By Michael McGuffin, President, American Herbal Products Association (AHPA)09.13.22
A recent Politico article reported that a long-running joke among U.S. Food and Drug Administration (FDA) officials is that “the ‘F’ in FDA is silent.” As FDA dedicates most of its budget and resources to drugs and medical devices, regulating food—including dietary supplements—appears to be less of a priority for the agency. This perceived disparity in regulation has led some to express concerns over the safety and reliability of our food supply.
Recently, FDA’s delayed responses to issues identified both during inspections and in whistleblower reporting likely contributed to the national infant formula shortage. Following criticism of the agency’s handling of the formula shortage, FDA Commissioner Robert Califf has asked the Reagan-Udall Foundation—an independent nonprofit created by Congress to advance the mission of FDA—to evaluate the agency’s food program.
Furthermore, recalls of conventional food products make up the majority of FDA recalls and are estimated to cost the country billions of dollars per year. In addition, millions of people in the U.S. are sickened by foodborne illness annually, despite the fact that most cases of foodborne illness are preventable. Altogether, confidence in FDA’s ability to keep Americans and our food supply safe has waned.
Though such amendments to FDA authority would be unprecedented and complex to carry out, proponents in Washington have recently thrust the idea into the spotlight for public discourse. Chief among them are U.S. Senator Dick Durbin (D-IL) and Congresswoman Rosa DeLauro (D-CT), who introduced the Food Safety Administration Act of 2022 (S.4520; H.R.8358) earlier this year in response to FDA’s “inadequate responses to recalls, a failure to implement a culture of outbreak prevention, and proposed rules and initiatives that languish for years.”
The idea of “splitting” FDA into two agencies is not new. In fact, Durbin and DeLauro have introduced similar legislation numerous times before, including, in the Senate, as far back as the 105th Congress with the Safe Food Act of 1997. Notably, bills introduced previously would have redefined “food” to exclude dietary supplements, but the Food Safety Administration Act would not, thanks in part to AHPA’s advocacy.
In meetings with congressional staff earlier this year, AHPA learned of an initial intention to have dietary supplements remain with drugs and be regulated by the renamed Federal Drug Administration, an approach that would not have had the support of AHPA or likely others in the industry. AHPA strongly communicated that any new law should not distinguish dietary supplements from other foods and that, thus, the new Food Safety Administration should have regulatory authority over both conventional foods and the food subcategory of dietary supplements.
Subsequently, upon its introduction in July, the Food Safety Administration Act did not contain language excluding dietary supplements from food. AHPA has formally endorsed this legislation, contingent upon dietary supplements’ remaining regulated as food and alongside conventional food by the new agency.
By its terms, the Food Safety Administration Act would be the most significant overhaul in federal regulation of food since the Food Safety Modernization Act (FSMA) of 2011. In keeping with its predecessors, however, the legislation is not expected to pass in the 117th Congress. Nevertheless, simply reassigning existing Federal Food, Drug, and Cosmetic Act (FFDCA) responsibilities to a new agency would not be enough to effectively modernize food regulation. In particular, dietary supplement regulations are in need of significant changes to meet the needs of today’s consumers and industry.
Another disservice to those who choose dietary supplements for their personal health is a holdover from the days before ecommerce; per the FFDCA, certain scientific publications must be kept “physically separate” from dietary supplements.
In practice today, that means that the website of a company selling dietary supplements cannot provide or link to scientific research or literature that merely mentions a “disease” use of an ingredient in the company’s products. Still, consumers can search for information on an ingredient on their own and be served results from sources that may not be reputable. Informed consumers should have access to truthful and not misleading information—especially in the form of scientific research—directly from the makers of the dietary supplements they buy.
Above all, FDA has a history of limiting access to dietary supplements, ranging from placing quantitative limits on nutrients to attempting to classify herbs as food additives. More recently, by invoking the drug exclusion provision of the FFDCA, FDA has confined cannabidiol (CBD) and N-acetyl cysteine (NAC) to a legal gray area despite consumer demand for these ingredients.
