The Daily Intake

Legal and Regulatory updates for the food and supplement industry

  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 and was updated – again in draft – on December 27, 2016.  (See previous blog coverage here.) On August…
FDA Commissioner Scott Gottlieb, MD, issued a statement on August 16 regarding the role of microorganisms on health.  Dr. Gottlieb provided background on the use and regulatory status of microorganisms. Also in his statement, Commissioner Gottlieb provided the underlying rationale for his statement via the example of probiotics administered to premature infants as a preventive measure against a serious disease called  necrotizing enterocolitis.  He pointed out that there have been both benefits and serious side…
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 Q&A explains that, unlike HARPC for human food, FDA decided to stagger the compliance dates for HARPC and related Current
On August 14, 2018, FDA released a constituent update regarding the upcoming compliance dates for the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals final rule under the Food Safety Modernization Act (FSMA). By September 17, 2018, both large and small animal food facilities must comply with preventive controls requirements mandated by FSMA. Large businesses are those with 500 or more full-time equivalent employees, and small businesses are those…
The U.S. Department of Agriculture’s (USDA) proposed rule for the National Bioengineered Food Disclosure Standard (NBFDS) originally included three alternative symbols for the symbol disclosure option to label bioengineered (or, “BE”) foods: 2-A                     2-B                     2-C USDA also included a supplemental document to the proposed rule with the color versions. The preamble to the proposed rule specifically…
•       As reported by numerous media outlets, a San Francisco jury (in state court) on August 10, 2018 delivered a verdict against Monsanto of $289 million, including $250 million in punitive damages, for a former school groundskeeper dying of non-Hodgkin’s lymphoma.  The plaintiff, Dewayne Johnson, proved to the jury that Roundup herbicide was a “substantial contributing factor” in causing his cancer and that Monsanto failed to warn consumers about the product’s cancer risk.  Monsanto has…
In a Wall Street Journal op-ed, Dr. Henry Miller, the former founding director of the FDA’s Office of Biotechnology, criticizes FDA as giving organic food labeling and advertisement “a complete pass.”  The author calls out FDA’s lack of enforcement on claims that organic foods are grown “without toxic or persistent pesticides,” noting that in fact, organic farmers rely on synthetic and natural pesticides to grow their crops (just as conventional farmers do), and organic products…
A class action lawsuit has been filed against Rachel Ray’s Nutrish dog food brand, alleging that “natural” claims were false and misleading under state consumer protection laws, based on testing that showed the presence of glyphosate residues. Glyphosate, commonly known as Roundup®, is an EPA-approved herbicide that is used on food crops, including crops that have been genetically modified to be resistant to glyphosate (e.g., canola, corn, soy, sugar beet, and wheat). While many human foods…
On July 31 and August 1, 2018, the U.S. Food and Drug Administration (FDA) participated in a meeting of the Leafy Greens Food Safety Task Force that was formed in response to the outbreak of E. coli O157:H7 associated with romaine lettuce from Yuma, Arizona that occurred earlier this year. During the meeting, FDA shared preliminary hypotheses about possible outbreak causes and the actions necessary to prevent a future occurrence. FDA has previously mentioned that…
The 2016 National Bioengineered Food Disclosure Standards (NBFDS) Act directs the U.S. Department of Agriculture (USDA) to develop regulations and standards to create mandatory disclosure requirements for bioengineered (BE) foods by July 2018. The Center for Food Safety (CFS) and the Center for Environmental Health (CEH) filed a lawsuit in the Northern California U.S. District Court on August 1 citing USDA’s failure to meet that deadline. Agriculture Secretary Sonny Perdue; Bruce Summers, Administrator, USDA’s Agricultural Marketing Service; and…