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Podcast: Non-binding Guidance: FDA’s Regulation of Products Containing CBD
Over the first weeks of July 2025, the U.S. Food and Drug Administration (FDA) has issued several announcements heralding new policies and proposed regulatory changes that could dramatically impact the drug, biologics and...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
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
The U.S. Food and Drug Administration (FDA) released a public inventory on July 12, 2023, of certain food ingredients that the agency has determined are unsafe because they are unapproved food additives that are not Generally...more
A salmonella outbreak that sickened hundreds brought the largest criminal penalty ever imposed following a criminal conviction in a food safety case. Our Food & Beverage and White Collar, Government & Internal Investigations...more
While the Food Allergy Safety, Treatment, Education, and Research Act (FASTER Act) only makes a minor change to add sesame as a major food allergen, it signals the government’s intent to closely examine food allergen...more
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
On October 22, 2019, Skadden hosted our Ninth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York, which focused on U.S. enforcement issues companies face throughout the industry. The key...more