Issue link: https://www.e-digitaleditions.com/i/626800
O 32B January 2016 Tablets & Capsules ingredients Defending against adulteration Karina Basso Associate Editor Adulteration continues to plague the dietary supplement industry, but widespread testing and and rigorous enforcement of the law are turning the tide. n November 19 last year, the FDA issued public notifica- tions informing consumers that 10 "natural" weight-loss and sexual-enhancement products contained undeclared active pharmaceutical ingredients (APIs) [1]. That same week, the Agency summarized the results of a yearlong sweep of dietary supplements, including "civil injunctions and crimi- nal actions against 117 various manufacturers and/or distrib- utors of dietary supplements and tainted products falsely marketed as dietary supplements" [2]. In fact, the FDA discovers API-tainted dietary supple- ments nearly every week, creating a drumbeat of bad news that tarnishes the industry's reputation. "Many of the chal- lenges facing the nutraceutical industry today can be traced back to supply chain issues," said Shaheen Majeed, market- ing director at Sabinsa, East Windsor, NJ. His company manufactures, supplies, and markets dietary supplements, minerals, herbal extracts, and cosmeceuticals. The problem, he said, festered even after passage of the Dietary Supplement Health and Education Act (DSHEA) in 1994. "DSHEA didn't require GMPs for ingredient suppliers, so a lot of manufacturers began buying by price alone, often from brokers who aggregated ingredients from a variety of sources. Some companies were notorious for buying the cheapest ingredients they could find; some companies still practice this today." While focusing on low price or disregarding the possi- bility of adulteration makes sense to people who seek short- term profits and are willing to skirt the law, legitimate com- panies suffer. "For those manufacturers who play by the rules, adulteration of dietary supplements is a very negative issue because it casts a shadow of doubt on the whole nutraceutical industry," said Katerina Mastovska, associate scientific director at Covance Laboratories, a contract research laboratory based in Madison, WI. "That's why test- ing and monitoring of a supplement's contents is so impor- tant to protecting the brand of those who manufacture and sell these nutraceutical products." Mastovska said there are two types of adulteration: replacing natural ingredients with cheaper botanical substi- tutes and adding APIs to natural ingredients. "When you are looking at the broad effects of both types of adulteration, you can clearly see that [using cheap materials] is cheating consumers and [using APIs] can cause these very same con- sumers serious and sometimes fatal health effects." Preventing adulterated ingredients from entering a man- ufacturer's supply chain requires vigilance, said Eugene Ung, chief executive officer of Best Formulations, City of Industry, CA. His company provides contract formulation, production, and packaging of dietary supplements and pharmaceuticals. "Sometimes you get clients who will say, 'Hey, I've got this herb that I'm sourcing myself and I'm going to supply it to you as our nutraceutical's raw ingredi- ent,'" he said. "We try to screen as best as we can to deter- mine who these clients are. Are they new to the industry? What product are they making?" Product type makes a dif- ference, because the majority of adulteration is found in weight-loss, sexual-enhancement, and muscle-building sup- plements. "We tend to be conservative with the types of nutraceu- ticals we choose to manufacture," Ung said. "We're not known for making many weight-loss products or or sexual- enhancement products." Others don't take that view, he said. "Sometimes the manufacturer may know and they close their eyes and do it anyway. However, sometimes the manufacturer may not know; they're simply trusting that this client is sending them legitimate material. It's a business decision. Do you want to take on these type of business opportunities?"