Re-Regulating Dietary Supplements

In 1994, Congress introduced the Dietary Supplement Health and Education Act (DSHEA) to create a regulatory framework for the dietary supplement industry. Despite the increased market size of dietary supplements, the Food and Drug Administration’s (FDA) pre-market authority to regulate the introduction of dietary supplements into the stream of commerce has remained subdued. Under DSHEA, the FDA has limited authority to review dietary supplements before entering the market. Unlike pharmaceuticals, which must be proven safe and effective prior to approval and marketing, dietary supplements can be sold to consumers without such reassurances. We call on Congress to amend DSHEA to grant the FDA the additional express statutory authority to fix these problems

Re-Regulating Dietary Supplements

In 1994, Congress introduced the Dietary Supplement Health and Education Act (DSHEA) to create a regulatory framework for the dietary supplement industry. Since the passage of DSHEA nearly thirty years ago, U.S. adults have steadily increased their annual consumption of dietary supplements. The once $4 billion industry comprising approximately 4,000 products has swelled to a$40 billion trade with anywhere from 50,000 to 80,000 dietary supplements available over-the-counter. Despite the increased market size of dietary supplements, the Food and Drug Administration’s (FDA) pre-market authority to regulate the introduction of dietary supplements into the stream of commerce has remained subdued. Under DSHEA, the FDA has limited authority to review dietary supplements before entering the market. Unlike pharmaceuticals, which must be shown to be safe and effective prior to approval and marketing, dietary supplements can be sold to consumers without such reassurances. Instead, the FDA’s authority is generally limited to post-market enforcement under DSHEA. In fact, the FDA lacks the express authority to remove dietary supplements from the market unless it can establish that the products are unsafe, adulterated, mislabeled or misbranded. Given the morbidity and mortality associated with adulterated dietary supplements and the challenges in addressing the latest fads before they cause harm, Congress must give the FDA the power it needs to be proactive. The FDA desperately needs the tools to regulate the dietary supplement industry and remove harmful dietary supplements from the market. We call on Congress to amend DSHEA to grant the FDA the express statutory authority to (1) regulate dietary supplements prior to entering the market; (2) require manufacturers to submit Supplement Labels to the FDA for pre-market review; (3) require that supplements undergo both pre-market composition testing and post-market randomized composition testing; (4) strengthen agency authority to remove adulterated dietary supplements from the market; and (5) establish an excise tax on dietary supplements

Re-Regulating Dietary Supplements

In 1994, Congress introduced the Dietary Supplement Health and Education Act (DSHEA) to create a regulatory framework for the dietary supplement industry. Despite the increased market size of dietary supplements, the Food and Drug Administration’s (FDA) pre-market authority to regulate the introduction of dietary supplements into the stream of commerce has remained subdued. Under DSHEA, the FDA has limited authority to review dietary supplements before entering the market. Unlike pharmaceuticals, which must be proven safe and effective prior to approval and marketing, dietary supplements can be sold to consumers without such reassurances. We call on Congress to amend DSHEA to grant the FDA the additional express statutory authority to fix these problems

Finding the Cluster: Balancing Privacy and Public Health Amid the Covid-19 Pandemic

More than 800,000 Americans have died and more than fifty-seven million sickened since March 2020 from the COVID-19 virus and its highly contagious variants. Public health officials urged the public to mask up, socially distance, and stay home in order to curb the virus’ spread in the early months of the pandemic before a vaccine was approved. Meanwhile, those same officials blocked access to valuable information pinpointing areas of disease concentration—“hotspots”—which could have alerted members of the public of locations to avoid. Those officials generally—and usually incorrectly—cited the Health Insurance Portability and Accountability Act (HIPAA) as grounds for information blocking, likely to bypass liability if information released was not properly de-identified under the law. While the secrecy may have caused confusion and distrust among the general public, there is insufficient guidance for health officials to determine which health-related data can and cannot be shared. The Office for Civil Rights, housed under the federal Department of Health and Human Services, sanctions HIPAA offenses, and thus can play a uniquely influential role in access to public health information by issuing guidance for health officials that explains HIPAA’s privacy rules and their limitations

Finding the Cluster: Balancing Privacy and Public Health Amid the Covid-19 Pandemic

More than 800,000 Americans have died and more than fifty-seven million sickened since March 2020 from the COVID-19 virus and its highly contagious variants. Public health officials urged the public to mask up, socially distance, and stay home in order to curb the virus’ spread in the early months of the pandemic before a vaccine was approved. Meanwhile, those same officials blocked access to valuable information pinpointing areas of disease concentration—“hotspots”—which could have alerted members of the public of locations to avoid. Those officials generally—and usually incorrectly—cited the Health Insurance Portability and Accountability Act (HIPAA) as grounds for information blocking, likely to bypass liability if information released was not properly de-identified under the law. While the secrecy may have caused confusion and distrust among the general public, there is insufficient guidance for health officials to determine which health-related data can and cannot be shared. The Office for Civil Rights, housed under the federal Department of Health and Human Services, sanctions HIPAA offenses, and thus can play a uniquely influential role in access to public health information by issuing guidance for health officials that explains HIPAA’s privacy rules and their limitations

Re-Regulating Dietary Supplements

In 1994, Congress introduced the Dietary Supplement Health and Education Act (DSHEA) to create a regulatory framework for the dietary supplement industry. Since the passage of DSHEA nearly thirty years ago, U.S. adults have steadily increased their annual consumption of dietary supplements. The once $4 billion industry comprising approximately 4,000 products has swelled to a$40 billion trade with anywhere from 50,000 to 80,000 dietary supplements available over-the-counter. Despite the increased market size of dietary supplements, the Food and Drug Administration’s (FDA) pre-market authority to regulate the introduction of dietary supplements into the stream of commerce has remained subdued. Under DSHEA, the FDA has limited authority to review dietary supplements before entering the market. Unlike pharmaceuticals, which must be shown to be safe and effective prior to approval and marketing, dietary supplements can be sold to consumers without such reassurances. Instead, the FDA’s authority is generally limited to post-market enforcement under DSHEA. In fact, the FDA lacks the express authority to remove dietary supplements from the market unless it can establish that the products are unsafe, adulterated, mislabeled or misbranded. Given the morbidity and mortality associated with adulterated dietary supplements and the challenges in addressing the latest fads before they cause harm, Congress must give the FDA the power it needs to be proactive. The FDA desperately needs the tools to regulate the dietary supplement industry and remove harmful dietary supplements from the market. We call on Congress to amend DSHEA to grant the FDA the express statutory authority to (1) regulate dietary supplements prior to entering the market; (2) require manufacturers to submit Supplement Labels to the FDA for pre-market review; (3) require that supplements undergo both pre-market composition testing and post-market randomized composition testing; (4) strengthen agency authority to remove adulterated dietary supplements from the market; and (5) establish an excise tax on dietary supplements