FDA Commissioner Gottlieb Issues Statement On Advancing the Science and Regulation of Live Microbiome-Based Products

  • 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 effects reported from the use of probiotics for this disease, noting that data collected on the impact of probiotics are hard to interpret because there is a lack of systemization in the studies.  He also noted that different probiotic preparations have been studied or other interventions have been administered in conjunction with the probiotics.  He concluded by stating that the key is determining when the benefit of probiotics outweighs the potential risks, warning that FDA will consider taking action when it sees unsafe or violative products.
  • FDA has not approved any probiotic as a live biotherapeutic product – a biological product other than a vaccine that uses live organisms – as a drug.  However, there currently are probiotic-containing foods, including dietary supplements, on the market.  Foods with probiotics may not be legally marketed to cure, mitigate, treat, or prevent any disease.
  • FDA is convening a workshop on September 17 to discuss the “clinical, manufacturing, and regulatory considerations associated with microbiome-based products.”  FDA has also issued a guidance document regarding the manufacturing requirements for microorganisms to be used in drug clinical trials.

FDA Releases Q&A for Preventive Controls for Animal Foods

  • 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 Good Manufacturing Practice (CGMP) rules for animal food because there had not been longstanding CGMPs for the animal food industry.  FDA wanted to give industry time to focus solely on the foundation of CGMPs before imposing more onerous HARPC requirements.  FDA states that it will not conduct regulatory inspections for small businesses to evaluate compliance with HARPC requirements until the fall of 2019 in light of industry feedback that more time and technical assistance is needed to comply.
  • Of course, FDA will conduct inspections of small businesses “for-cause” before the fall of 2019 if, for example, a facility has a history of violative product or environmental samples, there is a recall, there are significant observations made during a previous inspection, or the facility is the subject of FDA or state enforcement action.  FDA’s delay of routine inspections should not be seen as a delay in the HARPC compliance date for small businesses, which remains September 17, 2018.

FDA Explains What to Expect As Compliance Date Nears for PC Animal Food Rule

  • 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 with fewer than 500 such employees.
  • The compliance dates for the Preventive Controls (PC) and Current Good Manufacturing Practice (CGMP) requirements are staggered for animal food companies. FDA believed a year to solely focus on CGMPs would provide a helpful foundation prior to implementing preventive controls. Large and small facilities previously had to meet the CGMP requirements by September 2016 and September 2017, respectively. Also on September 17, 2018, facilities that are very small animal food businesses will be required to comply with the CGMPs. Very small businesses are those averaging less than $2.5 million per year in sales plus the market value of animal food they make or hold. These facilities are exempt from the full preventive controls requirements, but they have an additional year to meet the requirements applicable to qualified facilities.
  • FDA also published a conversation with consumer safety officer Jenny Murphy from FDA’s Center for Veterinary Medicine. In the conversation, Ms. Murphy explains what animal food producers can anticipate in this phase of implementation of the rule. 2018 will be the first year in which all three business sizes (large, small, and very small) have reached at least one of their compliance dates. 2018 will also be the first year in which FDA will begin routine regulatory inspections to ensure compliance with the preventive controls requirements. Additionally, Ms. Murphy discusses the available resources to assist industry with implementing the regulations, as well as how the final rule applies to producers of human food who supply by-products for use as animal food. Lastly, Ms. Murphy emphasized that FDA is currently focused on educating food producers to ensure the proper development, implementation, and fine tuning of their preventive controls and current good manufacturing practice requirements.

USDA Files New Bioengineered Food Symbols with U.S. Patent and Trademark Office

  • 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 requested comment, in part, on whether the word  “Bioengineered” should be incorporated into the design of the chosen symbol and whether the phrase “May be” should be incorporated into the design of the chosen symbols to account for “may” disclosures.

