On December 1, the U.S. Food and Drug Administration (FDA) sent its proposed Generally Recognized as Safe (GRAS) rule, which is expected to mandate submission of GRAS notices for human and animal food substances, to the...more
12/8/2025
/ Administrative Procedure Act ,
Comment Period ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Food Safety ,
GRAS ,
Notice Requirements ,
OIRA ,
Proposed Rules ,
Rulemaking Process ,
Statutory Authority
On December 2, 2025, the FDA, with the Department of Justice and U.S. Marshals Service, seized approximately 73,000 units of 7-hydroxymitragynine (7-OH) products from three Missouri firms. ...more
On October 11, 2023, the United States Environmental Protection Agency (EPA) promulgated a final rule pursuant to section 8(a)(7) of the Toxic Substances Control Act (TSCA) imposing a one-time reporting obligation on entities...more
11/21/2025
/ Chemicals ,
Comment Period ,
Environmental Protection Agency (EPA) ,
Exemptions ,
Final Rules ,
Manufacturers ,
PFAS ,
Proposed Rules ,
Reporting Requirements ,
Rulemaking Process ,
Toxic Chemicals ,
Toxic Substances Control Act (TSCA)
The President signed into law the government funding package that includes a sweeping amendment redefining “hemp” and imposing a 0.4 mg total THC limit per finished product. ...more
11/17/2025
/ Agricultural Sector ,
Appropriations Bill ,
Cannabis Products ,
Compliance Dates ,
Controlled Substances ,
Department of Health and Human Services (HHS) ,
Federal Bans ,
Federal Funding ,
Food and Drug Administration (FDA) ,
Hemp ,
Hemp Related Businesses ,
New Legislation ,
New Regulations ,
THC
As of October of this year, seven states have passed EPR laws (i.e., California, Colorado, Maine, Maryland, Minnesota, Oregon, and Washington), and more have bills pending in their legislatures. These laws are intended to...more
Last month the Food and Drug Administration (FDA or the Agency) announced the launch of the FDA Adverse Event Reporting System (FAERS) Public Dashboard for Cosmetic Products. This interactive dashboard provides access to...more
On August 15, Illinois amended the Illinois Food, Drug and Cosmetic Act to impose certain labeling and testing requirements on baby food manufacturers. The law is similar to a California baby food law that became fully...more
9/15/2025
/ Amended Legislation ,
Baby Products ,
Consumer Protection Laws ,
Disclosure Requirements ,
Food Labeling ,
Food Manufacturers ,
Food Safety ,
Labeling ,
Product Labels ,
Regulatory Requirements ,
State and Local Government ,
Testing Requirements ,
Toxic Chemicals
Recent actions by the Food and Drug Administration (FDA or Agency) reflect a sharpened scrutiny in areas where public health and safety may be critical, but a more relaxed approach in areas where it views innovation may be...more
7/18/2025
/ Consumer Protection Laws ,
Cosmetics ,
Deregulation ,
Dietary Supplements ,
Enforcement Priorities ,
Final Rules ,
Food and Drug Administration (FDA) ,
Food Safety ,
Health and Safety ,
Imports ,
Manufacturers ,
Public Health ,
Regulatory Requirements
On January 15, 2025, the Food and Drug Administration (FDA or Agency) issued an order to revoke the authorization for the use of FD&C Red No. 3 (Red No. 3) in food and ingested drugs in response to a 2022 color additive...more
Last week, the U.S. Food and Drug Administration (FDA) issued two significant draft guidance documents concerning the use of artificial intelligence (AI) in medical devices and in drug and biological product development....more
1/16/2025
/ Artificial Intelligence ,
Bias ,
Biologics ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Medical Devices ,
Premarket Approval Applications ,
Product Development Protocols ,
Regulatory Requirements ,
Risk Management ,
Software ,
Transparency
On December 19, 2024, the Food and Drug Administration (FDA) announced a final rule updating the definition of the term "healthy" as used in food labeling. Under the rule, manufacturers may use the term "healthy" and similar...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
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
Earlier this month, the National Advertising Division of BBB National Programs (NAD) recommended that Amyris Clean Beauty, Inc.’s (Amyris) Biossance skincare products modify or discontinue several claims regarding their...more
The National Advertising Division of BBB National Programs (NAD) recommended last month that Stihl Incorporated USA (Stihl), a manufacturer of equipment and tools, discontinue or modify its unqualified “Made in America”...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
The latest efforts by the U.S. Food and Drug Administration (FDA) to modernize regulation of the 510(k) program come in the form of a trio of new draft guidance documents regarding its Premarket Notification program for...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
Since its enactment in 2017, Public Law No. 115-92 has significantly boosted the availability of medical products that protect and treat military personnel. Designed to overcome the unique challenges posed by military medical...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
Last week the Federal Trade Commission (FTC) announced it had issued a complaint and proposed consent order against Instant Brands LLC for allegedly marketing products as “Made in the USA,” when they were actually made in...more
On December 20th, 2022, the Federal Trade Commission published new guidance regarding claims about the benefits and safety of health-related products: Health Products Compliance Guidance. This guidance replaces the...more
At its December 14, 2022 open meeting, the Federal Trade Commission announced it would publish a notice in the Federal Register seeking comment on potential updates or revisions to its existing Green Guides. The Green Guides...more