The National Association of Attorneys General met in St. Louis yesterday with one of its three agenda items being what to do about herbal supplements. The issue had been given life by a February sting operation by the attorney general of New York state, using DNA barcoding technology, in an attempt to demonstrate adulteration problems in the botanicals field.
Approximately 80 assistant state attorneys general were in attendance to help support efforts to rid the marketplace of the most serious issue facing the supplement industry and its consumers.
The supplement industry's representative on the guest panel, Rend Al-Mondhiry, regulatory counsel at the Council for Responsible Nutrition, used her time to open eyes to the greater issue—prosecuting companies that spike products with illegal drugs and market them as supplements.
"These types of activities clearly violate the law and present real risks to public health," said Al-Mondhiry. "This is where state AGs can be most effective in protecting consumers and can coordinate with FDA to target these illegal products."
She said 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 National Association of Attorneys General meeting who want to put consumer safety first so we can arrive at a meaningful solution.”
The poster children of undeclared ingredients—aka, adulterants—include sibutramine (Meridia), a weight-loss pharmaceutical found in scurrilous supplements, or sildenafil (Viagra), an erectile dysfunction drug found in sexual performance supplements. These two health categories, as well as certain sports supplements, are the primary categories that experiencing such adulteration in the supplements world.
"It's not something that's going to go away," said Jim Lassiter, founder/COO of Ingredient Identity, a consultancy that helps supplement companies navigate product development processes. "It's current and will remain current for the foreseeable future."
During the panel presentation, 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 percent 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,” 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.
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.
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, she said.
The industry has also been working on elevating its profile within the FDA in the hopes of making enforcement actions more efficient. Action is expected within the next year.