August 9, 2022

Volume XII, Number 221

Advertisement
Advertisement

August 08, 2022

Subscribe to Latest Legal News and Analysis

Senate Committee Passes the FDA Safety and Landmark Advancements Act

  • On June 14, 2022, the Senate Health, Education, Labor, and Pensions (HELP) Committee passed the FDA Safety and Landmark Advancements (FDASLA) Act (S. 4348) which proposes various changes to the regulation of dietary supplements and cosmetics. The legislation was originally introduced by Sen. Patty Murray (D-WA) on May 26, 2022 and would amend Chapter IV of the Federal Food, Drug, and Cosmetic Act.

  • Specifically, in regard to dietary supplements, the Act would require that companies list their products with the FDA.  The information required to be submitted in connection with the listing includes the name of the supplement; the name and address of the manufacturer, packer, or distributor appearing on the label, and contact information for the owner or operator; the business name and mailing address of all locations in which the dietary supplement is manufactured, packaged, labeled, or held; a list of all ingredients in each supplement; the number of servings per container; directions for use; warnings, notice, and safe handling statements; allergen statements; any health or structure/function claims; and the dietary supplement product listing number. Subject to limited exceptions, this information would be made publicly available in a searchable electronic database.

  • The Act also proposes changes to the regulation of cosmetics. These include (1) adverse event reporting requirements; (2) the establishment of good manufacturing practices (GMPs) for cosmetics facilities; (3) registration and product listing requirements; (4) requirements to maintain records supporting the safety of the cosmetic product; (5) a labeling requirement to include contact information for adverse event reporting; (6) requirement to have records accessible to FDA if there is a reasonable belief that the product (or ingredients therein) presents a threat of serious adverse health consequences; and (7) a mandatory recall authority. In establishing GMP regulations, FDA is directed to consider the size and scope of the cosmetics manufacturer, the risks to public health, and to provide flexibility for different types of facilities. Currently, there is a GMP checklist for cosmetics manufacturers to follow for inspections, but no regulations have been promulgated.

  • Mandatory listing requirements for dietary supplement companies and strengthening of dietary supplement regulation have previously been considered by the FDA. Keller and Heckman will continue to monitor this legislation and report on any further updates.

  • Nicholas Prust, Natalie Rainer, and Frederick Stearns also contributed to this article. 

© 2022 Keller and Heckman LLPNational Law Review, Volume XII, Number 179
Advertisement
Advertisement
Advertisement
Advertisement
Advertisement
Advertisement

About this Author

Lisa P. Alsobrook Attorney Keller Heckman DC Office
Associate

Lisa Alsobrook practices in the area of food and drug law. She advises domestic and foreign clients on regulatory requirements for foods, dietary supplements, cosmetics, and food and drug packaging in jurisdictions around the world. Her main focus is regulatory and compliance matters of the U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture relating to human food, food packaging material, animal feed, food additives and ingredients, and dietary supplements.

Prior to attending law school, Lisa earned a master’s degree in Food Science. She worked as a...

202-434-4237
Melvin S. Drozen, FDA, regulatory lawyer, Keller Heckman, law firm
Partner

Melvin S. Drozen joined Keller and Heckman in 1987.

Mr. Drozen advises clients on a broad spectrum of FDA, FTC, USDA and EPA (pesticides) regulatory matters, ranging from premarket approval requirements for food additives, dietary supplement ingredients, drugs, and medical devices to advertising and labeling provisions applicable to all of these products. Prior to joining Keller and Heckman, he was an Assistant District Attorney in Brooklyn, N.Y., and then an attorney in the General Counsel's Office of the Food and Drug Administration for seven...

202-434-4222
Jill M Mahoney Associate Attorney Keller Heckman
Associate

Jill Mahoney advises clients on regulatory requirements for food, animal feed, food additives, dietary supplements, and cosmetics. She counsels clients on labeling and advertising compliance and claims substantiation issues, including nutrition labeling, ingredient declarations, nutrient content claims, structure function claims, and Country of Origin labeling. She assists food, animal feed, and dietary supplement manufacturers in preparing self-determined GRAS positions, GRAS Notifications for Food and Drug Administration (FDA) submissions, New Dietary Ingredient Notification submissions...

202-434-4184
Richard Mann Partner Keller Heckman DC
Partner

Richard (Rick) Mann represents his clients in business and trade association disputes relating to food advertising, promotional and labeling claims, food safety and compliance issues, and general business and corporate law matters.

Rick works extensively with clients in the development of compliant advertising, promotional, and labeling claims and campaigns, and the development of appropriate support for such claims. His regulatory experience allows him to represent his clients in proceedings at the Food and Drug Administration (FDA), the Federal Trade Commission (FTC), the National...

202-434-4229
Paula S. Pastuskovas San Francisco Food and Drug Attorney Keller and Heckman
Associate

Paula Pastuskovas counsels domestic and international clients on regulatory and compliance matters in food and drug law. She assists clients in obtaining regulatory clearances for food additives and food-contact materials from the U.S. Food and Drug Administration (FDA), Health Canada, and other comparable international agencies. She advises clients on food labeling, ingredient, and substantiation issues. 

As a resident of the firm’s San Francisco office, Paula also advises companies on compliance with California’s state and local laws. This...

415-948-2830
Advertisement
Advertisement
Advertisement