Tag Archives: REGULATIONS

FDA to Strengthen Dietary Supplements Regulation

On February 11, FDA Commissioner Scott Gottlieb, M.D. announced a new plan for modernizing and strengthening dietary supplement regulation and oversight. In making the announcement, Dr. Gottlieb pointed out that supplement use is increasing with three out of every four American consumers taking a dietary supplement on a regular basis. Also, since Congress passed the … Continue Reading

Cannabis Quick Hits

A look at some recent news that we are following: There has been a lot of action in state legislatures towards legalization of cannabis for medical use, recreational use, or both.  A recent Boston Globe article addresses the ten states where legalization is most likely this year. New York state appears to have had a … 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

FDA Removes Clearance for 7 Synthetic Flavoring Substances

As we previously reported on this blog, a group of non-government organizations (NGOs) sued FDA in an effort to compel the Agency to act on a Food Additive Petition (FAP) concerning seven synthetic flavoring food additives. The FAP, which the NGOs submitted to FDA, requested that FDA remove the clearances for these seven synthetically derived … 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

FDA Releases Q&A for Preventive Controls for Animal Foods

In light of the approaching September 17, 2018 compliance date for small animal food businesses (i.e., those with less than 500 full-time equivalent employees) to comply with Hazard Analysis and Risk-Based Preventive Controls (HARPC) rules, FDA has released a Q&A document concerning what to expect in the near term regarding FDA enforcement and inspections. The … Continue Reading

Non-Profits Sue FDA to Prohibit Use of Seven Flavors

Eight non-profit organizations (Breast Cancer Prevention Partners, Center for Environmental Health, Center for Food Safety, Center for Science in the Public Interest, Environmental Defense Fund, Environmental Working Group, Natural Resources Defense Council, and WE ACT for Environmental Justice) are suing FDA to seek a prohibition on the use of various flavors in food.  The lawsuit … Continue Reading

FDA Releases Intentional Adulteration Training Course

In partnership with the Food Safety Preventive Controls Alliance (FSPCA), FDA has developed a free 30-minute “Food Defense Awareness for the Intentional Adulteration (IA) Rule” online training course to assist industry in complying with Food Safety Modernization Act (FSMA) requirements under the Final Rules for Mitigation Strategies to Protect Food Against Intentional Adulteration. The training … Continue Reading

California Court Upholds Labor Code Listing Mechanism in Monsanto Glyphosate Case

A California Court of Appeals has rejected various arguments made by Monsanto Company, challenging the listing of glyphosate based on the Proposition 65 Labor Code listing mechanism, where carcinogens listed by the International Agency for Research on Cancer are automatically listed under Proposition 65. The court did not agree that the Labor Code listing of … Continue Reading

FDA Commissioner Gottlieb indicates future of FDA’s role in defining claims such as “healthy”

As previously reported on this blog, the Food and Drug Administration (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.  In September … 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

FDA Requests Input on Reducing Regulations

As previously reported on this blog, the White House  issued Executive Order 13771, “Reducing Regulation and Controlling Regulatory Costs” on January 30, 2017. A few weeks later, on February 24, 2017, the White House issued Executive Order 13777, which directs each Agency to establish a Regulatory Reform Task Force (RRTF) to evaluate existing regulations and … 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 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

Food Groups Express Concern about Impact of Recent Presidential Orders

The potential impact on FDA of several executive orders issued within weeks of President Donald Trump taking office has raised concerns. A January 20, 2017 memorandum from White House Chief of Staff Reince Priebus to the heads of executive departments and agencies titled, “Regulatory Freeze Pending Review,” states that new regulations must be reviewed by … Continue Reading

New Settlement Terms for California’s Prop 65 Become Effective Oct. 1

Amendments to California’s Proposition 65 settlement terms, penalty amounts, and attorney’s fees in civil actions filed by private persons become effective October 1, 2016. By way of background, Proposition 65—also known as the Safe Drinking Water and Toxic Enforcement Act of 1986—prohibits knowingly exposing any individual to a listed chemical without first providing a “clear … 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 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

Gluten-Free Go-Round

FDA extends comment period on proposed rule for gluten-free labeling of fermented or hydrolyzed foods. As previously covered on this blog, FDA issued a proposed rule to address the application of “gluten-free” labeling requirements to fermented and hydrolyzed foods and foods that contain fermented and hydrolyzed ingredients.  The underlying issue is that uncertainty prevails in interpreting … Continue Reading
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