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  • As our readers may recall, on November 25, FDA issued warning letters to 15 companies for illegally selling FDA-regulated products containing cannabidiol (CBD) in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). FDA alleged that CBD lacks an appropriate regulatory status in the products and, in some cases along with product claims, causes them to be marketed unlawfully.
  • One of the warning letters was sent to Infinite Product Company LLLP DBA Infinite CBD, in which FDA alleged Infinite was marketing unapproved drugs containing CBD. The FDA cited claims on the company’s website that CBD could alleviate symptoms of autism and can treat diseases like hepatitis, cancer, and Tourette’s syndrome.
  • On November 27, plaintiff Adam DaSilva filed suit against Infinite Product Co alleging the company sells food, supplement and cosmetic products that are unapproved new drugs in violation of federal law. DaSilva said in the proposed class action suit that Infinite Product’s CBD products are misleadingly labeled and are illegal to sell. In the complaint, DaSilva pointed to the FDA’s recent warning letter to Infinite Products, detailing numerous violations regarding its products, including skin creams and gummies. According to the complaint, there are “[m]any unanswered questions and data gaps about CBD toxicity exist, and some of the available data raise serious concerns about potential harm from CBD.” Indeed, DaSilva noted that, in a revised Consumer Update, FDA stated that it “is not aware of any basis to conclude that CBD is [generally recognized as safe (GRAS)] for use in conventional [human or animal] food.”
  • The lawsuit appears to be one of the first private actions filed as a result of FDA’s recent warning letters that allege the use of CBD runs afoul of federal regulations. We will continue to monitor this case as well as other CBD-related lawsuits and regulatory actions.
  • As our readers know, this blog has previously covered the romaine lettuce E. coli outbreaks that occurred in the spring and fall of 2018. Ultimately, FDA determined that the outbreak that occurred in the spring of 2018 may have been caused by Concentrated Animal Feeding Operations (CAFOs) in the Yuma, Arizona area, and the outbreak that occurred in the fall of 2018 may have been due to a contaminated on-farm water reservoir.
  • On November 19, U.S. Senator Kirsten Gillibrand, D-NY announced her new legislation to help improve food safety across the country. The Expanded Food Safety Inspection Act would expand FDA’s investigative authorities to trace the source of outbreaks of foodborne illness. Under existing law and regulations, FDA is limited to investigating the produce farms from where the outbreaks originated. However, FDA does not have the ability to access nearby farms that may be the source of contamination or that may have contributed to the root cause of a foodborne illness outbreak. As explained in a press release, the Expanded Food Safety Inspection Act would allow the FDA to coordinate with state and local public health organizations, the USDA, and the CDC in order “to better determine the source of outbreaks and give them the authority to investigate contamination from nearby farms.” This would help eliminate sources of contamination directly, decrease the chances of repeated outbreaks within the same region, and facilitate the quick recall of dangerous food products.
  • Senator Gillibrand is to introduce the bill in the Senate within the coming weeks. The legislation is endorsed by the Center for Science in the Public Interest and the Consumer Federation of America. We will continue to monitor developments on the Expanded Food Safety Inspection Act

The Daily Intake is taking a break for the Thanksgiving holiday and will return on December 2, 2019.  We wish you a wonderful Thanksgiving holiday! 

