The Daily Intake

Legal and Regulatory updates for the food and supplement industry

The Food Safety Modernization Act (FSMA) established the Voluntary Qualified Importer Program (VQIP).  VQIP is intended to expedite the review and import entry of human and animal foods into the United States.  To participate in VQIP, importers must meet eligibility criteria and pay a user fee.  Eligibility criteria include ensuring that the foreign supplier’s facility is certified by a recognized certification body under FDA’s Accredited Third Party Certification Program.  Third-party “certification bodies,” otherwise known as…
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 Product Use with the Principles of Antimicrobial Stewardship Update list of medically important antimicrobial drugs administered in the feed…
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 to monitor for foodborne pathogens and recently added screening for Cyclospora.  The Agency identified Cyclospora in cilantro as part of…
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 “microenterprise home kitchen operations” (MHKs) and goes into effect on January 1, 2019. The legislation limits MHKs to $50,000…
Philadelphia Mayor Jim Kenney signed legislation last Friday that requires chain food establishments to include warning labels on menus next to items containing 2,300 milligrams (mg) or more of sodium. As previously reported on this blog, the Philadelphia City Council unanimously passed the legislation at the end of June 2018. Philadelphia is the second U.S. city to require sodium warning on menus. New York City passed the nation’s first sodium warning policy in 2015.…
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 market value of food sold or held); or (2) a facility with average annual sales of <$500,000 over the…
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 able to submit a GRAS affirmation petition to seek FDA’s approval for a GRAS determination.  GRAS status is important…
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 and online retailers that have sold JUUL and other cartridge-based e-cigarettes, all of which are marketed by large tobacco…
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 is evidence that certain substances found in kratom are opioids and out of concern for the public health, FDA has…
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 the safety of food produced using animal cell cultures a few months ago in July. However, as we noted…