News & Analysis as of

Regulatory Requirements › Public Health › Federal Food Drug and Cosmetic Act (FFDCA)

Troutman Pepper Locke

Are State ENDS Directories Preempted? Federal Courts Are Split

Troutman Pepper Locke on

Over the past two years, at least 15 states have enacted laws requiring manufacturers of electronic nicotine delivery systems (ENDS) to certify the status of their federal premarket tobacco product applications (PMTAs) in...more

Kelley Drye & Warren LLP

MAHA Movement Continues to Invite Significant Change for Food Regulation at Federal and State Levels

Kelley Drye & Warren LLP on

Robert F. Kennedy Jr. promised big changes as Secretary of the Department of Health & Human Services, the sweeping agency that oversees FDA, NIH, CDC, and other divisions and agencies. Five months into his tenure, he has...more

Husch Blackwell LLP

Eliminating the GRAS “Loophole”: Implications for Functional Foods and Beverages

Husch Blackwell LLP on

On March 10, 2025, the U.S. Department of Health and Human Services (HHS) announced that U.S. Secretary of HHS Robert F. Kennedy Jr. directed the U.S. Food and Drug Administration (FDA) to explore closing the GRAS...more

Epstein Becker & Green

The End of the Self-Affirmed GRAS Pathway?

Epstein Becker & Green on

On March 10, 2025, Robert F. Kennedy, Jr., Secretary of the U.S. Department of Health and Human Services (“HHS”), in a seismic shift, announced that the U.S. Food and Drug Administration (“FDA”) would “explore potential...more

Morgan Lewis - Well Done

The Future of Artificial Colors in the US Food Supply Is Not So Bright

Morgan Lewis - Well Done on

Only weeks after being confirmed, the Department of Health and Human Services (HHS) secretary has advised food companies to remove artificial colors from their food products. He recently met with several major food brand...more

Hogan Lovells

FDA Finalizes Two Food Allergen-Related Guidance Documents

Hogan Lovells on

On January 6, 2025, FDA published two final guidance documents related to food allergens: Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and...more

DLA Piper

FDA Bans Red Dye No. 3 Under the Delaney Clause

DLA Piper on

The US Food and Drug Administration (FDA) has revoked its authorization for the use of FD&C Red No. 3, also known as Red Dye No. 3. Issued on January 15, 2025, the ban will go into effect for food (including dietary...more

Ropes & Gray LLP

2024 FDA Enforcement Review: Quality and Transparency Remain Critical Concerns

Ropes & Gray LLP on

The U.S. Food and Drug Administration (“FDA”), in partnership with the Department of Justice (“DOJ”), pursued significant and, in some cases, precedent-setting enforcement actions in 2024. The government continued to...more

Clark Hill PLC

Red Dye No 3: Old Data Induces New Ban

Clark Hill PLC on

On January 16, 2025 the federal Food and Drug Administration (FDA) issued notice requiring manufacturers to reformulate their products removing Red Dye No. 3 by January 15, 2027 for food (21 CFR §74.303) and January 18, 2028...more

Husch Blackwell LLP

FDA Bans the Use of Red No. 3 in Food and Ingested Drugs

Husch Blackwell LLP on

On January 16, the U.S. Food and Drug Administration (FDA) announced that it is revoking the authorization for use of FD&C Red No. 3 in food (including dietary supplements) and ingested drugs. The dye is commonly used in...more

McDermott Will & Emery

FDA’s Fresh Take on Use of “Healthy” in Food Labeling

McDermott Will & Emery on

On December 19, 2024, the US Food and Drug Administration (FDA) issued a new final rule titled “Food Labeling: Nutrient Content Claims; Definition of Term ‘Healthy.’” The rule revises regulations that govern when food...more

McDermott Will & Emery

Special Report - 2022 FDA Year in Review

McDermott Will & Emery on

As the United States’ primary public health and consumer protection agency, the US Food and Drug Administration (FDA) regulates at least one quarter of the nation’s economy and exerts significant influence over global...more

Arnall Golden Gregory LLP

Tell Me, I’ve Got to Know: FDA Issues Draft Guidance on 506J Notifications for Medical Devices

Arnall Golden Gregory LLP on

Bob Dylan sang, “Tell Me, I’ve Got to Know.” In January 2022, the Food and Drug Administration said the same to the medical device industry when it issued a draft guidance, “Notifying the FDA of a Permanent Discontinuance or...more

Hogan Lovells

Recent FDA Warning Letters focus on inadequate allergen controls following undeclared allergen recalls

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) recently issued a fifth Warning Letter related to allergen labeling, continuing a series of Warning letters in the past six months that cite companies for failing to “identify and...more

Hogan Lovells

FDA Deauthorizes Seven Synthetic Flavorings and Adjuvants as Food Additives

Hogan Lovells on

On October 9, 2018, the U.S. Food and Drug Administration (FDA) issued a final rule revoking authorization for seven synthetic flavorings and adjuvants as food additives. Notably, FDA’s rigorous scientific analysis determined...more

15 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up Log in
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide