• The U.S. Food and Drug Administration (FDA) discusses how the Agency is integrating new tools, that are a result of the passage of the Food Safety Modernization Act (FSMA),  with existing ones to improve the safety of imported foods in a newly released publication, “Strategy for the Safety of Imported Food.” (For background information on these new tools, see our previous blogs on the Foreign Supplier Verification Program (FSVP), the Accredited Third-Party Certification program’ and the Voluntary Qualified Importer Program (VQIP).)
  • Noting that the U.S. imports about 15% of its overall food supply from more than 200 countries or territories, FDA explained that the volume and variety of imported food and the complexity of global supply chains make food safety a challenging issue to address. Below is a brief summary of the goals that FDA has outlined in the Strategy document.
  • Goal 1 – Food Offered for Import Meets U.S. Food Safety Requirements. This involves optimizing the use of foreign inspection, effective implementation of the FSVP, use of reliable third-party audits and the VQIP. In addition, FDA will collaborate with foreign governments, standards development organizations, and others. For example, FDA has made system recognition arrangements with New Zealand, Canada, and Australia and is working with the European Union on a mutual assessment.
  • Goal 2 – FDA Border Surveillance Prevents Entry of Unsafe Foods. FDA’s surveillance of imported food at more than 300 active U.S. ports of entry generally involves screening, examination, sampling, and testing. The Agency plans on incorporating new sources of information into import screening and expanding testing methods. Additionally, FDA will collaborate with state and other regulatory authorities; use import alerts; and require import certification as a condition of admission, where appropriate.
  • Goal 3 – Rapid and Effective Response to Unsafe Imported Food. While FSMA granted FDA mandatory recall authority, voluntary recalls are still the primary means to remove “violative products” from the U.S. food supply. Reaching this goal will also involve gaining greater access to information from foreign sources and maximizing effectiveness of response to an event involving imported food. FDA also plans to further develop and refine processes to enable use of Agency authorities to prevent importation of unsafe food from facilities, including those with suspended registrations.
  • Goal 4 – Effective and Efficient Food Import Program. FDA will develop an improved global inventory of food facilities and farms to optimize resource allocation for imported food safety oversight to areas of higher risk.
  • In a statement on FDA’s new strategy to advance oversight of imported food, FDA Commissioner Scott Gottlieb, M.D., and Deputy Commissioner Frank Yiannas concluded, “Overall, our modern strategy is designed to leverage our different authorities and tools to provide a multi-layered, data-driven, smarter approach to imported food safety.”

 

  • As reported here, the domestic and import inspection program for Siluriformes fish and fish products (including catfish) was transferred from FDA to USDA in response to a congressional mandate.  After September 1, 2017, only foreign countries that had submitted documentation showing the equivalence of their Siluriformes fish inspection system with that of the U.S. could continue exporting these products to the U.S.  Additionally, as of August 2, 2017, all shipments of imported Siluriformes entering the U.S. must be presented at an Official Import Inspection Establishment for re-inspection by USDA Food Safety and Inspection Service (FSIS) personnel.
  • FSIS routinely monitors distributors and cold storage facilities for “failure to present violations.”  Recent recalls suggest that enforcing the re-inspection requirement of the Siluriformes fish inspection system is an important priority for FSIS.  See Fulton Seafood (February 22, 2019), TV Food (February 22, 2019), Richwell Group (February 5, 2019), American Best (February 4, 2019), H&T Seafood (January 18, 2019) and Mannarich Food (December 15, 2018).
  • The recall classification for products that are violative on account of not being presented for FSIS re-inspection as required is Class I ( i.e., “involves a health hazard situation in which there is a reasonable probability that eating the food will cause health problems or death”).  Further, FSIS routinely issues health alerts for such products although they have not typically been associated with other actionable defects or reports of adverse reactions due to consumption.

