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Full-Text Articles in Entire DC Network
I’M Not Lovin’ It: Re-Thinking Fast Food Advertising, Brody Shea, Michael S. Sinha
I’M Not Lovin’ It: Re-Thinking Fast Food Advertising, Brody Shea, Michael S. Sinha
Journal of Food Law & Policy
In 1971, the Federal Trade Commission (“FTC”) and the Food and Drug Administration (“FDA”) agreed to prevent injury and deception to the consumer in advertising, detailing their respective roles in a Memorandum of Understanding (“MOU”). The MOU has been amended and an addendum added since 1971, but the material provisions have remained consistent for over a half-century. The FTC has regulatory authority over fast food advertising while the FDA regulates fast food, which creates a proverbial fork in the road. The fork in the road widens when considering the FDA has an active role in curbing the obesity epidemic through …
Criminalizing Transgender Care, Lewis Grossman
Criminalizing Transgender Care, Lewis Grossman
Articles in Law Reviews & Other Academic Journals
Since 2021, twenty-four states, in extraordinarily quick succession, have enacted statutes banning physicians from prescribing puberty blockers and cross-sex hormones to minors for treatment of gender dysphoria. Although the Food and Drug Administration has not approved these drugs for this use, off-label prescribing is a common practice, and leading medical organizations all agree that this off-label use of puberty blockers and sex hormones is an essential component of transgender medical care. These state laws thus represent an extreme, and unprecedented, interference with the provision of standard-of-care medicine. This article, after exploring the ongoing litigation challenging these bans, argues that they …
Exasperated But Not Exhausted: Unlocking The Trap Set By The Exhaustion Doctrine On The Fda’S Rems Petitioners, Michael Krupka
Exasperated But Not Exhausted: Unlocking The Trap Set By The Exhaustion Doctrine On The Fda’S Rems Petitioners, Michael Krupka
Vanderbilt Law Review
When health is at stake, bureaucratic delays can be disastrous. This is especially true in the field of pharmaceutical regulation. Fortunately, concerned parties—ranging from research institutions and universities to doctors and pharmaceutical companies—can file citizen petitions to urge the Food and Drug Administration (“FDA”) to regulate potentially risky drugs through Risk Evaluation and Mitigation Strategies (“REMS”) programs. But despite submitting comprehensive citizen petitions calling for changes to REMS determinations, petitioners regularly await the FDA’s response for years. When these petitioners, still awaiting an FDA determination, have sought recourse in the courts, the agency has argued that these petitioners have not …
Re-Regulating Dietary Supplements, Jessie L. Bekker, Alex Flores, Michael S. Sinha
Re-Regulating Dietary Supplements, Jessie L. Bekker, Alex Flores, Michael S. Sinha
Journal of Food Law & Policy
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 …