Medical Device Legal News with Sam Bernstein: Episode 11
In September 2022, former President Biden convened the White House Conference on Hunger, Nutrition, and Health, during which the White House introduced its National Strategy on Nutrition and Health (National Strategy). The...more
FDA issues final guidance on lead in baby food. FDA has issued its Final Guidance on Action Levels for Lead in Processed Food Intended for Babies and Young Children as part of its Closer to Zero initiative to reduce dietary...more
On January 6, 2025, the U.S. Food and Drug Administration (FDA) issued draft guidance on the labeling of plant-based alternatives to animal-derived foods. The draft guidance provides best practices for naming plant-based...more
On August 15, 2024, the U.S. Food and Drug Administration (FDA) issued draft guidance with new, voluntary sodium reduction targets for foods, with the goal of reducing sodium intake to 2,750 milligrams (mg) per day from the...more
LEGISLATION, REGULATIONS & STANDARDS - FDA Announces Draft Guidance for Sodium Reduction Efforts - The U.S. Food and Drug Administration (FDA) has issued draft guidance that would support reducing the average individual...more
The U.S. Food and Drug Administration (FDA) recently issued a new food allergen-focused chapter of its Hazard Analysis and Risk-Based Preventive Controls for Human Food draft guidance. The new chapter addresses allergen...more
On September 26, 2023, the U.S. Food & Drug Administration (FDA) added two new chapters to the agency’s draft guidance (the Draft Guidance): Chapter 11: Food Allergen Program and Chapter 16: Acidified Foods. These additions...more
On July 6, 2023, the U.S. Food and Drug Administration (“FDA”) released an updated list of draft and final topics that the agency anticipates publishing guidance documents for by the end of December 2023....more
The U.S. Food and Drug Administration (FDA) is requesting comment on the availability of nutrition, ingredient, and allergen information online for packaged foods sold through online grocery shopping platforms. FDA explains...more
The FDA is catching up with the increase in demand for plant-based milks that has occurred throughout the last ten years. There is no established standard for the compositional requirements of plant-based milk alternatives...more
On February 23, 2023, the Food and Drug Administration (FDA) announced the issuance of a draft guidance document entitled “Labeling of Plant-Based Milk Alternatives and Voluntary Nutrient Statements: Guidance for Industry.”...more
In 2018, when former FDA Commissioner Scott Gottlieb famously commented that “an almond doesn’t lactate,” he was adding perhaps the most colorful volley in a long-simmering debate about how the Food and Drug Administration...more
The Food and Drug Administration (FDA) has released draft guidance for the labeling of plant-based milk alternatives, which could have a significant impact on the way these products are marketed and sold. The proposed...more
Following several years of lead-up, including public engagement, the review of more than 13,000 comments, and conducting focus group studies, on February 22, 2023, the U.S. Food and Drug Administration ("FDA") issued a draft...more
On February 22, 2023, the U.S. Food and Drug Administration (FDA) issued a draft guidance document recommending that plant-based alternative milks that use “milk” in the name (e.g., “soy milk”, “almond milk,” “oat milk”), and...more
The U.S. Food and Drug Administration (FDA) recently published draft guidance that explains the approach the agency intends to take when evaluating the public health importance of food allergens that are not one of the nine...more
Last week, FDA issued a draft guidance that outlines the agency’s proposed approach for evaluating the public health importance of food allergens other than the eight major food allergens identified by US law, which are milk,...more
The U.S. Department of Agriculture’s (USDA’s) Agricultural Marketing Service (AMS) is seeking public comment on draft instructions to validate a refining process under the National Bioengineered Food Disclosure Standard...more
The U.S. Food and Drug Administration (FDA) recently issued a draft guidance to advise food manufacturers of its intent to exercise enforcement discretion for the name “potassium chloride salt” in the ingredient statement on...more
Last week the Food and Drug Administration (FDA) issued draft guidance announcing that the agency intends to exercise enforcement discretion to allow the use of “potassium chloride salt” as an alternative common or usual name...more
Last week, the FDA released a draft guidance regarding the low calorie sweetener, allulose, and stated the agency will not treat this ingredient as contributing to total or added sugars content in the nutrition information....more
The U.S. Food and Drug Administration (FDA) recently issued two guidance documents – one final and one draft – related to the new nutrition labeling requirements. The final guidance is an update to the previous draft guidance...more
Silverman Publishes “In Search of the Reasonable Consumer: When Courts Find Food Class Action Litigation Goes Too Far” - Shook Partner Cary Silverman has authored an article for the University of Cincinnati Law Review...more
Draft Guidance on Food Recalls Issued - The U.S. Food and Drug Administration (FDA) has issued draft guidance on the release of retailer information during the food-recall process. The guidance indicates when the agency...more
USDA Inspector General Recommends Reform of AMS Organic Program for Imports - The USDA Inspector General ("IG") reviewed the Agricultural Marketing Service's ("AMS") process used in determining whether exporting...more