 

  • House Bill 1204 and Senate Bill 5397 would prohibit producers that do not participate in a plastic packaging stewardship organization from selling packaging made wholly or in part from plastic in Washington State, beginning in 2022. Plastic food service products, including utensils, and other specified plastic items associated with food or beverage service are included in the definition of plastic packaging. A “producer of plastic packaging” is defined as a person that meets one of these criteria:
  1. Has legal ownership of the brand to which plastic packaging is applied;
  2. Is the first importer into Washington state of a product to which plastic packaging is applied;
  3. Sells at retail a product, to which plastic packaging has been applied; or
  4. Otherwise elects to assume compliance responsibility for a product.
  • The legislation specifies that the stewardship organization must submit a plan to the Washington State Department of Ecology and that plan must be approved by the department. The legislation provides details on what must be included in the plan, such as a description of the plastic packaging categories covered by the program, an analysis of plastic packaging litter found in public places, a funding mechanism for the program, and a description for plastic packaging collection. With respect to food packaging, a comprehensive analysis of the overall amount of packaging in the recycling waste stream containing more than de minimis food residue or food waste is required.
  • The Washington Senate Environment, Energy and Technology Committee has passed the senate version of the bill and it is now before the Senate Ways & Means Committee, which has scheduled a hearing on the bill for February 25. The House Bill is before the Committee on Environment and Energy. Plastics Recycling Update points out that while extended producer responsibility (EPR) programs for packaging have not been implemented in any U.S. state, they have taken effect throughout Canada and in parts of Europe.
  • Following on recalls of dog food due to excess Vitamin D in late 2018, manufacturers are facing lawsuits by dog owners claiming their pets were injured by the products in question.
  • According to FDA, analysis of the recalled dog foods by state and private labs indicate that the dog food contained as much as 70 times the intended amount of vitamin D, and all eight brands that were subject to the recall had been produced by the same contract manufacturer.
  • In one class action suit, filed against Hill’s Pet Nutrition in the Eastern District of New York, plaintiffs are claiming that the company delayed warning consumers.  Specifically, the suit claims that consumer complaints started in February 2018, 11 months prior to the company recalling its products in late January 2019.  Similar suits have been filed in Florida and California, and there may be more to come.
  • As reported on this blog, on February 13, 2019, FDA released findings from the Agency’s investigation of the November 2018 outbreak of E. coli O157:H7 infections involving romaine lettuce. Those findings concluded that water from on-farm water reservoir, which was likely not effectively sanitized, most likely led to contamination of some of the romaine lettuce. In a statement from FDA Commissioner Scott Gottlieb and Deputy Commissioner Frank Yiannas, the leaders noted that moving forward, “[o]ur first goal is working with federal, state and industry partners on implementing best practices to try and prevent these outbreaks in the first place.”
  • The recent romaine lettuce outbreaks in 2018 occurred after FDA sought to extend the compliance dates for the agricultural water requirements of the Produce Safety Rule by an additional two to four years (for produce other than sprouts) in a September 2017 Proposed Rule. (82 FR 42963). The new agricultural water compliance date the FDA is proposing for the largest farms is January 26, 2022. Small farms and very small farms would have until January 26, 2023 and January 26, 2024, respectively.
  • Chair of the Congressional Food Safety Caucus, Congresswoman Rosa DeLauro condemned FDA’s delay of the Produce Safety Rule in light of the report on the romaine lettuce recall. “The FDA’s investigations into last year’s romaine lettuce recalls have confirmed what we already knew to be true: dirty irrigation water contaminates produce and makes people sick…Eight years after the Food Safety Modernization Act was signed into law, it is long past time these important rules went into effect—not delayed into the next decade.” FDA has yet to finalize its proposed extension of the Produce Safety Rule’s agricultural water requirements.
  • On February 15, 2019, the United States Department of Agriculture’s (USDA) published a proposed rule to amend the National List of Allowed and Prohibited Substances (the “National List”) for crops and handling based on April 2018 recommendations from the National Organic Standards Board (NOSB). See 84 FR 4377. The National List, codified at 7 CFR 205.601 through 205.606, identifies synthetic substances that may be used and natural substances that may not be used in organic crop and livestock production as well as a limited number of non-organic substances that may be used in or on organic processed products. Under the authority of the Organic Foods Production Act of 1990, the National List can be amended by the Secretary based on recommendations developed by the NOSB.