Instead of being kept out of the hands of those who want them, dietary supplements need what other categories regulated by FDA already have: an enforcement agency that is also an advocate for the products it regulates.
Though the Food Safety Administration Act is unlikely to pass, AHPA will continue to advocate for improving the safety and quality of—as well as access to—dietary supplements and natural products, including by remaining engaged in legislative activity in service to our industry and the public.
For the latest updates and guidance on matters affecting the regulatory landscape of the dietary supplement and natural products industries, don’t miss AHPA's Congress on Regulatory Priorities in the Natural Products Market, taking place virtually on November 15. Register now and save; early bird registration ends October 15.
About the Author: Michael McGuffin has served as president of the American Herbal Products Association since 1999, leading the association in its mission to promote the responsible and sustainable commerce of herbal products to ensure that consumers have informed access to a wide variety of safe herbal goods. McGuffin also serves on the boards of directors of the American Herbal Pharmacopoeia and United Plant Savers, and on the advisory boards of the USC School of Pharmacy regulatory science master’s degree program and the Appalachian Beginning Forest Farmers Coalition. An industry veteran, McGuffin has been active in the herbal community since 1974, and has taken the lead on legislative matters and regulatory advocacy that have shaped the herbal and natural products industry over the last several decades. For more information: www.ahpa.org.
Recently, FDA’s delayed responses to issues identified both during inspections and in whistleblower reporting likely contributed to the national infant formula shortage. Following criticism of the agency’s handling of the formula shortage, FDA Commissioner Robert Califf has asked the Reagan-Udall Foundation—an independent nonprofit created by Congress to advance the mission of FDA—to evaluate the agency’s food program.
Furthermore, recalls of conventional food products make up the majority of FDA recalls and are estimated to cost the country billions of dollars per year. In addition, millions of people in the U.S. are sickened by foodborne illness annually, despite the fact that most cases of foodborne illness are preventable. Altogether, confidence in FDA’s ability to keep Americans and our food supply safe has waned.
Calls for Reform
Critical of FDA’s inattention to food safety, dietary supplement industry leaders who have worked collaboratively with lawmakers on responsible regulation of the category—including the American Herbal Products Association (AHPA)—agree that improvements to federal oversight of food and dietary supplements are needed. This consensus raises the question: is it time to reassign the responsibility for the regulation and safety of the U.S. food supply?Though such amendments to FDA authority would be unprecedented and complex to carry out, proponents in Washington have recently thrust the idea into the spotlight for public discourse. Chief among them are U.S. Senator Dick Durbin (D-IL) and Congresswoman Rosa DeLauro (D-CT), who introduced the Food Safety Administration Act of 2022 (S.4520; H.R.8358) earlier this year in response to FDA’s “inadequate responses to recalls, a failure to implement a culture of outbreak prevention, and proposed rules and initiatives that languish for years.”
The Food Safety Administration Act
The proposed bicameral legislation would establish the Food Safety Administration under the Department of Health and Human Services (HHS). This new agency would assume all responsibilities for the regulation of food, including dietary supplements, currently held by FDA. In turn, FDA would be renamed the Federal Drug Administration and retain all responsibilities related to drugs, cosmetics, medical devices, biological products, color additives, radiation-emitting products, and tobacco products.The idea of “splitting” FDA into two agencies is not new. In fact, Durbin and DeLauro have introduced similar legislation numerous times before, including, in the Senate, as far back as the 105th Congress with the Safe Food Act of 1997. Notably, bills introduced previously would have redefined “food” to exclude dietary supplements, but the Food Safety Administration Act would not, thanks in part to AHPA’s advocacy.
