By Nicholas Traver.
The U.S. Food and Drug Administration (FDA) is once again demanding stronger safety regulations and increased funding for its regulation of the dietary supplement industry. This month, the FDA released its budget request for fiscal year 2023 totaling $8.3 billion. The budget proposal exceeds FY2022’s request by almost $2 billion and includes specific funding requests and amendments that would permit the FDA to increase regulations of dietary supplements by requiring supplement manufacturers to register their products with the FDA. This registration requirement would help the FDA.
Consumer Harms from Dietary Supplements
The FDA’s cause for concern over dietary supplements is noteworthy. For years, the FDA has seen questionable manufacturers bypass legal requirements and introduce deleterious products into the market. Recently in California, a man named Nam Hyun Lee was sentenced to 46 months in prison for selling thousands of adulterated supplements advertised as herbal sexual enhancement products. Lee raked in millions from the contaminated pills, which contained undisclosed and illegal prescription drugs like Cialis imported from overseas. The inclusion of undisclosed pharmaceuticals in sexual enhancement supplements has resulted in claims of death and neurological damage. Non-compliant and harmful products have been discovered across the entire industry, from prenatal vitamins contaminated with metal mesh material, incorrectly labeled herbal ingredients, and even sports nutrition supplements laced with steroid-like compounds. While many consumers are not destined for such fates, the frequency with which contamination events like these occur is alarming.
These harms are increasing. Dietary supplements’ popularity has skyrocketed nearly tenfold over the past three decades. This growth is due in part to the development of “wellness culture,” where consumers show preference for integrating holistic and preventative approaches to their health. Many consumers are also persuaded by the aggressive marketing claims dietary supplement companies can make. This growth has turned what was once a $4 billion market with a measly estimated 4,000 products in 1994 into what is now a $40 billion industry with up to 80% of Americans taking at least one of the over 80,000 products available daily. The entire global dietary supplement market is projected to reach $306 billion by 2026.
A Flawed System
Dietary supplements can often successfully reach the market without even notifying the FDA of their existence. The market expansion has also outpaced the funding and resources of the FDA, effectively precluding them from thoroughly vetting every manufacturer. The FDA’s authority to regulate dietary supplements is largely guided by the provisions of the Dietary Supplement Health & Education Act (DSHEA). Passed in 1994, the DSHEA amended the Food, Drug, and Cosmetic Act of 1934 and permits the FDA to act on products that are “adulterated” or “misbranded.” The FDA does not have the authority to require dietary supplement companies to make demonstrations of safety or efficacy like those required for drugs.
The passage of the DSHEA was the result of a century-long battle between the FDA and the dietary supplement industry where the FDA wanted to control supplements similarly to drugs. Prior to 1994, the FDA had stronger authority over dietary supplements and routinely attempted to strong-arm dietary supplements towards a pre-market approval model to protect consumers. This approach was not popular, and consumers mistakenly believed the FDA was on a mission to take dietary supplements away for good. Spearheaded in part by Senator Orin Hatch of Utah, the passage of the DSHEA followed one of the largest public protests in history; thousands of letters were sent to Congress in support of “health freedom.” Since its passage, the DSHEA has hampered the FDA’s attempts to regulate quality within the market.
The FDA’s 2023 Budget Proposal
The 2023 proposal seeks to amend the DSHEA in two ways. First, it would require manufacturers to annually list their individual dietary supplement products with the FDA. The FDA argues this would allow them to know when new products reach the market and take quicker action on any that are noncompliant. Such a requirement would also increase compliance with current reporting requirements. Manufacturer non-compliance has been a major burden on the FDA. Nearly 70% of manufacturers fail to meet the current legal requirements of the DSHEA. Currently, the FDA requires manufacturers themselves to register with the agency, but there is notorious non-compliance with this requirement. However, if unregistered products are considered “misbranded” under the DSHESA, stores could not knowingly sell such products. Thus, manufacturers would have to register and report information to make any profits.
Second, the proposal seeks clarification on the FDA’s authority over dietary supplements “to better facilitate enforcement against unlawfully marketed products, allowing the FDA to know when new products are introduced, quickly identify dangerous or illegal products on the market and take appropriate action to protect consumers.” Such clarification would likely be necessary to enable the FDA to create a registration requirement, and to determine what actions it could perform as a result. Clarification would also be useful to resolve ambiguities in the application of the current law, which has been an ongoing battle. Finally, the overall funding increase requested by the FDA would go towards the development and enforcement of this new registration requirement. To house the product data, the FDA would need to develop new IT infrastructure and hire more full-time employees to review the data.
The Industry Responds
The Proposal has already received mixed reviews. Some have applauded the FDA’s attempt to further consumer protection, while others have questioned the effectiveness of the registration requirement. Some go so far as to equate it to premarket approval, like the disfavored approach the FDA used prior to the DSHEA. In Arizona, the proposed product registration requirement may offer consumers stronger assurances that their dietary supplement products are being properly overseen and their health is being protected. Until such assurances are provided, Arizonians should remain vigilant that their dietary supplements are of good quality and from reputable sources.