. "It's for their own protection and the protection of the supply chain." Best Formulations combines in-house and outside test- ing. "We have extensive in-house laboratory capabilities that cut down on testing costs and lead times tremen- dously," Ung said. "But because we manufacture so many dosage forms from thousands of different materials, we sim- ply are not able to test every single ingredient in-house." DNA bar-coding One of the most discussed test methods uses DNA— more specifically, an organism's unique genome—to identify ingredients. DNA bar-coding gained notoriety last year when Eric Schneiderman, New York attorney general, used it to support an enforcement action against four major retail- ers. But many people question the suitability of the test. "Experts in the natural product industry are still debating the pros and cons of DNA technology, even while trying to find ways to make it work across a broad range of products for which there are no agreed-upon primers and sequences," Majeed said. "We find that DNA technology, while being very useful in authenticating raw material, is not the solu- tion to all the problems of ingredient authentication that the industry is currently facing." Even when applied to the nutraceuticals it can reliably identify, DNA testing is quite complex and requires specialized knowledge in order to administer the test correctly. In an April 2015 article, Danica Renaud, chief executive officer and chief science officer of AuthenTechnologies, Richmond, CA, said that performing DNA testing on botanical ingredients requires understanding botany and the nature of DNA in finished dietary supplement products. Finished dietary supplement products do not tend to have DNA left in them, she said, and if they do, it's not very good quality. That can lead to false-negative results. In the same article, Roy Upton, executive director for the American Herbal Pharmacopeia said that DNA bar- coding cannot reliably identify the ingredients of botanical extracts. Extracts are made by a process that either does not preserve DNA or alters its characteristics, so DNA testing of an extract is inappropriate. Other drawbacks include the test's inability to detect heavy metals and other non-biologi- cal contaminants and its lack of quantitative information about the contaminants it does detect. "For someone to come out and say the end-all, be-all test is DNA bar-coding is a little presumptuous," Ung said. "It lacks understanding of the science and what's behind these products. We're not trying to make excuses. The fact is that it does not make sense to apply DNA testing to every dietary supplement product, because it is simply not applic- able to everything." Third-party certification In addition to testing, many suppliers and manufacturers opt for third-party certifica- tions. Although they are not officially recognized by the FDA, they promote a uniform approach to testing and other practices. "The Agency is working with these third-party auditors in getting comments and feedback from the indus- try," Ung said. "We're all trying to get on the same page and interpret the regulations the same way so that there are effi- ciencies and we are not doing the same thing four different ways." NSF International, Ann Arbor, MI, is among the organi- zations offering a nutraceutical certification program. It includes reviewing label claims to certify that a product's content matches what's listed on the bottle; conducting a toxicology review; and testing to ensure the product is free of undeclared ingredients and/or unacceptable levels of con- taminants. While quality cannot be tested into products, enforcing the law should diminish the number of bad actors. "Testing on the enforcement side will help," Mastovska said. "If you have more testing overall, people will know they can get caught." Ung also expressed optimism. "Over the last few years, the reputable material suppliers have come to understand transparency is required in a successful supply chain relation- ship," he said. "This sort of communication and understand- ing amongst the raw material manufacturer, material distrib- utor or supplier, contract manufacturer, and the brand owner have certainly improved tremendously. More transparency and trust helps breed efficiencies." T&C References 1. What's New Related to Drugs. Last modified Dec-ember 16, 2015, http://www.fda.gov/Drugs/NewsEvents/ucm130958.htm. 2. FDA takes action to protect consumers from potentially danger- ous dietary supplements. Last modified November 17, 2015, http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm 473099.htm. 3. FDA, 21 CFR Part 111. Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. Further reading Ingredient identity testing: The road to GMP compliance. Mara Whitten. Tablets & Capsules 9 (4) pp. 32C-32E. What standard? Investigation raises questions about DNA testing. Evan Hansen. Tablets & Capsules 13 (3) pp. 32B-32E. Third-party certification has helped the industry move toward establishing standards for which tests to use.