  • USDA’s proposed rule would amend the National List to implement three NOSB recommendations, submitted to the Secretary on April 27, 2018. The proposed changes would allow:
    • Elemental sulfur to be used as a slug or snail bait to reduce crop losses.
    • Polyoxin D zinc salt to control fungal diseases when other organic fungicides have been found to be less effective.
    • Magnesium chloride to be reclassified from a synthetic to a non-synthetic substance, requiring handlers to ensure that the product complies with the non-synthetic classification by obtaining details about the source of the magnesium chloride and its full manufacturing process.
  • The comment period for the proposed rule ends on April 16, 2019.
  • As previously reported on this blog, in November 2018 FDA, in conjunction with the CDC, state officials, and Canadian food and public health officials, investigated an outbreak of E. coli O157:H7 infections in multiple US states and Canadian provinces. The investigation determined the cause of the outbreak was the consumption of contaminated romaine lettuce. Indeed, thirty (83%) of 36 ill consumers interviewed reported eating romaine lettuce the week before illness onset. All E. coli O157:H7 isolates from ill consumers had a rare genetic fingerprint, as determined by whole genome sequencing (WGS), that was closely related to one previously seen in ill consumers in the fall of 2016 and the fall of 2017. The November 2018 outbreak was declared over in the US on January 9, 2019.
  • On February 13, 2019, FDA released the findings from the Agency’s investigation of the November 2018 outbreak. With the help of WGS, investigators were able to narrow down the growing location of the romaine lettuce to specific California counties. The traceback investigation further identified multiple farms that may have been the cause of the outbreak.
  • In their report, FDA identified factors that most likely contributed to the contamination of romaine lettuce, specifically from one farm in Santa Maria in Santa Barbara County, California. Those factors include the following:
    • The outbreak strain of E. coli O157:H7 was found in the sediment of an on-farm water reservoir in Santa Maria.
    • The outbreak strain was not found anywhere else in sampling done during the investigation in various California leafy greens growing areas and counties.
    • The water from the on-farm water reservoir most likely led to contamination of some of the romaine lettuce. The water was likely not effectively sanitized. The water may have come in contact with the romaine through multiple avenues, including direct harvest/postharvest application and/or use of water on harvest equipment.
    • FDA is not sure how the water became contaminated.
    • Other ranches owned by the same farm, as well as other farms, may have sold contaminated lettuce.
    • Due to the fact that the same specific strain of E. coli O157:H7 occurred in 2016 and 2017, it may be likely that the strain remained in the environment or repeatedly introduced from an unknown source.
  • Based on these findings, FDA provided recommendations for the prevention of future outbreaks. Such recommendations include adhering to the recommendations of the Environmental Assessment associated with the spring 2018 STEC outbreak, FSMAs Produce Safety Rule, and FSMAs Preventive Controls for Human Foods Rule. And specifically for growers of leafy greens, FDA recommends assessing the growing operations, assuring all agricultural water is safe and of adequate sanitary quality, and performing a root cause analysis when a foodborne pathogen is identified.
  • The findings provide hope that growers and public health officials will be able to prevent or mitigate potential future outbreaks.

The full FDA report can be accessed here.

  • FDA has issued warning letters and online advisories to a number of dietary supplement companies whose products claim to prevent, treat, or cure Alzheimer’s disease and other serious conditions.  The disease claims cause the supplements to be considered unapproved new drugs that violate the Federal Food, Drug, and Cosmetic Act.
  • The products in question include tablets, capsules, and oils containing ingredients such as avocado oil, green tea extract, omega-3 fatty acids, black cumin seed oil, and coconut oil.  In addition to making Alzheimer’s disease claims, the products also claim to treat conditions such as the flu, high blood pressure, parasites, asthma, and diabetes.
  • In a related press release, FDA noted that these products pose a risk to the public because they “may be ineffective, unsafe and could prevent a person from seeking an appropriate diagnosis and treatment.”  Given that FDA Commissioner Scott Gottlieb has launched an initiative to improve the safety of dietary supplements, including more rapidly communicating with the public about potential safety issues, we can expect to see more of these press releases and enforcement actions in the future.
