VQIP Application Portal Will Open October 1st for the Fiscal Year 2020 Benefit Period

Please feel free to contact Keller and Heckman at fooddrug@khlaw.com with any questions about the VQIP.

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

  • 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 or water of food producing animals;
    • Issue draft strategies to ensure that all medically important antimicrobial drugs have appropriate durations of use when used in food or feed and all medically important antimicrobial drugs are under the supervision of a licensed veterinarian;
    • Engage stakeholders on improvement of labeling to support antimicrobial stewardship;
    • Obtain public input on antimicrobial use practices in companion animals, ensure that all dosage forms are used under the oversight of a licensed veterinarian, and develop and implement a strategy for promoting antimicrobial stewardship in companion animals; and
    • Collaborate with stakeholders to identify ways to encourage development of antimicrobial alternatives.
  • Foster Antimicrobial Stewardship in Veterinary Settings
    • In consultation with USDA, work with stakeholders to identify ways to develop, update, and disseminate information on antimicrobial stewardship and assist academic and federal partners to develop educational materials that address antimicrobial stewardship;
    • Increase access to antimicrobial label information; and
    • Develop position to promote international antimicrobial stewardship and provide technical assistance to developing countries.
  • Enhance Monitoring of Antimicrobial Resistance and Antimicrobial Drug Use in Animals
    • Continue collecting data on on-farm antimicrobial use in U.S. animal agriculture in poultry, swine, and cattle first funded in 2016;
    • Expand antimicrobial resistance screening for additional bacteria species and to characterize resistance in bacteria;
    • Expand information technology systems to promote coordination;
    • Expand surveillance to retail meat sampling; and
    • Characterize and include genomic information in reports.
  • Please contact Keller and Heckman at fooddrug@khlaw.com for assistance preparing comments on the goals document or in engaging in FDA’s policy development.

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

  • 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 its ongoing surveillance this past summer.  The cilantro, which was grown in the U.S., was not associated with any illnesses; it marks the first time that Cyclospora has been identified in a domestically-grown produce item.  Gottlieb also stressed the importance of FDA’s Produce Safety rule under the Food Safety Modernization Act (FSMA) as a means for preventing foodborne illnesses at the farm level.
  • According to the Centers for Disease Control, there have been 2,173 lab-confirmed cases of Cyclospora in the U.S., across 33 states; less than half of these illnesses arose out of two outbreaks from May through August of 2018 from salad mix (511 cases) and from fresh produce trays with dips (250 cases).  This marks an increased incidence of infection; however, some of this increase may be due in part to improved detection methods, rather than an increase in Cyclospora contamination in the food supply.

 

California Signs Bill Allowing Sale of Home-Cooked Food

  • 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 in sales a year, and 60 individual meals a week.  The food must be prepared, cooked, and served on the same day and picked up by the customer or delivered within a safe time period.  Indirect sales are prohibited – customers must either pick up the food from the cook, or the cook must deliver it directly to the customers.  However, MHKs are exempt from certain food service facility requirements that are required of commercial kitchens, such as three-compartment sinks.
  • Assembly Bill 626 aims to quell any concerns about food safety by requiring MHK operators to be permitted and subject to state health inspections.  The bill also allows city and county health departments to opt in to the new law, if they wish.  MHK operators will be required to obtain food manager training and certification.  MHK operators will bear the costs of permitting and annual inspections, which add up to about $300 per year.  The total cost to launch a MHK is estimated to be $800 a year, including liability insurance, although such insurance is not required.
  • Prior to the passage of Assembly Bill 626, California restricted the ways by which individuals could sell food: (1) through commercial food facilities, or (2) through the Cottage Food Act, which allows the sale of mostly non-perishable foods, such as baked goods without cream or meat fillings, candy, chips, and jams.

