Tag Archives: RULEMAKING

National Bioengineered Food Disclosure Standard Final Rule Released

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After much anticipation, the Agricultural Marketing Service (AMS) has released the final rule establishing the national mandatory bioengineered (BE) food disclosure standard. The rule is scheduled to be published on December 21, 2018 in the Federal Register. As previously reported on this blog, the proposed rule was published on May 4, 2018 and approximately 14,000 … Continue Reading

FDA Issues Technical Amendments to Final Nutrition and Supplement Facts Rule

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FDA will publish in the December 21, 2018 Federal Register a final rule that makes technical amendments to its 2016 final rule on Nutrition and Supplement Facts labeling.  The amendments, which are not substantive in nature, affect both 21 C.F.R. 101.9 (“Nutrition labeling of food”) and 21 C.F.R. 101.36 (“Nutrition labeling of dietary supplements”). While … Continue Reading

California Proposes Amendments to Proposition 65 Regulation on the Responsibility to Provide Consumer Product Warnings

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In response to confusion regarding Section 25600.2 of the new Article 6 warning regulations, California’s Office of Environmental Health Hazard Assessment (OEHHA) has proposed amendments to clarify how a product manufacturer—and other parties that may receive the products before the retailer—can pass warning information (and the responsibility to warn) along the supply chain and ultimately … Continue Reading

New Proposition 65 Warning Regulations Take Effect Today

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As previously reported on this blog, in 2016 California passed new regulations redefining what makes a warning “clear and reasonable” under Proposition 65; those regulations become effective today.  Proposition 65 is a right-to-know law that requires manufacturers to provide a clear and reasonable warning to consumers before exposing them to over 950 listed carcinogens and … Continue Reading

European Union’s Top Court Rules on Gene-Editing Technology

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The European Court of Justice has ruled that all techniques that induce DNA mutagenesis result in products that can be regulated as genetically modified organisms.  GMO regulation had previously been limited to products of genetic engineering where DNA from a separate organism was introduced into the target organism’s genome.  Newly developed gene editing techniques exploit … Continue Reading

FDA Confirms Extension of Compliance Dates for Nutrition Labeling and Serving Size Rules; USDA Proposes National Bioengineered (BE) Food Disclosure Rules

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FDA Confirms Extension of Compliance Dates for Nutrition Labeling and Serving Size Rules In the Federal Register for May 4, 2018, FDA issued a final rule that confirms the extension of the compliance dates for two labeling rules from July 26, 2018 to January 1, 2020 for manufacturers with $10 million or more in annual … Continue Reading

FDA Commissioner Scott Gottlieb Comments on Intentional Adulteration

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In the March 28, 2018 FDA Voice blog  Dr. Gottlieb provided background and insight on the Intentional Adulteration rule. The FDA Food Safety Modernization Act (FSMA) charges FDA with addressing the burden of foodborne illness by requiring that producers, importers and distributors of food take systematic steps to prevent contamination. Congress passed FSMA with a … Continue Reading

California Considers Regulating Food Packaging under Green Chemistry Initiative

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As part of its Green Chemistry Initiative and the Safer Consumer Products (SCP) implementing regulations, California’s Department of Toxic Substances Control (DTSC) has released its Draft Three Year Priority Product Work Plan (2018-2020).  The Plan indicates that it will “address exposures from harmful chemicals that migrate from consumer products into food.” DTSC identifies as “Candidate Chemicals” … Continue Reading

GMO Labeling Law Update: CFS Drops USDA Lawsuit Regarding Consumer Study

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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

GMO Labeling Update: Some Senators Calling for On-Package Text to disclose the presence of GM Ingredients

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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 Training Module for Carriers Subject to the Sanitary Transportation Rule

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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
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