  • A New York federal court ordered a consumer class action against KIND LLC to move forward after a two-year stay. Consumers are suing KIND for allegedly mislabeling its snack products as both “non-GMO” and “all natural,” even though the products purportedly contain synthetic and genetically modified ingredients.  On September 15, 2016, U.S. District Judge William H. Pauley III stayed the “all natural” claims pending possible new FDA guidelines on use of the term.  At the time of the stay, the court stated that it would “reconsider the appropriateness of continuing the stay as the FDA’s process unfolds.” The “non-GMO” claims were stayed in 2018 to avoid splitting the two issues apart.
  • As a reminder, in November 2015, the FDA published a Request for Information and Comments regarding the use of the term “natural” in the labeling of food products, including foods that are genetically engineered or contain ingredients produced with genetic engineering. See 80 FR 69905 (Nov. 15, 2015). Although the comment period closed in May 2016, FDA has not taken any further action on this matter.
  • In 2018, Judge Pauley denied both KIND’s motion to dismiss and the consumers’ request to lift the stay on their “all natural” claims. The stay was to be in effect, and subsequently reconsidered, until August 15, 2018. However, six months have now passed since the court deadline, and thus Judge Pauley decided to lift the stay. Judge Pauley stated that there is “no indication whether the FDA is earnestly working toward a uniform ‘natural’ standard, or whether it has shelved that effort. […] As such, this court explained that it ‘cannot sit idly by on an illusory assurance that something is likely to happen.’”
  • As we’ve previously posted on this blog, “natural” and “all natural” lawsuits have been the focus of much litigation in recent years. And as this court order indicates, such suits do not appear to be slowing down.
  • On February 11, FDA Commissioner Scott Gottlieb, M.D. announced a new plan for modernizing and strengthening dietary supplement regulation and oversight. In making the announcement, Dr. Gottlieb pointed out that supplement use is increasing with three out of every four American consumers taking a dietary supplement on a regular basis. Also, since Congress passed the Dietary Supplement Health and Education Act (DSHEA) 25 years ago, the dietary supplement market has grown significantly—from a $4 billion industry to an industry worth more than $40 billion.
  • “As the popularity of supplements has grown, so have the number of entities marketing potentially dangerous products or making unproven or misleading claims about the health benefits they may deliver,” Dr. Gottlieb explained, adding that the new plan has the goal of implementing one of the most significant modernizations of dietary supplement regulation and oversight in more than 25 years.  Under the plan, FDA will implement the five steps described below.
  1. Develop new ways to communicate more quickly when FDA is concerned that an ingredient is unlawful and potentially dangerous and should not be marketed in dietary supplements. This will involve a new rapid-response tool.
  2. Ensure that the regulatory framework for dietary supplements is flexible enough to adequately evaluate product safety while promoting innovation. The guidance that FDA is developing for preparing new dietary ingredient (NDI) notifications is part of this effort. “An effective NDI notification process represents the FDA’s only opportunity to evaluate the safety of a new ingredient before it becomes available to consumers and helps promote transparency and risk-based allocation of resources,” Gottlieb explained. (See our blog on FDA’s NDI Draft Guidance for background information.)
  3. Undertake more collaborative research with industry, such as the recently created the Botanical Safety Consortium, a public-private partnership to promote scientific advances in evaluating the safety of botanical ingredients and mixtures in dietary supplements. This group will look at novel ways to use cutting-edge toxicology tools, including alternatives to animal testing.
  4. Continue to take actions to protect public health and develop new enforcement strategies. (On February 11, FDA sent 12 warning letters and five online advisory letters to companies  whose products, many of which are marketed as dietary supplements, are being illegally marketed as unapproved new drugs.)
  5. Establish public dialog on whether additional steps are necessary to modernize DSHEA. These steps could include amending the statute to establish avenues for dietary supplement exclusivity and a mandatory listing requirement to improve transparency, possibly help facilitate efficient enforcement of the law, and establish new mechanisms to identify bad actors.
  • In the coming months, FDA will provide addition details on steps it is taking to modernized dietary supplement regulation, Dr. Gottlieb added.