Philadelphia Mayor Signs Bill Requiring Sodium Warning on Menus

  • 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.
  • While Philadelphia’s sodium labeling law took effect on September 14, 2018, the City won’t start enforcing the new rules until September 14, 2019. For the first three months, the Philadelphia Department of Health will only issue a warning. After December 14, 2019, the City will issue tickets that include fines. Chain retail food establishments include, but are not limited to, restaurants, convenience stores, delis, bakeries, grocery store food counters and coffee shops. Businesses that are not able to meet the compliance deadline may apply for a six-month extension.
  • “Of the nation’s 10 largest cities, Philadelphia has the highest rate of high blood pressure,” said Mayor Kenney in a press release about the new law. The mayor added that decreasing sodium consumption has the potential to lower high blood pressure rates by 25%. The average American consumes 3,400 mg of sodium per day. The Daily Value for sodium is 2,300 mg per day – Daily Values are reference amounts of nutrients to consume or not to exceed each day for adults and children 4 years of age and older, as determined by the U.S. Food and Drug Administration (FDA).
  • The bill was originally introduced by Philadelphia Councilmember Blondell Reynolds Brown. When the bill was signed into law, she stated, “It is incredibly empowering to all Philadelphia’s consumers to know exactly, and quite literally, what they are consuming, especially when their menu choices can negatively affect their health.” It remains to be seen if other jurisdictions will introduce similar measures.

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

  • 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 prior 3-year period and with at least 50% of sales directly to consumers or to local retailers or restaurants (within the same state or within 275 miles of facility).  21 CFR 117.3 (human food); 21 CFR 507.3 (animal food).  Under the modified requirements, a business must submit a form to FDA, attesting to its status as a qualified facility.  (See previous blog coverage here.)
  • On September 14, 2018, FDA announced the availability of the finalized guidance document titled Determination of Status as a Qualified Facility Under Part 117: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food And Part 507: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals.  (See also 83 Fed. Reg. 46878, September 17, 2018.)  FDA concurrently announced the release of the required attestation forms, Form FDA 3942a for facilities subject to the PC Human Food rule, and Form FDA 3942b for facilities subject to the PC Animal Food Rule, along with instructions on how to fill them out and how they should be submitted.
  • Changes to the guidance were minor and include: (1) clarification regarding recordkeeping and FDA review of records, (2) clarification regarding how a facility can meet the definition of a “very small business,” (3) addition of new examples of calculations, and (4) explanation of a simpler method for determining whether a facility’s 3-year average of food sales and food market value is below the inflation adjusted threshold for a “very small business.”
  • The dates for submitting an attestation to FDA have not changed.  Facilities subject to the PC Human Food rule must submit their first attestation to FDA by December 17, 2018, if they began manufacturing, processing, packing, or holding food before September 17, 2018.  Facilities subject to the PC Animal Food rule must submit their first attestation by December 16, 2019, if they began manufacturing, processing, packing, or holding animal food before September 17, 2019.  Beginning in 2020, attestation forms will need to be submitted during the food facility biennial registration renewal period that begins on October 1 and ends on December 31.

 

Court Rules on Preliminary Motions in NGO Suit on GRAS Rule

  • 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 because the safety of additives in food must be reviewed by FDA unless the additive is GRAS.
  • On May 22, 2017, a group of nonprofit organizations (the Center for Food Safety (CFS), Breast Cancer Prevention Partners (CPP), Center for Science in the Public Interest (CPI), Environmental Defense Fund (EDF), and Environmental Working Group (EWG)) sued FDA seeking a declaratory judgement that the GRAS Rule: “(1) violates fundamental principles of separation of powers, (2) exceeds FDA’s statutory authority, (3) does not accord with the law, (4) is arbitrary and capricious, and (5) is an abuse of discretion” and they are seeking vacation of the rule and that FDA reissue a rule consistent with the law.
  • FDA made a motion to dismiss the suit on the basis that the organizations lack standing to sue.  The Court filed its opinion on September 12, 2018 holding that CFS and EDF do have standing to sue and it dismissed the case, without prejudice, as to the other plaintiffs.  The case will proceed to discovery and the dismissed plaintiffs will have the option to reformulate their complaint and refile with the Court.  Thus, it is possible that the Court will eventually rule on the substantive issues raised by the plaintiffs as discussed above.
  • Keller and Heckman will continue to monitor the case. Given the current procedural posture of the lawsuit, we believe that industry should look for opportunities to file amicus briefs in support of the GRAS regulation and potentially meet with FDA Commissioner Gottlieb to emphasize the importance of GRAS and to encourage the Agency to vigorously defend the lawsuit.

