Tag Archives: RULEMAKING

FDA Releases Training Module for Carriers Subject to the Sanitary Transportation Rule

As previously covered on this blog, on April 6, 2016, FDA published a final rule to implement sanitary food transportation requirements under the FDA Food Safety Modernization Act (FSMA).  Click here for a complete copy of the final rule.  Click here for an FDA fact sheet summarizing the final rule, and click here for our summary of the rule and its implications … Continue Reading

GMO Labeling Law Update: USDA Releases Study Exploring Potential Challenges of Using Electronic and Digital Disclosures on Food Labels

As previously reported on this blog, legislation requiring labeling of genetically modified (GM) foods and food ingredients was signed into law on July 29, 2016.  This law, entitled the National Bioengineered Food Disclosure Standard, directs the U.S. Department of Agriculture (USDA) to develop regulations and standards to create mandatory disclosure requirements for bio-engineered foods by July 2018.  Under the … Continue Reading

FDA Releases Compliance Guide for Small Businesses under FSMA Intentional Adulteration Rule

On May 27, 2016, FDA published its final rule to implement the intentional adulteration (or “food defense”) provisions of the FDA Food Safety Modernization Act (FSMA).  Click here for a copy of the final rule.  Click here for an FDA fact sheet summarizing the final rule. In short, the final rule establishes various food defense measures that registered facilities are … Continue Reading

FDA Clarifies Sanitary Transportation Rule Waiver for Retail Food Establishments

As previously covered on this blog, on April 6, 2016, FDA published a final rule to implement sanitary food transportation requirements under the FDA Food Safety Modernization Act (FSMA).  Click here for a complete copy of the final rule.  Click here for an FDA fact sheet summarizing the final rule, and click here for our summary of the rule and its … Continue Reading

FDA Will Exercise Enforcement Discretion for the Use and Labeling of “Ultrafiltered Milk” in Certain Cheeses and Cheese Products

Mechanical filtration technologies available for milk processing include ultrafiltration.  Ultrafiltered milk (UF Milk) is milk that is mechanically filtered via semipermeable membranes to partially remove water, lactose, minerals, and water-soluble vitamins without altering the “casein to whey protein” ratio of the milk and resulting in a liquid product. FDA’s regulations specify the standards of identity … Continue Reading

GM Labeling Rule Update – USDA Extends Deadline for Stakeholder Input

As previously reported on this blog, legislation requiring labeling of genetically modified (GM) foods and food ingredients was signed into law on July 29, 2016.  This law directs the U.S. Department of Agriculture (USDA) to develop regulations and standards to create mandatory disclosure requirements for bio-engineered foods by July 2018.  Under the new law, food companies would have three … Continue Reading

USDA Nutrition Facts Rule Placed on “Inactive” List

On January 19, 2017, USDA’s Food Safety & Inspection Service (FSIS) released a proposed rule to revise its nutrition labeling requirements for meat and poultry products to reflect current scientific research and dietary recommendations. FSIS indicates that the changes parallel FDA’s recently revised nutrition labeling requirements (see our previous blog coverage regarding FDA’s revised nutrition facts requirements here).  … Continue Reading

USDA Publishes Questions to Facilitate Drafting of GMO Labeling Requirements

As previously reported on this blog, legislation requiring labeling of genetically modified (GM) foods and food ingredients was signed into law on July 29, 2016.  This law directs the U.S. Department of Agriculture (USDA) to develop regulations and standards to create mandatory disclosure requirements for bio-engineered foods by July 2018.  Under the new law, food companies would have three … Continue Reading

FDA: No Plans to Reopen Nutrition Facts Label Rule

In May 2016, FDA issued final rules to implement changes to the nutrition labeling and serving size regulations. Mandatory compliance with the new nutrition labeling requirements for food products was initially slated for July 26, 2018 (or July 26, 2019 for manufacturers with less than $10 million in annual food sales).  As covered on this blog last … Continue Reading

“Healthy” Update: Industry, Others Weigh In on ‘Healthy’ Claims

As previously reported on this blog, FDA received a Citizen Petition from KIND in December 2015 requesting that the Agency revisit the definition of “healthy” — which has not changed since 1994 — to take into account present-day scientific understanding about the health benefits of many nutrient-dense foods, and in September 2016, FDA issued a request … Continue Reading

FDA Announces Three Waivers to Sanitary Transportation Rule

By way of background, on April 5, 2016, FDA released a final rule to implement sanitary food transportation requirements under the FDA Food Safety Modernization Act (FSMA).  Click here for a complete copy of the final rule.  Click here for an FDA fact sheet summarizing the final rule, and click here for our summary of the rule and its implications for … Continue Reading

