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
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The U.S. Food and Drug Administration (FDA) issued a draft guidance for industry on Action Levels for Lead in Food Intended for Babies and Young Children (Draft Guidance). The proposed action levels would apply to processed...more
On November 29, the U.S. Food and Drug Administration (FDA) issued two guidance documents about food allergen labeling requirements. First, FDA issued a draft guidance titled Questions and Answers Regarding Food Allergens,...more
The U.S. Food & Drug Administration (FDA) recently issued Warning Letters to five companies selling products containing delta-8 tetrahydrocannabinol (delta-8 THC) and cannabidiol (CBD). In addition to the various violations...more
The U.S. District Court for the Southern District of New York granted the U.S. Food and Drug Administration’s (FDA or the Agency) motion for summary judgment on September 30, 2021, against claims brought by a group of...more
On 14 April 2021, the U.S. Congress passed the Food Allergy Safety, Treatment, Education, and Research (FASTER) Act of 2021 (S. 578), which now heads to the White House for signature. ...more
Last week, members of both chambers of Congress announced the introduction of new legislation – the Baby Food Safety Act of 2021 – that would establish limitations on the levels of certain heavy metals in infant and toddler...more
On 10 November 2020, the U.S. Food and Drug Administration (FDA) announced the availability of a draft guidance recommending that companies voluntarily declare sesame in the ingredient list when it is used as a “flavor” or...more
11/12/2020
/ Federal Food Drug and Cosmetic Act (FFDCA) ,
Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) ,
Food Allergies ,
Food and Drug Administration (FDA) ,
Food Labeling ,
Food Manufacturers ,
Food Safety ,
Food Supply ,
Public Health ,
Retail Market ,
Voluntary Disclosure
The Council for Responsible Nutrition (CRN) submitted a citizen petition to the Food and Drug Administration (FDA) requesting that FDA:
FDA exercise its statutory authority to establish a regulation under which...more
6/26/2020
/ Agribusiness ,
Cannabidiol (CBD) oil ,
Cannabis Products ,
Citizen Petitions ,
Dietary Supplements ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Hemp ,
Marijuana ,
Medical Foods ,
Plant Based Products ,
Regulatory Oversight ,
Rulemaking Process
Many food and beverage companies are assessing the use of hemp-derived ingredients in their products in light of the 2018 Farm Bill provisions excluding “hemp” from the definition of marijuana under the federal Controlled...more
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
10/30/2018
/ Additive Manufacturing ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Food Labeling ,
Food Safety ,
Food Supply ,
Proposition 65 ,
Public Health ,
Regulatory Oversight ,
Regulatory Requirements ,
Toxic Exposure