FDA Announces Increased Enforcement to Curb Youth E-Cigarette Use

  • 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 companies, to minors.  Nearly all of those retailers cited appear to be convenience and similar stores, rather that vape shops dedicated to vapor products.   However, twelve warning letters were also issued to retailers that continue to offer several e-liquid products that were the subject of FDA enforcement in May 2018, based on their resemblance of kid-friendly foods (e.g., candy, cookies, juice boxes, etc.).
  • FDA Commissioner Scott Gottlieb stated in the press release that the agency will “revisit our compliance policy that extended the dates for manufacturers of certain flavored e-cigarettes to submit applications for premarket authorization” and that the agency remains concerned that “certain flavors are one of the principal drivers of the youth appeal of these products.”  FDA’s announcement comes just a few weeks after the comment period closed on its Advance Notice of Proposed Rulemaking on the Regulation of Flavors in Tobacco Products.
  • FDA is increasing its enforcement on illegal sales to minors “indefinitely” in an effort to reduce the current use of e-cigarettes in middle and high schoolers, which was 2.1 million users as of 2017.  Of note, U.S. cigarette smoking rates have continued to fall dramatically, alleviating fears of a potential “gateway” effect from vaping, and is now at its lowest point in history, amongst both adults and adolescents. FDA Commissioner Gottlieb did note that “the biggest youth use seems to be among cartridge-based e-cigarettes, and not open-tank vaping products.” For more on developments on e-liquids and related products, please visit our companion blog, the Continuum of Risk.

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

  • 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 advised consumers to avoid kratom or its psychoactive compounds, mitragynine and 7-hydroxymitragynine, in any form and from any manufacturer. FDA notes that they are not alone in their concern about the opioids found in kratom, as it is already illegal or controlled in several other countries including Australia, Denmark, Germany, Malaysia and Thailand. The substance is also banned in a number of states and municipalities in the U.S.
  • Kratom has been sold as dietary supplements (e.g., teas, powders, capsules) that are marketed to relieve opium withdrawals and to treat ailments including diarrhea, depression, diabetes, obesity, high blood pressure, stomach parasites, diverticulitis, anxiety, and alcoholism, among others. However, according to FDA, there have been no adequate and well-controlled scientific studies involving the use of kratom as a treatment for opioid use withdrawal or other diseases in human. Nor have there been studies on how kratom, when combined with other substances, may impact the body, its dangers, potential side effects, or interactions with other drugs. Thus, marketers are selling kratom with unsubstantiated claims. Selling unapproved kratom products with claims that they can treat opioid withdrawal and addiction and other serious medical conditions is a violation of federal law.
  • On September 4, 2018, FDA issued warning letters to two companies, Chillin Mix Kratom and Mitra Distributing, for marketing kratom products with scientifically unsubstantiated claims. In the letters, FDA states that the claims made establish that the kratom products are drugs as defined by section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Even more, FDA stated that the kratom products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), new drugs may not be introduced or delivered for introduction into interstate commerce without prior approval from FDA.
  • These warning letters are the latest action in FDA’s regulation and enforcement of kratom manufacturers and marketers. In May of 2018, FDA announced it had issued warning letters to three companies marketing kratom products with medical claims, similar to the claims presently at issue. Additionally, on April 2, 2018, FDA issued its first ever mandatory recall order for all products containing powdered kratom manufactured, processed, packed, or held by Triangle Pharmanaturals LLC, after several tested positive for salmonella.
  • In light of the current opioid epidemic in the United States, FDA states they will continue to urge consumers not to consume kratom and to seek appropriate medical care from their health care provider, as well as take action against those who put the safety of American consumers at risk.

USDA and FDA Announce Joint Meeting on Animal Cell Culture Technology

  • 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 then, there has been some debate as to whether FDA or USDA should have jurisdiction over cultured meat.
  • The jointly sponsored October meeting will cover the potential hazards that need to be controlled for the safe production of animal cell cultured food products and oversight considerations by regulatory agencies on the first day. The second day of the meeting will focus on labeling considerations.
  • Representatives from industry, consumer groups and other stakeholders are invited to participate in the meeting. Pre-registration is encouraged and can be done through the Meetings and Events page on USDA’s Food Safety and Inspection Service’s (FSIS) website. The comments that were submitted to FDA in regards to the July 12, 2018 public meeting, in addition to new comments, will be considered.
  • In a press release about the October meeting, both FDA Commissioner Scott Gottlieb and USDA Secretary Sonny Perdue indicated the need for future cooperation between the two agencies with regards to regulating cultured meat products.
    • “Recent advances in animal cell cultured food products present many important and timely technical and regulatory considerations for the FDA and our partners at USDA,” stated FDA Commissioner Scott Gottlieb in the release.
    • “American farmers and ranchers feed the world, but as technology advances, we must consider how to inspect and regulate to ensure food safety, regardless of the production method,” said USDA Secretary Sonny Perdue.
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