Archives: Uncategorized

FDA Publishes Goals for Supporting Antimicrobial Stewardship in Veterinary Settings for Fiscal Years 2019-2023

Posted on September 21, 2018

On July 31, 2018, FDA announced that it was working on a five-year blueprint to combat antimicrobial resistance in animals. On September 14, 2018, FDA published Supporting Antimicrobial Stewardship in Veterinary Settings: Goals for Fiscal Years 2019-2023. FDA provides action items to promote three goals; we summarize several major steps for each; Align Antimicrobial Drug … Continue Reading

FDA Commissioner Discusses FDA’s Efforts to Prevent Foodborne Cyclospora Outbreaks

Posted on September 20, 2018

FDA Commissioner Scott Gottlieb has issued a press release in the aftermath of this summer’s Cyclospora (C. cayetanensis) outbreaks in fresh produce, highlighting the Agency’s efforts to prevent outbreaks of this foodborne illlness. Cyclospora is an intestinal parasite that is spread through contamination of food with human waste. FDA has been surveying the food supply … Continue Reading

California Signs Bill Allowing Sale of Home-Cooked Food

Posted on September 19, 2018

California Governor Jerry Brown signed a bill into law on September 18, 2018 which will allow Californians to sell food they make themselves, a practice that was previously outlawed due to health concerns. Assembly Bill 626, also known as the Homemade Food Operations Act, amends California’s Health and Safety Code to establish strict guidelines for … Continue Reading

FSMA Update: FDA Issues Final Q&A Guidance and Attestation Forms for Qualified Facilities Under HARPC Rules

Posted on September 17, 2018

On May 16, 2016 (81 FR 30219), FDA issued a draft guidance document intended to assist “qualified facilities” comply with modified requirements under the hazard analysis and risk-based preventive control (HARPC) provisions of the FDA Food Safety Modernization Act (FSMA). A qualified facility is defined as: (1) a very small business (defined with respect to annual … Continue Reading

Court Rules on Preliminary Motions in NGO Suit on GRAS Rule

Posted on September 14, 2018

On August 17, 2016, FDA finalized the rule – codified at 21 CFR Parts 170 and 570 for human food and animal feed respectively – that was originally proposed on April 17, 1997 permitting manufacturers to reach a Generally Recognized as Safe (GRAS) determination with the option of notifying FDA. Prior to 1997, companies were … Continue Reading

FDA Announces Increased Enforcement to Curb Youth E-Cigarette Use

Posted on September 13, 2018

In a September 12, 2018 press release, FDA announced its largest coordinated enforcement effort in agency history to address what it described as an “epidemic” of e-cigarette use in minors, based on not-yet-released survey data. As part of its enforcement since June 2018, FDA has issued 1,300 warning letters and imposed civil penalties on brick-and-mortar … Continue Reading

FDA Announces Continued Kratom Safety Concerns and Issues Warning Letters to Kratom Marketers

Posted on September 12, 2018

In a press announcement released on September 11, 2018, FDA Commissioner Scott Gottlieb, M.D., emphasized the Agency’s continuing concerns about kratom products. Our readers may remember our previous posts about kratom, also known as Mitragyna speciosa, which is a plant that grows naturally in Thailand, Malaysia, Indonesia, and Papua New Guinea. According to FDA, there … Continue Reading

USDA and FDA Announce Joint Meeting on Animal Cell Culture Technology

Posted on September 11, 2018

Yesterday, the U.S. Department of Agriculture (USDA) and the Food and Drug Administration (FDA) announced that they will hold a joint meeting on October 23-24, 2018, to discuss the use of cell culture technology to develop products derived from livestock and poultry. As we previously reported on this blog, FDA held a public meeting on … Continue Reading

Statement by FDA Commissioner Gottlieb Indicates the Standard “Added Sugar” Declaration Will Not be Required on Nutrition Facts Labels of Pure Maple Syrup and Honey

Posted on September 10, 2018

FDA’s final rule to update the Nutrition Facts label requires a mandatory declaration and a daily value (DV) for “added sugar” for both sweeteners added to processed foods as well as foods “packaged as such” including a bag of table sugar, jar of honey or container of maple syrup. With respect to foods that are … Continue Reading

FDA Issues Draft Guidance for Labeling Supplements with Live Microbials

Posted on September 7, 2018

FDA published a final rule on May 27, 2016 (“Food Labeling: Revision of the Nutrition and Supplement Facts Label”) which updated the requirements for Nutrition and Supplement Facts labels. For more see the Daily Intake blog posts here and here. In the preamble to the rule (81 FR 33742, 33933), FDA addressed a comment suggesting … Continue Reading

USDA Bioengineered Food Labeling Final Rule Sent to OMB for Review

Posted on September 6, 2018

In a sign of progress, the Office of Management and Budget (OMB) received the U.S. Department of Agriculture’s (USDA) final rule for the National Bioengineered Food Disclosure Standard (NBFDS) on August 31, 2018 – less than two months after the comment period closed on the proposed rule for the NBFDS on July 3, 2018. As … Continue Reading

