Can Food Really Be Medicine? Transforming Health Care One Bite at a Time – Diagnosing Health Care Video Podcast
Federal Court Strikes Down FDA Rule on LDTs - Thought Leaders in Health Law®
Podcast - Hot Topics in FDA Regulation: GLP-1s, LDTs, AI and More
Prescribing GLP-1 Medications: Be Aware of Legal Limitations
AGG Talks: Cross-Border Business Podcast - Episode 22: What Global Companies Need to Know About Navigating FDA Regulations and U.S. Market Entry
AI and Pharmacovigilance Under the FDA's New Emerging Drug Safety Technology Program – The Good Bot Podcast
GLP-1 Drugs and Cultivated Meat: What’s the Impact on the Food and Agriculture Industry?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 202: Life Sciences Startups and Industry Developments with Gil Price, Life Sciences Leader
The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
Video: Food for Thought and Thoughts on Food: Innovating USDA Science with Sanah Baig, Deputy Under Secretary for Research, Education, and Economics
The FDA's Response to AI Medical Innovation — The Good Bot Podcast
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Litigating Nutrition: Class Action Battles Over Dietary Supplements – Speaking of Litigation Video Podcast
Changes in FDA, Cannabis Policies and AI Developments
Ad Law Tool Kit Show – Episode 2 – Marketing FDA-Regulated Products
Medical Device Legal News with Sam Bernstein: Episode 18
Medical Device Legal News with Sam Bernstein: Episode 17
A Look Into the FDA and USDA Regulatory Regimes
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
On March 31, 2025, Congress saw the reintroduction of H.R. 2511, the Sarah Katz Caffeine Safety Act. The bill would amend the Federal Food, Drug, and Cosmetic Act to establish new regulatory requirements for labeling the...more
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
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
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
The Secretary of the U.S. Department of Health and Human Services (HHS), Robert F. Kennedy, Jr., recently issued a press release directing the Food and Drug Administration (FDA) to take steps to explore possible rulemaking to...more
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
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
U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. announced on March 10, 2025, that he directed the acting commissioner of the U.S. Food and Drug Administration (FDA) to explore potential...more
The U.S. Food and Drug Administration (FDA) issued a final guidance for industry titled Action Levels for Lead in Processed Food Intended for Babies and Young Children (Final Guidance). The final action levels apply only to...more
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
The U.S. Food and Drug Administration (FDA) recently approved the marketing of 20 Zyn nicotine pouches, marking the first time nicotine pouches have received such authorization. This decision came through the premarket...more
Among the wave of guidance documents issued by the U.S. Food and Drug Administration (“FDA” or the “Agency”) in the first week of 2025 were three notable draft guidance documents pertaining to medical devices (together, the...more
On January 16, 2025, the U.S. Food and Drug Administration (“FDA”) published a highly anticipated proposed rule on front-of-package (“FOP”) nutrition labeling (“proposed rule”)....more
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
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
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
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
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
On January 15, 2025, FDA announced an order revoking the listings providing for the use of the color additive FD&C Red No. 3 in both foods (including dietary supplements) and ingested drugs. The order is in response to a 2022...more
On December 19, 2024, the U.S. Food and Drug Administration (FDA) issued its long-awaited final rule updating the requirements for when the term “healthy” can be used as an implied nutrient content claim in food labeling. ...more
Mandatory testing of talc-containing cosmetic products is coming. At the end of December, the Food and Drug Administration (FDA) proposed a cosmetics rule and test method for asbestos in talc that was required under Section...more
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
In a concerted effort to combat the illegal sale of delta-8 THC edibles packaged to look like popular snacks, the US Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) have recently begun issuing...more
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more
Methylene chloride, also known as dirchloromethane [osha.gov], is a volatile, colorless liquid with a chloroform like odor. Historically, it has been used in various industrial processes, such as pharmaceutical manufacturing,...more