Tag Archives: RULEMAKING

FDA Extends Compliance Deadline for New Nutritional Labeling Rules

As our readers are aware, 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 … Continue Reading

Congress Continues to Seek Regulatory Clarity on CBD from FDA

A bipartisan group of members of Congress sent a letter to FDA on September 19 urging the Agency to quickly provide legal clarity and establish a regulatory pathway for food products containing hemp-derived cannabidiol (CBD). “We appreciate FDA’s proactive approach towards pursuing a legal pathway for the production of hemp-derived products containing CBD … However, FDA’s … Continue Reading

San Francisco to Propose Banning Sale of E-Cigarettes

The San Francisco City Attorney, in coordination with the City’s Board of Supervisors, announced on March 20, 2019 that it will introduce legislation to prohibit the sale and delivery of e-cigarettes in the City unless such products have been established as “appropriate for the protection of the public health” through the Food and Drug Administration … Continue Reading

This Week’s Cannabis Highlights

As previously reported in this blog, the 2018 Farm Bill removed hemp – defined as Cannabis sativa L. with less than 0.3% THC on a dry weight basis – from the definition of “marihuana”.  The 2018 Farm Bill also assigned responsibility for regulating the manufacture of hemp to the states under plans approved by USDA … Continue Reading

National Bioengineered Food Disclosure Standard Final Rule Released

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

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

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

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

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

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

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

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

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

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

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
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