FDA Expands ANAB Recognition under the Accredited Third-Party Certification Program

Posted on September 5, 2018

The Food Safety Modernization Act (FSMA) established the Accredited Third-Party Certification Program, which is a voluntary program that allows “accreditation bodies” to apply for recognition by FDA. Recognized accreditation bodies have the authority to accredit third-party “certification bodies,” otherwise known as third-party auditors. In turn, the certification bodies (1) conduct consultative and/or regulatory food safety … Continue Reading

FDA Announces New Export Certification Program

Posted on September 4, 2018

The U.S. Food and Drug Administration (FDA) recently announced a new export certification program, along with the fees that will be assessed, for certain FDA-regulated food products. The fees will apply to products, such as produce, grains, processed foods, food additives, color additives, food contact substances, and infant formula. “We anticipate that this new export … Continue Reading

FDA Issues Statement Regarding Labeling Coffee as a Carcinogen Consistent with California Proposition 65

Posted on August 31, 2018

California Proposition 65 requires manufacturers to provide clear and reasonable warnings to consumers before exposing them to over 950 listed carcinogens, including acrylamide. As reported in this blog yesterday, California’s regulations for reporting the presence of the carcinogens have changed. Also as previously reported in this blog, producers of roasted coffee have been sued under … Continue Reading

New Proposition 65 Warning Regulations Take Effect Today

Posted on August 30, 2018

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

GFI and Others Sue Missouri over Plant-Based and Clean Meat Labeling Law

Posted on August 28, 2018

The Good Food Institute (GFI), the Animal Legal Defense Fund, the American Civil Liberties Union of Missouri, and Turtle Island Foods (Tofurky brand) sued the state of Missouri over a new law, Mo. Rev. Stat. § 265.494(7), which prohibits labeling a product that is not derived from harvested production livestock or poultry as meat. The … Continue Reading

FDA Recognizes a Fourth Accreditation Body Under FSMA’s VQIP

Posted on August 27, 2018

As previously covered on this blog, the Food Safety Modernization Act (FSMA) established the Voluntary Qualified Importer Program (VQIP) for expediting the review and import entry of human and animal foods into the United States. Certification through FDA’s Accredited Third-Party Certification Program is one of the eligibility criteria for participation in the VQIP. Under … Continue Reading

FDA Extends Deadline for Comments on Nutrition Innovation Strategy

Posted on August 24, 2018

At the National Food Policy Conference in March 2018, FDA Commissioner Scott Gottlieb, M.D., announced the creation of the Nutrition Innovation Strategy (NIS). The NIS is intended to improve public health by educating consumers and encourage innovation to expand the use of nutrition in reducing the instances and impact of chronic disease. FDA held a … Continue Reading

Putative Class Action Challenge to Diet Dr. Pepper in California Fails for the Fourth Time

Posted on August 23, 2018

The Federal District Court for the Northern District of California has granted Dr. Pepper/Seven Up, Inc.’s Motion to Dismiss (available for purchase here) in a putative class action originally filed in October 2017, which alleged that the marketing of Diet Dr. Pepper violated California’s False Advertising Law, Consumer Legal Remedies Act, and Unfair Competition Law, … Continue Reading

CA Judge Certifies Class in Kellogg False Advertising Cereal Lawsuit (Law360 Subscription Required)

Posted on August 22, 2018

On August 17, 2018, a California federal judge certified three classes of consumers who allege that Kellogg falsely advertises its Raisin Bran, Frosted Mini-Wheats, and Smart Start cereals as healthy. The 51-page order granting the motion for class certification found claims that Kellogg misled consumers about the sugar contents of its cereals can be resolved … Continue Reading

California Bill to Require Sugary Beverage Warning Labels Dies in Committee

Posted on August 21, 2018

A bill that would have required warnings on the labels of sugar-sweetened beverages sold in California died in the Senate Appropriations Committee this month (Los Angeles Times). Assemblyman Rob Bonta (D-Alameda) introduced the Sugar-Sweetened Beverage Safety Warning Act, AB 1335, in February 2018. AB 1335 would have banned the sale of sugar-sweetened beverages in sealed … Continue Reading

FSMA Update: FDA Issues Final Q&A Guidance on Food Facility Registration and a New Supplemental Draft Guidance on Registration Requirements for Multiple Entities Using a Shared Space

Posted on August 20, 2018

FDA issued a final rule more than two years ago, on July 14, 2016, to amend and update the Agency’s food facility registration requirements and implement revisions that were mandated by the Food Safety Modernization Act (FSMA). FDA’s compliance guidance for the updated food facility registration requirements was issued in draft on November 7, 2016 … Continue Reading

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