Tag:

FDA

The FDCA and Cosmetics Enforcement: Better Late than Never

In March 2019, the FDA issued a statement explaining that asbestos was found in certain cosmetic products sold at retail stores Claire’s and Justice. The Food, Drug, and Cosmetics Act (FDCA) has always granted the FDA similar authority to monitor cosmetic products for adulteration or misbranding as it does food. However, litigation in this area was notably silent. The FDA’s change in position on its authority is long overdue.

How Will Recreational Marijuana Impact Illinois? 

During Governor-elect J.B. Pritzker’s election campaign, he heavily advocated for Illinois to be more accommodating to recreational marijuana usage. In Illinois, medical marijuana has already been legalized, and new bills are being introduced to make it more accessible. If recreational marijuana is legalized, Illinois will join ten states, and the District of Colombia, in its authorization.

The Ugly Side of Beauty: How Under-Regulation of Cosmetics Harmed Consumers for Decades   

It is no secret that the beauty industry in America is frighteningly under-regulated. Cosmetics companies and beauty brands have managed to escape meaningful regulatory oversight for roughly a century and are largely left to self-regulate. In 2017, the global cosmetic products market was valued at $532 billion and is expected to reach a market value of $806 billion by 2023, registering a compound annual growth rate of 7.14%. Despite the colossal financial growth, regulatory shortcomings leave much to be desired by consumers. On the back of numerous harmful side-effects scandals and multi-million dollar class-action settlements, the FDA must grapple with renewed demand for cosmetics regulation as new beauty trends emerge.

Sunscreen Regulations: Providing Protection for Consumers and Difficulties for Manufacturers

In 2014, Congress passed the Sunscreen Innovation Act in the hopes of encouraging innovation for new sunscreen ingredients. Recently, the United States Food and Drug Administration (FDA) proposed new regulations regarding over-the-counter sunscreens to keep up with recent scientific and safety information. This proposal will be available for ninety days from its announcement on February 21, 2019, and addresses safety concerns of common sunscreen ingredients. Further, the proposal addresses the labeling of sunscreen, trying to make it easier for consumers to identify the product information. While this proposal seeks to alleviate safety concerns, the regulation could potentially make it more difficult for new ingredients to be approved.

Senators Urge FDA to Update Its Regulation on Products Containing Hemp and Hemp-derived Compounds

On January 15, 2019, Senators Ron Wyden and Jeff Merkley sent a letter to the U.S. Food and Drug Administration (FDA) urging the agency to update its federal regulations governing the use of certain cannabis-derived ingredients in food, beverages and dietary supplements. As writers of the Hemp Farming Act, Wyden and Merkley, initiated the removal of the hemp plant and derivatives of Cannabis sativa from the list of controlled substances under the Controlled Substance Act. The Hemp Farming Act passed as a provision in the Agriculture Improvement Act of 2018, and thus, legalized the production and sale of industrial hemp and hemp-derived compounds, including cannabidiol (CBD).

Pressing Pause: A Survey of Regulatory Recovery After the Government Shutdown

Although the nation’s longest-ever government shutdown has ended, agencies forced to furlough employees and shutter temporarily are still facing the effects of the funding gap. On January 25th, President Trump agreed to sign a continuing resolution that will reopen and fund the federal government through February 15th. The government reboot means that the roughly 800,000 federal employees furloughed or forced to work without pay should expect to receive their back pay soon, but the thirty-five-day suspension of government functions comes with significant aftershock. While various regulatory agencies scramble to address their backlog of work, life for Americans who interact with these agencies has been hindered indefinitely.

The Years Long Process to a Revised Common Rule and Implementation

The Common Rule, the Federal policy protecting human subjects of biomedical and behavioral research, was published in 1991. The process to update the policy has taken place over the last several years, leading to the final rule revisions which were effective as of July 19, 2018. After January 20, 2019, institutions are now permitted to implement the entirety of the revised Common Rule. Any institution receiving funds, supervision, or review from any of the twenty Federal Departments and Agencies that have codified the Common Rule must implement this revised rule in their compliance programs.

We Need to Change the Way We Deal with Food Recalls

In September 2018, the Food and Drug Administration (“FDA”) announced a new policy that provides for the release of a list of retailers that have received a food subject to recall. In the past, the FDA did not release such information because the agency deemed it confidential commercial information. The lack of information on the part of the FDA has been a huge detriment to the public. Prior to the new guidance, the public would only find out information about the particular food that was being recalled, not where this recalled food was available for purchase. The public was told just to stop purchasing that recalled food, whether it be romaine lettuce or beef, even if there were retailers who were selling non-contaminated products. This procedure not only hurts the public but also has a huge financial effect on those retailers who are not selling contaminated or recalled products. The FDA has effectuated a new guidance because they have found that such information is necessary to enforce a recall and to ensure public safety.

Joint Agency Decision Serves Up A New Regulatory Framework For Cell-Based Meat

Following a public meeting in October, the Food and Drug Administration (FDA) and the United States Department of Agriculture (USDA) agreed to share joint regulation of cell-culture “meat” technology. This decision came on the tail end of public squabble between the two regulatory bodies regarding the oversight of cell-culture, or lab-produced meat.  The regulatory framework for this type of quasi-agriculture has been unclear, especially after the White House Office of Science and Technology Policy issued the Coordinated Framework for the Regulation of Biotechnology initiative that attempted to coordinate the roles of various agencies involved in emerging biotechnology. The new, definitive regulatory structure has been thoroughly praised and welcomed by top cell-culture meat companies, who have expressed open frustration with the older, confusing framework, claiming that it hindered both consumer protection and technological innovation.

FDA Warns E-Cigarette Manufacturers: Stop Teen Epidemic or Face Consequences

The rise of electronic cigarettes was initially met with relaxed FDA regulation given optimism that they could help adult smokers curb use of more toxic combustible cigarettes. This optimism was in spite of e-cigarettes’ growing popularity among adolescents and young adults. On September 12, the FDA signaled a pivot from this approach when FDA Commissioner Scott Gottlieb described youth e-cigarette use as having reached epidemic proportions. Gottlieb announced that the FDA had issued more than 1,300 warning letters and fines to retailers caught selling e-cigarette products to minors. It also issued an order to the five major e-cigarette manufacturers (Juul, Vuse, Blu, MarkTen XL, and Logic) to each submit a plan outlining how the company will address youth access and use of their products. Failure to submit a sufficient plan could lead the FDA to revisit its earlier decision on flavored e-cigarette products, which allowed manufacturers a grace period until 2022 to receive FDA approval.