In meetings with congressional staff earlier this year, AHPA learned of an initial intention to have dietary supplements remain with drugs and be regulated by the renamed Federal Drug Administration, an approach that would not have had the support of AHPA or likely others in the industry. AHPA strongly communicated that any new law should not distinguish dietary supplements from other foods and that, thus, the new Food Safety Administration should have regulatory authority over both conventional foods and the food subcategory of dietary supplements.
Subsequently, upon its introduction in July, the Food Safety Administration Act did not contain language excluding dietary supplements from food. AHPA has formally endorsed this legislation, contingent upon dietary supplements’ remaining regulated as food and alongside conventional food by the new agency.
By its terms, the Food Safety Administration Act would be the most significant overhaul in federal regulation of food since the Food Safety Modernization Act (FSMA) of 2011. In keeping with its predecessors, however, the legislation is not expected to pass in the 117th Congress. Nevertheless, simply reassigning existing Federal Food, Drug, and Cosmetic Act (FFDCA) responsibilities to a new agency would not be enough to effectively modernize food regulation. In particular, dietary supplement regulations are in need of significant changes to meet the needs of today’s consumers and industry.
Modernizing Dietary Supplement Regulations
The existing FDA has been criticized for lack of experience with food and dietary supplements, from the leadership level down to the staffers performing inspections. AHPA members have expressed frustration when FDA investigators who primarily inspect drug facilities and have little to no actual experience with food, botanicals, or dietary supplements conduct inspections of their facilities. A separate Food Safety Administration would provide the welcome opportunity for a food policy expert with actual experience in this class of goods to helm the agency responsible for regulating it.Another disservice to those who choose dietary supplements for their personal health is a holdover from the days before ecommerce; per the FFDCA, certain scientific publications must be kept “physically separate” from dietary supplements.
In practice today, that means that the website of a company selling dietary supplements cannot provide or link to scientific research or literature that merely mentions a “disease” use of an ingredient in the company’s products. Still, consumers can search for information on an ingredient on their own and be served results from sources that may not be reputable. Informed consumers should have access to truthful and not misleading information—especially in the form of scientific research—directly from the makers of the dietary supplements they buy.
Above all, FDA has a history of limiting access to dietary supplements, ranging from placing quantitative limits on nutrients to attempting to classify herbs as food additives. More recently, by invoking the drug exclusion provision of the FFDCA, FDA has confined cannabidiol (CBD) and N-acetyl cysteine (NAC) to a legal gray area despite consumer demand for these ingredients.
Instead of being kept out of the hands of those who want them, dietary supplements need what other categories regulated by FDA already have: an enforcement agency that is also an advocate for the products it regulates.
Advocating for Safety, Quality, and Access
Overall, AHPA supports the concept of establishing a food safety agency separate from FDA, especially given the need for category-specific expertise to more effectively guide food policy and regulation. However, reassigning oversight responsibilities would be just one step in the movement toward a modernized dietary supplement regulatory framework that best serves consumers.Though the Food Safety Administration Act is unlikely to pass, AHPA will continue to advocate for improving the safety and quality of—as well as access to—dietary supplements and natural products, including by remaining engaged in legislative activity in service to our industry and the public.
For the latest updates and guidance on matters affecting the regulatory landscape of the dietary supplement and natural products industries, don’t miss AHPA's Congress on Regulatory Priorities in the Natural Products Market, taking place virtually on November 15. Register now and save; early bird registration ends October 15.
About the Author: Michael McGuffin has served as president of the American Herbal Products Association since 1999, leading the association in its mission to promote the responsible and sustainable commerce of herbal products to ensure that consumers have informed access to a wide variety of safe herbal goods. McGuffin also serves on the boards of directors of the American Herbal Pharmacopoeia and United Plant Savers, and on the advisory boards of the USC School of Pharmacy regulatory science master’s degree program and the Appalachian Beginning Forest Farmers Coalition. An industry veteran, McGuffin has been active in the herbal community since 1974, and has taken the lead on legislative matters and regulatory advocacy that have shaped the herbal and natural products industry over the last several decades. For more information: www.ahpa.org.
