The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the biggest change to the scope of the U.S. Food and Drug Administration's (FDA) regulatory authority over cosmetics since 1938. ...more
On December 26, 2023, the Food and Drug Administration (FDA) issued a Small Entity Compliance Guide Final Guidance Document: Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear,...more
The terms vegetarian and vegan are becoming more common. Initially, how to be a practicing vegetarian or vegan was the focus. Now, these terms are used to describe not only a lifestyle, but foods, cosmetics, and clothing. ...more
As we have previously discussed, a new law from New York State will require companies selling dietary supplements for weight loss or muscle building to pay close attention to consumers' age. This law went into effect on...more
Losing market share to a competitor touting its superiority makes your job harder and is frustrating, particularly when those claims are unsubstantiated or deceptive. You may want to counter your competitor’s claims with...more
As we have previously discussed, a new law from New York State will require companies selling dietary supplements for weight loss or muscle building to pay close attention to consumers' age. This law is to go into effect on...more
As promised last month, we are happy to announce that on April 3, FDA issued the New Dietary Ingredient Notification Master Files for Dietary Supplements draft guidance. In a related constituent update, FDA explained that the...more
On March 4, FDA announced the availability of a final guidance, Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes – Guidance for Industry. The guidance finalizes Section V: NDI Notification...more
Last month, New York quietly proposed a bill intended to protect children from advertising of unhealthy foods and the "disastrous health outcomes that follow the overconsumption of these products," suggesting that such...more
The Food and Drug Administration (FDA) regulates the marketing of dietary supplements, over-the-counter (OTC) drugs, cosmetics, medical devices, foods, infant formula, pet foods/supplements, and even e-cigarettes. However,...more
Last week, the U.S. Food and Drug Administration (FDA) launched Cosmetics Direct, a new electronic submission portal for the registration and listing of cosmetic product facilities and products under the Modernization of...more
This week, the Natural Products Association (NPA) filed a lawsuit against New York State challenging the constitutionality of a new state law prohibiting the sale of over-the-counter diet pills and dietary supplements for...more
On November 8, 2023, the United States Food and Drug Administration (FDA or agency) announced it does not intend to enforce the requirements related to cosmetic product facility registration and cosmetic product listing under...more
A new law from New York State will require companies selling certain dietary supplements in the state to pay close attention to consumers' age. Last week, Governor Kathy Hochul signed into law Assembly Bill A5610D, which...more
Thanks to the Food and Drug Omnibus Reform Act (FDORA), cosmetic companies will soon be subject to new requirements for registration, product listing, disclosure of ingredients, adverse event reporting, safety substantiation,...more
7/21/2023
/ Adverse Events ,
Best Practices ,
Cosmetics ,
Disclosure Requirements ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Filing Deadlines ,
Food and Drug Administration (FDA) ,
Interstate Commerce ,
Manufacturers ,
Manufacturing Facilities ,
New Legislation ,
Personal Care Products ,
Product Labels ,
Recordkeeping Requirements ,
Registration Requirement
The U.S. Supreme Court on Monday agreed to review Loper Bright Enterprises v. Raimondo, a direct challenge to Chevron deference. A decision in the case could either overrule Chevron altogether, or alternatively narrow the...more
On March 24, 2023, the Food and Drug Administration (FDA) finalized two transition plan guidance documents for medical devices that either 1) were issued Emergency Use Authorizations (EUAs), or 2) received enforcement...more
Infant formula manufacturers should be aware of several recent actions taken by the Food and Drug Administration (FDA).
In total, these actions reflect FDA's dedication of resources to the infant formula industry....more
On March 6, 2023 in a Constituent Update, the FDA announced the establishment of its new Dietary Supplement Ingredient Directory, created in an effort "to help manufacturers, retailers, and consumers of dietary supplements...more
Join us on December 14 for a webinar providing a 2022 FDA year-in-review, with a crystal ball look into 2023. Venable Partners Claudia Lewis and Todd Harrison will discuss myriad topics, including a recap of major issues...more
The U.S. Consumer Product Safety Commission (CPSC) is an independent federal agency that regulates the manufacture, distribution, and sale of consumer products in the United States. Specifically, the Commission is tasked with...more