  • On August 7, 2018, USDA filed six new bioengineered food symbols with the U.S. Patent and Trademark Office, to “certify that a product…is a bioengineered food”:

  • Interestingly, two of the newly filed symbols include the text, “made with bioengineering,” which was not explicitly contemplated in the proposed rule. Further, the new filing do not utilize the “smiley faces” associated with proposed Alternatives 2-B and 2-C, which received much attention in the comments to the proposed rule. Whether USDA adopts any of the newly filed symbols remains to be seen, but nevertheless, the filings do serve as a signal of USDA’s thinking as the Department works to finalize the regulations to implement the NBFDS.

Monsanto Will Appeal Order to pay $289 Million to a Man Whose Cancer a Jury Found was Caused by Occupational Exposure to Roundup Weed Killer

•       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 stated that it will appeal the verdict.
•       Mr. Johnson’s was the first tried of thousands of cases filed by cancer patients or their estates against Monsanto following a March 20, 2015 report by the International Agency for Research on Cancer (IARC) finding glyphosate – the active ingredient in Roundup – is “probably carcinogenic to humans.”  Most other scientific bodies, however, including the U.S. Environmental Protection Agency (EPA) have found that glyphosate is not likely to be carcinogenic to humans.
•       Regarding potential exposure to glyphosate from food, the Food and Drug Administration (FDA) has reported on preliminary results for glyphosate testing that showed no pesticide residue in excess of the EPA tolerances for glyphosate in all four commodities tested (soybeans, corn, milk, and eggs).  New outlets reported in May 2018, however, on internal FDA emails concerning detection of glyphosate at violative levels in unofficial samples of crackers, granola, cornmeal, honey, oatmeal, baby food, and corn (not a designated sample) that were analyzed outside of the planned study.  Official FDA testing for glyphosate in an expanded range of foods began this fiscal year.
•       The California state court verdict against Monsanto for this plaintiff indicates that EPA’s safety conclusion for glyphosate exposure may not be an insurmountable obstacle to other juries potentially finding that Roundup caused or contributed to thousands of other plaintiffs’ cancers.

Former Director of the FDA’s Office of Biotechnology Pens Op-Ed Criticizing FDA Enforcement on Organic Labeling, FDA Commissioner Pledges to Look at Labeling Claims in Organics

  • 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 can contain numerous synthetic as well as natural chemicals.  The op-ed also highlights the author’s inability to find a single FDA warning letter or other enforcement action against “non-GMO” claims, where the products have no GMO counterpart or couldn’t possibly contain GMOs.  Ultimately, the author concludes that “consumers need aggressive FDA action to curb these abuses and level the playing field.”

 

  • Two days after the op-ed was published, FDA Commissioner Scott Gottlieb tweeted a pledge to look into the terms used in food packaging, “in coming weeks, I’m going to put out more detailed information on what different terms mean on food packaging, to help consumers best use claims like organic, antibiotic free, etc.” The Commissioner also highlighted the distinct roles FDA and USDA have when it comes to oversight of organic foods. While USDA is charged with regulating use of the term “organic” on food labels through its oversight of the National Organic Program, FDA “oversees general food labeling compliance and safety issues.” Stay tuned for more from FDA on this.

 

  • As for non-GMO claims, this blog has been closely following USDA’s proposed rule for the National Bioengineered Food Disclosure Standard, which proposes to allow food certified under the National Organic Program to make claims regarding the absence of bioengineering in food. How the final rule squares with FDA’s current labeling guidance on foods derived from genetically engineered plants (which states, in part, that a statement claiming absence of genetically engineered ingredients may be false or misleading where there is no GMO counterpart to some of the ingredients) remains to be seen.

Is Pet Food the Next Front for “Natural” Lawsuits?

  • 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 (e.g., granola bars, cereal, green tea, oatmeal, honey) have been the subject of lawsuits challenging natural claims based on glyphosate residues, other consumer products have not faced as many challenges for natural claims.  The lawsuit against Nutrish could be a harbinger of more challenges for “natural” claims in the pet food sector, where such claims have proliferated in recent years.

