Tag Archives: REGULATIONS

California Department of Toxic Substances Control Considering Prioritization of Ortho-phthalates, Bisphenol A, and Perfluoroalkyl and Polyfluoroalkyl Substances in Food Packaging

Last week, California’s Department of Toxic Substances Control (DTSC) hosted a webinar where it presented initial findings from its evaluation of food packaging, conducted under its Safer Consumer Products Regulations.  During the webinar, DTSC noted that it is considering the prioritization of ortho-phthalates (OPs), bisphenol A (BPA), perfluoroalkyl and polyfluoroalkyl substances (PFASs), and/or styrene in … Continue Reading

USDA Announces Renewal of Substance Exemptions in the National Organic Program

As previously discussed on this blog, there is a National List of Allowed and Prohibited Substances (the “National List”) for synthetic and nonsynthetic nonagricultural (nonorganic) substances that may be used in organic handling, and nonsynthetic substances prohibited from use in organic farming under the National Organic Program (NOP) administered by the United Stated Department of … Continue Reading

A Look at the Food Handler Antiseptic OTC Rulemaking

On December 7, 2018, the Food and Drug Administration (FDA) established a docket and requested data, information, and comments to “assist the Agency in assessing the safety and effectiveness of food handler antiseptic drug products (i.e., antiseptic hand washes or rubs intended for use in food handling settings) for over-the-counter (OTC) human use.”  The request … Continue Reading

FDA Publishes Final Rule on Tolerances for Animal Drugs in Food

On July 10 FDA finalized its rule on Updating Tolerances for Residues of New Animal Drugs in Food.  This rule was originally proposed in 2012 with a revision proposed in 2016.  The rule will become effective September 9. As described in the Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM) Update, the new … Continue Reading

Looking Ahead: Proposed Regulatory Actions by FDA and USDA in the Fall 2018 Unified Agenda

The Executive Office of the President recently released the Spring 2019 Unified Agenda. As we described in our post for the release of the Fall 2018 Unified Agenda, twice a year, federal agencies publish this comprehensive report describing regulations currently under development or recently completed. The agenda provides stakeholders with a preview of agencies’ top … Continue Reading

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
LexBlog

We and our analytics and advertising providers may use cookies and similar technologies to enhance the browsing experience, facilitate sharing of content, and generate statistics about use of the website. For more information or to change your preferences, click here.

I Agree