Food and drug law journal最新文献

Scientists have repurposed an adaptive immune system of single cell organisms to create a new type of gene-editing tool: CRISPR (clustered regularly interspaced short palindromic repeats)-Cas technology. Scientists in China have reported its use in the genome modification of non-viable human embryos. This has ignited a spirited debate about the moral, ethical, scientific, and social implications of human germline genome engineering. There have also been calls for regulations; however, FDA has yet to formally announce its oversight of clinical applications of CRISPR-Cas systems. This paper reviews FDA regulation of previously controversial biotechnology breakthroughs, recombinant DNA and human cloning. It then shows that FDA is well positioned to regulate CRISPR-Cas clinical applications, due to its legislative mandates, its existing regulatory frameworks for gene therapies and assisted reproductive technologies, and other considerations.

Evolving First Amendment principles are forcing FDA and other federal regulators of medical products to rethink traditional regulatory approaches to off-label product communications. State regulators, which have actively sought injunctions restricting manufacturer communications to the four-corners of the FDA-approved product label, must additionally abide by federal preemption principles. This article reviews the application of preemption principles to off-label communications and concludes that most, if not all, state-law restraints on off-label communications are preempted by federal law. This finding has important implications for state enforcement initiatives, and puts into question the validity of some elements of existing state-law injunctions.

On May 27, 2016, the Food and Drug Administration (FDA) announced that it was adopting a new rule that requires food manufacturers to list—on the already mandated Nutrition Facts label—how many grams of sugar have been added to a food product. Many opponents have criticized this “added sugars” rule on First Amendment grounds, arguing that the rule violates the commercial speech rights of food manufacturers. Whether the rule would survive constitutional scrutiny or not is an open question because the compelled commercial speech doctrine is anything but clear. Courts are split over whether Zauderer’s rational basis test, Central Hudson’s intermediate scrutiny, or some combination of the two should apply to a mandated disclosure like FDA’s added sugars rule. This Paper explains that the added sugars rule is unique in the history of mandated nutrition labeling in that the rule is motivated largely by public health concerns and backed by reports that assert that consumers should limit their intake of added sugars. In contrast, correcting and preventing consumer deception has been a major driving force behind the remainder of FDA’s mandated nutrition labeling. Because of this distinct rationale, the added sugars rule does not fit neatly into any currently existing compelled commercial speech test. This Paper uses the added sugars rule to highlight the deficiencies in the existing tests. Finally, this Paper proposes a new compelled commercial speech test that would adequately balance the interest of all of the effected parties: the government, the public, and food manufacturers.

Harm reduction is an internationally recognized tobacco control strategy. E-cigarettes, being a less harmful alternative to smoking, have the potential to achieve harm reduction. Within this context, this article critiques Hong Kong’s legal regime governing e-cigarettes and the proposed prohibition of the product. It is argued that the current law is uncertain and inadequate. Although a reform of laws relating to e-cigarettes is needed, it is argued that banning the product altogether as a means to reducing the harm of tobacco use is unsupported by evidence.