Tag Archives: FDA

FDA to Redefine “Healthy;” Requests Public Comment and Issues New Guidance

FDA hinted in May that it was planning to reconsider its longstanding and controversial criteria for using the term “healthy.”  Today, it announced the beginning of the formal process to make changes to the definition of the term.  The agency opened a new docket and is publishing a Request for Information and Comments relating to … Continue Reading

Senators Reach Compromise on GMO Labeling Bill

Yesterday, U.S. Senate Agriculture Committee Chairman Pat Roberts, R-Kan., and Ranking Member Debbie Stabenow, D-Mich., announced a bipartisan compromise bill regarding labeling of bioengineered foods, sometimes referred to as “genetically modified organisms” or “GMOs.”  They stated, “This bipartisan agreement is an important path forward that represents a true compromise. Since time is of the essence, … Continue Reading

FDA Finalizes Additional Guidance on Medical Foods; Continues to Take Narrow View of Category

fda-logo-1_10770329FDA has finalized its guidance document relating to medical foods, a special class of products defined under the Orphan Drug Act. Although most of the content of the final guidance mirrors the draft guidance released in August 2013, the final guidance clarifies the following points: Medical foods are exempt from the labeling requirements for nutrient … Continue Reading

FDA to Chew Over Meaning of “Healthy”

Although “healthy” might sound like a subjective term, FDA has long-defined “healthy” under nutrient content claim regulations. For example, to be “healthy” an item must be low in fat and saturated fat.  Many stakeholders and health advocates have argued that this conception of “healthy” may be outdated, and the agency hinted this week that it … Continue Reading

FDA Proposes Gluten-Free Labeling Standards for Fermented and Hydrolyzed Foods

Word gluten free written in white flour on a old wooden table from top view in vintage tone, surrounding by baking tools.On November 18, 2015, the FDA issued a proposed rule to set standards for making a “gluten-free” claim for foods that are fermented, hydrolyzed, or distilled, or that otherwise contain fermented or hydrolyzed ingredients. The proposed rule builds on the FDA’s 2013 final rule defining the term “gluten-free” for voluntary use in labeling of foods. … Continue Reading

FDA Requests Public Comment on How “Natural” Claims Should be Regulated; Opening 90-Day Comment Period

FDA is requesting public comment on how “natural” claims should be regulated. The 90-day public comment period will open on November 12, 2015, when the FDA notice is published in the Federal Register.  In particular, FDA seeks information and public comment relating to a number of specific issues, including the following: Should FDA define the … Continue Reading

Sunscreen Innovation Act Changes FDA Review Process for More Than Just OTC Sunscreens

On November 26, 2014, the President signed into law the Sunscreen Innovation Act (Pub. L. No. 113-195).  The Act is primarily intended expedite FDA procedures for approving new sunscreen active ingredients and ingredient blends for use in nonprescription sunscreen products under the Federal Food Drug and Cosmetics Act, and address the current backlog of sunscreen … Continue Reading

FDA Proposes Significant Changes to RACCs and Serving Size Requirements

In conjunction with the proposed changes to the nutrition labeling requirements, the FDA is separately issuing a proposed rule that would make significant changes to “reference amounts customarily consumed” (“RACCs”) for certain foods, and existing requirements governing the declaration of serving sizes for nutrition labeling purposes.  Existing FDA regulations prescribe the “RACC” for foods on a … Continue Reading

Heightened FDA Activity Related to OTC Drugs Expected in 2013

According to the 2013 unified agenda for the Department of Health and Human Services, FDA plans to recommend several changes to U.S. OTC drug labeling, safety monitoring, and manufacturing standards in 2013 which may impact future marketing and product development strategies for consumer products. Forthcoming FDA proposals include the following:  Proposed Monograph Modifications  Amending the … Continue Reading

FDA Releases Guidance on Implementation of FSMA Fee Provisions

The Food and Drug Administration (“FDA”) has released a question and answer guide to its implementation of the fee provisions of the Food Safety Modernization Act of 2011. The purpose of the fee provisions is to allow the FDA to recover reinspection, recall noncompliance, and importer program related costs from domestic and foreign facilities and … Continue Reading
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