FDA Issues Interim Final Rule Amending Health Claim Requirements

FDA has issued an interim final rule to allow more raw fruits and vegetables to bear health claims concerning the relationship between dietary saturated fat and cholesterol and the risk of coronary heart disease. To make a claim regarding the relationship between dietary saturated fat and cholesterol and the risk of coronary heart disease (CHD) … Continue Reading

Fishy Business: NOAA Finalizes Seafood Traceability Rule

For years, the seafood industry has grappled with the issue of “seafood fraud,” which includes the substitution of cheaper species for more expensive ones.  As previously covered on this blog, on February 5, 2016, the Commerce Department’s National Oceanic and Atmospheric Administration (NOAA) issued a proposed rule to establish a new traceability program for certain seafood … Continue Reading

Import(er) Alert: E-Filing Proposed Rule

FDA proposes e-filing requirements to facilitate product imports. FDA and the U.S. Customs and Border Protection Agency (CBP) work together to facilitate the admission of imported products into the U.S.  The Automated Commercial Environment (ACE) is a commercial trade processing system operated by CBP that helps automate and expedite the processing of imports and exports. Earlier … Continue Reading

Vitamin D-Listed

FDA approves increase in vitamin D added to milk and approves addition to milk alternatives. Many substances added directly to food in the U.S. are marketed on the basis of FDA food additive regulations, which are located in 21 CFR Part 172.  By law, FDA may approve the use of a food additive only after conducting … Continue Reading

FSMA Final Rule: Food Facility Registration

FDA amends food facility registration requirements. Under Section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), facilities that manufacture, process, pack, or hold food for human or animal consumption in the U.S. must register with FDA.  The registration requirement has been in effect since 2003.  However, the FDA Food Safety Modernization Act … Continue Reading

Changes to Nutrition Facts & RACCs (+ Complimentary Webinar)

K&H publishes summaries of final rules to revise nutrition and supplement facts labeling requirements and serving sizes. As promised, Keller and Heckman LLP has prepared summaries of FDA’s recently-issued final rules to implement changes to the nutrition and dietary supplement labeling and serving size regulations. The final rule revising the Nutrition and Supplement Facts Labels:  (1) … Continue Reading

FSMA Final Rule Follow-Up

K&H publishes summary of FSMA final rule to implement intentional adulteration requirements for human food. As promised, Keller and Heckman LLP has prepared a summary of FDA’s final rule to implement the intentional adulteration provisions of the FDA Food Safety Modernization Act (FSMA). Click here for our summary of the rule and its implications for the … Continue Reading

FSMA Final Rule Watch: Intentional Adulteration

FDA releases final rule to implement FSMA intentional adulteration provisions for human food. On May 26, 2016, FDA released its final rule to implement the intentional adulteration (or “food defense”) provisions of the FDA Food Safety Modernization Act (FSMA).  Click here for a pre-publication copy of the final rule.  Click here for an FDA fact sheet … Continue Reading

FDA Final Rule Alert: Revised Nutrition Facts and RACCs

FDA releases final rules to revise nutrition labeling requirements. In 2014, FDA issued proposed rules that would revise the Nutrition Facts label requirements.  The proposals included amendments to the Nutrition and Supplement Facts labels and to longstanding reference amounts customarily consumed (RACCs), which are used to determine serving sizes.  In 2015, FDA issued a supplemental … Continue Reading

Honing in on “Healthy”

FDA to revisit definition of “healthy” on food labels. FDA regulations prescribe qualifying criteria for foods to bear the claim that they are “healthy” (including related terms) (21 CFR 101.65(d)).  Among other factors, a “healthy” food generally must contain 3 grams or less of total fat per serving and 1 gram or less of saturated fat per … Continue Reading

FSMA Final Rule Watch: Whistleblower Protection

OSHA issues final rule implementing FSMA whistleblower provisions. The FDA Food Safety Modernization Act (FSMA) added section 1012 to the Federal Food, Drug, and Cosmetic Act (FD&C Act) to provide added protection for employees who “blow the whistle” and come forward with information about potential food safety problems within their companies or facilities.  Although Section 1012 … Continue Reading

FSMA Final Rule Follow-Up

K&H publishes summary of FSMA final rule to implement sanitary transportation requirements for human and animal food. As promised, Keller and Heckman LLP has prepared a summary of FDA’s final rule to implement sanitary food transportation requirements under the FDA Food Safety Modernization Act (FSMA). Click here for our summary of the rule and its implications … Continue Reading
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