Tag Archives: REGULATIONS

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

Prop 65 Site in Sight

California adopts Prop 65 lead agency website regulation. The California Safe Drinking Water and Toxic Enforcement Act of 1986 – also known as “Proposition 65” or “Prop 65” – requires the Governor of California to publish a list of chemicals known to the State to cause cancer or reproductive toxicity.  The list is updated by … Continue Reading

Grounds for ‘Gluten-Free’

FDA Proposes Rule on ‘Gluten-Free’ Requirements for Fermented, Hydrolyzed and Distilled Foods In August 2013, FDA issued a final rule on voluntary “gluten-free” food labeling.  The final rule defined “gluten-free” as meaning that the food either is inherently gluten free or does not contain an ingredient that is: a gluten-containing grain (e.g., spelt wheat); derived … Continue Reading

FSMA Friday

FDA issues three long-awaited final rules to implement FSMA provisions. FDA has issued final rules to implement three major provisions of the FDA Food Safety Modernization Act (FSMA).  The rules are scheduled for publication in the Federal Register on November 27, 2015. Click here for FDA’s overview of the final rule to implement the produce safety … Continue Reading

FSMA Final Rule Watch

FDA finalizes three additional FSMA rules; publication imminent. Although FDA’s implementation of the FDA Food Safety Modernization Act (FSMA) is well underway, the Agency has yet to issue several final rules to implement major provisions of the law.  In 2012, two advocacy groups — the Center for Food Safety and the Center for Environmental Health … Continue Reading

Eye on the EU: Health & Nutrition Claim Regulation

European Commission publishes roadmap to evaluate regulation on health and nutrition claims. As part of its policy to promote “better regulation,” the European Commission recently announced its plan to evaluate two aspects of Regulation 1924/2006/EC on nutrition and health claims:  (1) nutrient profiles; and (2) the use of claims on plants and their preparations. To this effect, the Commission has … Continue Reading

FSMA Final Rule Follow-Up

K&H publishes summaries of FSMA final HARPC rules for human food and animal food. As promised, Keller and Heckman LLP has prepared summaries of FDA’s final rules to implement the hazard analysis and risk-based preventive control (HARPC) provisions for human and animal food under the FDA Food Safety Modernization Act (FSMA). Click here for our summary of … Continue Reading

Vermont’s Guide to GM Labeling

Vermont issues guidance on GM labeling regulations.  Pending the outcome of the ongoing legal challenge to Vermont’s GM labeling law, the law and its implementing regulations are set to take effect on July 1, 2016. On September 23, 2015, the Vermont Attorney General’s Office issued guidance on the state’s interpretation and planned enforcement of the labeling … Continue Reading

FSMA: Final HARPC Rules Published

Federal Register publications available for final rules to implement FSMA HARPC provisions for human and animal food. On September 10, 2015, FDA issued final rules to implement the hazard analysis and risk-based preventive control (HARPC) provisions under the FDA Food Safety Modernization Act (FSMA). On September 17, 2015, the final rules were published in the Federal Register. … Continue Reading

Finally, FSMA

FDA issues long-awaited final rules to implement FSMA HARPC provisions for human and animal food. FDA has issued final rules to implement the hazard analysis and risk-based preventive control (HARPC) provisions under the FDA Food Safety Modernization Act (FSMA).  The rules are scheduled for publication in the Federal Register on September 17, 2015, and the … 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