With political turnover and the pending retirement of long-time allies like Senator Tom Harkin (D-IA), the industry needs new champions, Dr. Fabricant said. At SupplySide West, NPA hosted a reception in honor of Sen. Dean Heller (R-NV), who currently sits on the Commerce, Science, and Transportation Committee, which addresses many concerns related to the natural products industry. With about 12 Senate seats being contested in November, some big races could have a huge impact, said Mr. Fabricant, who went on to note many challenges to the industry and offered his expectations from a regulatory affairs point of view.
Regulation & Enforcement
FDA ramped up enforcement during Dr. Fabricant’s tenure and he said he expects more of the same as the agency continues to focus on GMP inspections and evaluating quality control systems of product manufacturers. He predicted the next 3-5 years will see increased enforcement actions and more cases brought forward against GMP violators and companies marketing dangerous, illegal products.
With enhanced tools provided by the Food Safety Modernization Act (FSMA), the agency is in better position to monitor and enforce supplement regulations when necessary, he added. Foreign supplier verification and HACCP systems for ingredients used in foods and supplements will be important tools for companies to understand.
Other areas of interest this year included Nutrition Facts Labeling, the Institute of Medicine’s report on caffeine in food and supplements, Nanotechnology guidance and new Gluten-Free regulations.
Moving forward, FDA may revisit the process for GRAS determination and ingredient safety. “FDA is not a fan of that process,” said Dr. Fabricant. “It could be a big game changer for those selling GRAS ingredients.” Meanwhile, questions regarding the New Dietary Ingredient Notification Process continue to persist. Can companies submit one Master File application to cover a broad range of products? What about “synthetic botanicals” and how are those defined?
Overall, “the point of the notification process was to give the agency a heads up when something new was added to the food supply,” said Dr. Fabricant.
Highlighted most recently by the case of an unapproved synthetic stimulant—1,3-Dimethylbutylamine, or DMBA—found in 12 dietary supplements, the agency is focused on at-risk categories like sports nutrition/body building, and weight loss. “If you’re making new compounds and you haven’t notified the agency, that’s technically adulteration,” Dr. Fabricant said.
The FTC has also been very active of late, bringing cases against Pom Wonderful and more recently Bayer over the marketing of its Phillips’ Colon Health probiotics supplement. The government contended that Bayer needs randomized, controlled, clinical trial (RCT) studies for the product for every probiotic strain.
In an amicus brief field with the U.S. Supreme Court and the U.S. Attorney’s Office for the District of New Jersey, NPA argued, “There is no legal basis at present for the government to require one or multiple RCTs as the only accepted form of evidence for claim substantiation.”
In a statement, Dr. Fabricant said, “NPA is very concerned that the government is using consent orders to effectively re-write federal law on dietary supplements. It’s important to point out that consent orders, which are meant to be case specific, may have unintended consequences for consumers if applied across the industry. Those include not just increased costs, but also the possibility of the reduced quality and quantity of information about products available to consumers. We urge the court to carefully consider this case and recognize that the outcome could result in major consequences for consumers, retailers and manufacturers of dietary supplements.”
Finally, like attempts to define “natural,” Dr. Fabricant said he doesn’t expect the contention over GMOs and labeling to be resolved any time soon. States have been very active, he added, as Vermont passed legislation in April to mandate GMO labeling. However, the Grocery Manufacturers Association (GMA) subsequently filed a lawsuit challenging that law. Colorado and Oregon meanwhile both have pending ballot initiatives that would require labels for foods containing GMOs.