New policy adopted by physicians at an American Medical Association (AMA) meeting calls for stricter federal regulation of dietary supplements, including modernization of the 1994 Dietary Supplement Health and Education Act (DSHEA).
WADA said it had urged Congress to modernize the DSHEA to allow the FDA to create a mandatory product registry to help detect harmful dietary supplements and remove them from the market. FDA, as well as several consumer and industry groups, support the requirement that manufacturers of dietary supplements list their products with the FDA.
The idea is to give the FDA and the public, including doctors and pharmacists, the ability to search all the labels of dietary supplement products in one centralized location, which increases transparency and allows the FDA to more easily identify products that may present risks to consumers.
In 2019, in commenting on the agency’s efforts to strengthen its regulation of supplementsthen FDA Commissioner Scott Gottlieb, MD, said the market contained between 50,000 and 80,000 dietary supplement products, possibly more. FDA officials have complained that they have little visibility of all products in the large market, complicating their efforts to enforce end-product brands or ingredient suppliers that may pose a risk to public health. .
“Patients and physicians alike expect the dietary supplements they buy and recommend to be safe, quality products, accurately labeled with their contents,” said the outgoing chairman of the board of directors of the AMA, Jesse M. Ehrenfeld, MD, in a Nov. 18 release. Press release. “As the dietary supplement industry continues to grow with little oversight, more and more people will use supplements without having a clear understanding of what these products contain, potentially putting their health at risk. We need the federal government to strengthen its regulation and enforcement of the dietary supplement industry to remove unsafe products from the market and protect public health. “
WADA has revealed that it wants to strengthen the authority and resources of the FDA to implement and enforce supplement policies, such as mandatory recall, risk-based inspections of manufacturing facilities, and strengthening adverse event notification systems.
The FDA already has mandatory recall power under law and conducts risk-based inspections of dietary supplement facilities. In FY20, of the 289 inspections conducted by the FDA for cGMP (Current Good Manufacturing Practices) compliance, the agency performed 74 “for cause” inspections of dietary supplement facilities to probe for issues. that have come to its attention, according to FDA records obtained by Natural. Product Insider via a Freedom of Information Act (FOIA) request.
Under the Dietary Supplement and Nonprescription Drug Consumer Protection Act, manufacturers and distributors of dietary supplements are also required to report “serious” adverse events associated with their products to the FDA, such as deaths, life-threatening experiences. in danger and hospitalizations. Some critics of the DSHEA favor a requirement that manufacturers report all adverse events to the FDA, not just “serious” ones.
WADA also supports certain requirements for product labels. Among them:
- Replace proprietary blends with a complete list of all ingredients;
- Added warnings about potential interactions between supplements and drugs; and
- Disclose precise and useful ingredient measurements.
WADA’s new policy also supports efforts to increase awareness among patients, healthcare professionals and retailers of resources to help patients select quality supplements, including educational efforts to develop knowledge labels, ”the medical group said. “WADA also urges physicians to ask their patients about their use of dietary supplements and to have risk-based conversations with them regarding the use of these products.”
FDA comments on DSHEA
Since the DSHEA was enacted in 1994, the dietary supplement market “has grown and changed in both size and scope,” according to FDA spokesperson Lindsay Haake.
“The basic DSHEA framework continues to provide valuable protections to consumers, but it is also worth considering whether we are fully realizing the DSHEA vision in light of a rapidly changing environment,” Haake said by e- mail. “Last year, the FDA announced a new policy advancement plan to implement one of the most significant modernizations in dietary supplement regulation and oversight in more than 25 years.”
The centerpiece of the plan, she added, is its proposal to change the law to require FDA registration of all products marketed as dietary supplements. The FDA made this proposal in President Donald Trump’s budget requests for fiscal years 2020 and 2021.
A mandatory list “would allow the agency to know when new products are introduced, to identify and act quickly against dangerous or illegal products, to improve transparency and to promote risk-based regulation,” said said Haake. “We are encouraged by the growing consensus from stakeholders across the spectrum in favor of these reforms and look forward to working with Congress and other stakeholders to advance this goal, as it would significantly improve the agency’s capacity. to effectively and efficiently protect public health. “
Response from trade groups to the supplement
“WADA’s call for tighter regulation and tighter FDA enforcement has many parallels with calls from the supplement industry – including members of the Consumer Healthcare Product Association (CHPA) – who believe that DSHEA needs to be modernized and strengthened, “said John Troup, PhD, vice president of scientific affairs and dietary supplements at CHPA, in a statement. declaration. “More than 25 years after the adoption of the DSHEA, the food supplements market has gone beyond the regulatory framework. Modernization is a significant public health issue, as bad actors continue to sell adulterated or mislabeled dietary supplements. “
Another industry trade group maintained that WADA’s policy minimized the health benefits of nutritional supplements and ignored the safety record of these products.
“Nutritional supplements are heavily regulated in the United States and their safety record is far superior to prescription and over-the-counter drugs, and even conventional foods,” said Dan Manufacturer, Ph.D., president and chief executive officer. the management of NPA, in a Press release.
America, he added, is suffering from “an opioid crisis”, which is unrelated to vitamin C.
“Of course, there is no substitute for healthy eating, exercise, and the right choices, and people should always speak to their doctor before deciding to take a supplement,” Manufacturer added. “But the truth is, few of us get enough nutrients from food alone, and nutritional supplements are essential for the millions of Americans who use them every day to support their health.”