Ms. Al-Mondhiry, regulatory counsel, CRN, was invited by NAAG to share the dietary supplement industry’s perspectives as part of a panel that included Pieter Cohen, M.D., assistant professor of Medicine, Harvard Medical School, and Maia Kats, director of Litigation, Center for Science in the Public Interest.
Ms. Al-Mondhiry observed that the biggest problem facing the dietary supplement industry comes from criminals who flout the laws and regulations governing dietary supplements and their ingredients and put consumers at risk, while also unfairly giving responsible industry a black eye. She noted that, “CRN is grateful for the opportunity to come together with other stakeholders at the NAAG meeting who want to put consumer safety first so we can arrive at a meaningful solution.”
During the panel presentation, Ms. Al-Mondhiry explained what the industry currently is doing to help ensure that products that reach consumers are safe and have truthful, accurate labeling. She explained the important role of FDA and federal regulation, including extensive good manufacturing practices (GMPs) that mandate 100% identity testing for raw materials and specifications for purity and strength, among other requirements. The federal legal framework for dietary supplements also provides FDA with various enforcement tools to take action against illegal ingredients and illegal claims, from seizures and mandatory recalls to civil and criminal penalties.
“Another key piece contributing to consumer safety is mandatory post-market surveillance—a law the dietary supplement industry helped to pass,” Ms. Al-Mondhiry said. The 2006 Dietary Supplement and Non-Prescription Drug Consumer Protection Act requires reporting of all serious adverse events to the FDA and recordkeeping of all adverse event reports a company receives about its products. These reports provide important information to regulators regarding potential safety issues in the supplement marketplace, allowing the agency to respond quickly to protect consumers.
Ms. Al-Mondhiry also focused on some of CRN’s educational and self-regulatory initiatives to help promote compliance within the industry. CRN and its members proactively developed science-based guidelines as part of its self-regulatory initiatives, including those on: iodine in multivitamin/mineral supplements for pregnancy and lactation; caffeine-containing dietary supplements; proper measuring and labeling of protein in dietary supplements and functional food; best practices for enzyme dietary supplement products; and safety considerations for dosage recommendations and labeling. In addition, CRN members adhere to a code of ethics. CRN also spearheaded the SIDI Work Group, which develops guidelines for ingredient vendor/supplier qualification. Additionally, the association has committed over two million dollars in grants for its advertising review program in partnership with the National Advertising Division to help rid the market of unsubstantiated claims.
Ms. Al-Mondhiry advised that despite these self-policing efforts, the industry doesn’t have an enforcement hammer to bring down on companies that actively ignore the laws. FDA, working with state agencies, can target the intentional wrongdoers who introduce illegal products and pass them off as dietary supplements. As the chief law enforcement officers in their states, state AGs can use their powers to target clear violations of the law such as illegal spiking of products. Said Ms. Al-Mondhiry, “CRN wants to continue working with FDA and also with the state AGs to help address this issue.”