FDA Believes Concentrated Animal Feeding Operation May Be A Cause of Romaine Outbreak

  • 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 samples of canal water in Yuma tested positive for the outbreak strain of E. coli, and that the contaminated water coming into contact with the produce was a viable explanation for the cause of the outbreak. FDA also discussed that the location of the canal is situated close to a Concentrated Animal Feeding Operation (CAFO) and can hold in excess of 100,000 head of cattle at any one time, and that FDA traceback information showed a clustering of romaine lettuce farms nearby.
  • According to foodsafetynews.com, the Task Force suggested tripling the industry-imposed 400-foot buffer zone to separate leafy greens growing fields from animal feedlots. Members of the California and Arizona Leafy Greens Marketing Agreement are accepting comments on the setback suggestion before making a final decision on required buffer zone size. This suggestion demonstrates the produce industry’s interest to have preventive measures in place before the next growing season.
  • On August 6, the FDA publicly released a statement about the CAFO hypothesis, and added that their experts are continuing to work on examining potential links between the CAFO, adjacent water, and geologic and others facts that may explain the contamination and its relationship to the outbreak. FDA will detail its findings in an environmental assessment report, though the exact release date of the report was not given.
  • As our readers may remember, we’ve previously discussed the outbreak, which was declared officially over on June 28. As a result of the outbreak, five people died and more than 200 others across 36 states were confirmed with infections.

NGOs Sue USDA Over Delay in Issuing BE Disclosure Rules

  • 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 USDA are named as plaintiffs in the suit. The nongovernment organizations (NGOs) filed the lawsuit in order to obtain a mandated schedule of when the implementing rules will be published, CFS stated in a press release.
  • This is not the first time CFS has sued USDA in connection with the NBFDS. The Center sued USDA in September 2017 for not releasing the results of a study on possible technical challenges to obtaining BE information through electronic or digital disclosure methods that was mandated by the Act. CFS dropped that lawsuit after USDA released the study results (See our Dec. 1, 2017 blog for more details). Last month, CFS sued USDA for denying its Freedom of Information request (FOIA) to obtain documents surrounding the Department’s decision on how to label BE foods. More information on that suit can be found on CFS’s website.
  • The comment period on USDA’s proposed requirements to implement the NBFDS closed on July 3. (See our July 6 blog to view a summary of the comments received.) We will continue to monitor developments on the NBFDS.

Recent Federal Charges Over Mislabeled Chesapeake Blue Crab Highlight Inability of the Seafood Import Monitoring Program to Combat Fraud Perpetrated in the United States

  • Blue crab is among several species known to be susceptible to illegal, unreported, and unregulated (IUU) fishing and seafood fraud.  As reported on this blog, the National Oceanic and Atmospheric Administration’s (NOAA) has established a Seafood Import Monitoring Program (SIMP) with regulations that took effect January 1, 2018, requiring importers to document that the catch is legally and sustainably caught.  SIMP was implemented in response to longstanding concerns over rampant seafood fraud.
  • A recent article in the Washington Post, An unsavory scam? Company accused of diluting Chesapeake blue crab meat with imported crab, illustrates the limitations of SIMP in preventing seafood fraud perpetrated in the United States.  According to the article, federal prosecutors have alleged that between 2012 and 2015, Casey’s Seafood Processing sold over 398,000 pounds of crab meat labeled as Chesapeake blue crab from the United States, but intentionally mixed in cheaper species of crab from foreign countries that were not identified on the label.  This economic adulteration was uncovered in a search of the Newport News, VA seafood processing facility after a tip from an informant that Casey’s Seafood Processing was attempting to undercut market prices for the scarce and highly regulated Chesapeake blue crabs.  The dilution of the Chesapeake blue crab meat with other species was verified using DNA analysis of the mislabeled crab meat.
  • The species used to perpetrate this instance of Chesapeake blue crab meat labeling fraud were not subject to SIMP.  Moreover, SIMP has no provision that would reach the actions of plants such as Casey’s Seafood Processing operating in the U.S. even if the Chesapeake blue crab meat had been diluted with crab meat covered under SIMP.  Charges in the case were brought against the plant’s owner, James R. Casey, under the Lacey Act, a federal law from 1900 that, among other things, prohibits selling wildlife such as crab meat that is mislabeled under the Federal, Food, Drug and Cosmetic Act.
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