Sara Klock

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Articles

HHS Explores Stronger FDA Oversight For Food Ingredients

1 month ago | mondaq.com | Rachel Gartner |Michael Werner |Sara Klock |Jordan Brossi

U.S. Department of Health and Human Services (HHS) SecretaryRobert F. Kennedy Jr. directed the U.S. Food and DrugAdministration (FDA) to explore potential rulemaking opportunitiesto tighten or eliminate the "generally recognized assafe" (GRAS) standard. The announcement marks the first significant step towardachieving the Trump Administration's goals of promoting healthyfood and "radical transparency" by increasing regulatoryrequirements for food companies and manufacturers.
HHS Explores Stronger FDA Oversight for Food Ingredients | JD Supra

1 month ago | jdsupra.com | Jordan Brossi |Rachel Gartner |Sara Klock

U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. directed the U.S. Food and Drug Administration (FDA) to explore potential rulemaking opportunities to tighten or eliminate the "generally recognized as safe" (GRAS) standard. The announcement marks the first significant step toward achieving the Trump Administration's goals of promoting healthy food and "radical transparency" by increasing regulatory requirements for food companies and manufacturers.
HHS Explores Stronger FDA Oversight for Food Ingredients | JD Supra

1 month ago | foodsafety.einnews.com | Jordan Brossi |Rachel Gartner |Sara Klock

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 rulemaking opportunities to tighten or eliminate current pathways that allow ingredients to be used in food products without premarket approval by the FDA. The statement highlighted two targets for additional scrutiny: a final rule issued by the FDA on Aug.
HHS Explores Stronger FDA Oversight for Food Ingredients

1 month ago | lexology.com | Rachel Gartner |Sara Klock |Jordan Brossi

Highlights U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. directed the U.S. Food and Drug Administration (FDA) to explore potential rulemaking opportunities to tighten or eliminate the "generally recognized as safe" (GRAS) standard.
FDA's New Year, New Rules: Labeling For Healthier Choices

Jan 23, 2025 | mondaq.com | Rachel Gartner |Sara Klock |Parker Reynolds

As part of the Biden Administration's concluding acts, theU.S. Food and Drug Administration (FDA) has released a final ruleto update the definition of "healthy" when used as animplied nutrient content claim in food labeling. The compliancedate for the final rule is Feb. 25, 2028. The FDA also proposed a rule that mandates front-of-packagenutrition labeling, for which stakeholders have until May 16, 2025,to submit comments.
FDA's New Year, New Rules: Labeling for Healthier Choices | JD Supra

Jan 20, 2025 | jdsupra.com | Rachel Gartner |Sara Klock |Parker Reynolds

As part of the Biden Administration's concluding acts, the U.S. Food and Drug Administration (FDA) has released a final rule to update the definition of "healthy" when used as an implied nutrient content claim in food labeling. The compliance date for the final rule is Feb. 25, 2028. The FDA also proposed a rule that mandates front-of-package nutrition labeling, for which stakeholders have until May 16, 2025, to submit comments.
FDA Rejects Application For Psychedelic Drug

Aug 13, 2024 | mondaq.com | Michael Werner |Sara Klock

The U.S. Food and Drug Administration (FDA or Agency) rejected the new drug application (NDA) for a drug marketing approval submitted by Lykos Therapeutics Inc. (Lykos) for its psychedelic MDMA drug on Aug. 9, 2024. Lykos submitted the application to secure FDA approval for use of the drug to treat post-traumatic stress disorder (PTSD). No other such psychedelic drug product is on the market.
FDA Rejects Application for Psychedelic Drug | JD Supra

Aug 12, 2024 | jdsupra.com | Sara Klock |Michael Werner

The U.S. Food and Drug Administration (FDA or Agency) rejected the new drug application (NDA) for a drug marketing approval submitted by Lykos Therapeutics Inc. (Lykos) for its psychedelic MDMA drug on Aug. 9, 2024. Lykos submitted the application to secure FDA approval for use of the drug to treat post-traumatic stress disorder (PTSD). No other such psychedelic drug product is on the market.
FDA Rejects Application for Psychedelic Drug

Aug 12, 2024 | lexology.com | Sara Klock

The U.S. Food and Drug Administration (FDA or Agency) rejected the new drug application (NDA) for a drug marketing approval submitted by Lykos Therapeutics Inc. (Lykos) for its psychedelic MDMA drug on Aug. 9, 2024. Lykos submitted the application to secure FDA approval for use of the drug to treat post-traumatic stress disorder (PTSD). No other such psychedelic drug product is on the market.
Congress Advances Cannabis and Hemp Proposals | JD Supra

Jul 29, 2024 | jdsupra.com | Sara Klock |Elizabeth Leoty Craddock |Peter Tabor

Recent congressional activity highlights the changing environment for cannabis regulation. Specifically, U.S. Congress is moving forward with legislation that will change the regulation of hemp-derived products. The industry could see changes as early as this fall, although it's more likely to be in the first quarter of 2025.