  • On November 7, the Plant Based Foods Association (PBFA) and Upton’s Naturals dropped their federal lawsuit challenging Mississippi’s legislation that banned plant-based foods sold in Mississippi from using meat-related terms on labels, after Mississippi proposed new regulations. As our readers may recall, in early September, the Mississippi Department of Agriculture and Commerce proposed new regulations to implement the law that would allow the use of meat-related terms on the labels of plant-based food if one or more of the following terms, or a comparable qualifier, is prominently displayed on the front of the package: “meat free,” “meatless,” “plant-based,” “veggie-based,” “made from plants,” “vegetarian,” or “vegan.” PBFA and Upton’s dropped the lawsuit on the same day the revised labeling regulations took effect.
  • PBFA and Upton’s lead attorney, Justin Pearson of the Institute for Justice, called the outcome a “total victory” and stated that the PBFA and Upton’s “simply wanted to continue using clear labels with the terms consumers understand best. In response to our lawsuit, the Mississippi Department of Agriculture has done the right thing, so there is no need to move forward with the lawsuit.”
  • While the Mississippi lawsuit has been dropped, countless other state suits continue on. And at the federal level, plant-based products face a new potential labeling barrier. U.S. House of Representatives Anthony Brindisi (D-NY) and Roger Marshall (R-KS) introduced the Real Marketing Edible Artificials Truthfully (MEAT) Act of 2019 (H.R. 4881). The Real MEAT Act would amend the Federal Food, Drug, and Cosmetic Act to “ensure that consumers can make informed decisions in choosing between meat products such as beef and imitation meat products.” The Act states that “any imitation meat food product, beef, or beef product, shall be deemed to be misbranded unless its label bears, in type of uniform size and prominence, the word ‘imitation’ immediately before or after the name of the food and a statement that clearly indicates the product is not derived from or does not contain meat.” The bill alleges that imitation products create confusion in the marketplace. The Real MEAT Act was introduced on October 28, 2019 and has been referred to the House Committee on Energy and Commerce and the Committee on Agriculture. We will continue to report on any developments of the Real MEAT Act and other developments that impact the labeling of plant-based foods and meat products.
  • On November 1, President Trump announced his intent to nominate Dr. Stephen Hahn to be the new FDA Commissioner. Dr. Hahn is a radiation oncologist and currently serves as the Chief Medical Officer of MD Anderson Cancer Center in Houston, Texas. At MD Anderson, Hahn manages a $5.2 billion operating budget, 20,300 employees, 7,000 trainees and more than 3,000 volunteers. He has never served in a government post.
  • As our readers may recall, the change in FDA leadership stems from former FDA Commissioner Scott Gottlieb’s resignation in April. Gottlieb was confirmed as FDA Commissioner in May 2017 and drove several significant initiatives from food safety modernization to youth nicotine use. In April, Dr. Ned Sharpless replaced Gottlieb as Acting Commissioner of Food and Drugs. It had been assumed that Dr. Sharpless would remain the Acting Commissioner until Dr. Hahn was confirmed. However, due to the Federal Vacancies Reform Act, Dr. Sharpless’s term with the Agency expired on November 1. The Act requires that a person may not serve in an “Acting” capacity for longer than 210 days. Dr. Sharpless has since returned to his role as Director of the National Cancer Institute (NCI).
  • According to a press release from U.S. Secretary of Health and Human Services Alex Azar, Admiral Brett Giroir, Assistant Secretary for Health, will oversee the FDA, pending Dr. Hahn’s confirmation. In the press release, Secretary Azar stated that “Admiral Giroir has been an indispensable leader for HHS on a number of public health priorities. As Assistant Secretary for Health, whose authorities include overseeing the U.S. Public Health Service, he will be able to assume the delegable duties of the Commissioner at this time and ensure the FDA’s work continues to move forward.”
  • The FDA Food Safety Modernization Act (FSMA) directs FDA to establish a program for the testing of food by accredited laboratories.  Under this program, FDA must recognize accreditation organizations that accredit food testing laboratories and adopt model accreditation standards that such laboratories must meet.
  • On November 1, 2019, FDA released a proposed rule under which FDA will recognize accreditation bodies, which will, in turn, accredit laboratories to conduct food testing.  FDA’s proposed laboratory accreditation program partially incorporates two globally recognized and widely used voluntary consensus standards, ISO/IEC 17011:2017 and ISO/IEC 17025:2017, as foundational requirements for accreditation bodies and laboratories, respectively.  Once the laboratory accreditation program is established, testing of human and animal food in certain circumstances must be conducted by an accredited laboratory and the results must be sent directly to FDA.  A full test report is required unless the testing laboratory meets FDA’s proposed provisions for submitting an abridged report.  Circumstances where testing by an accredited laboratory would be required include:

 – To comply with specific FDA testing requirements applied to address an identified or suspected food safety problem (including certain tests of shell eggs, bottled water, and sprouts);

 – To provide evidence on the admissibility of imported food (e.g., for a food that has been detained due to an appearance of adulteration);

 – To support the removal of a food from an import alert through successful consecutive testing;

 – To address an identified or suspected food safety problem and provide evidence for an informal hearing before a mandatory recall order, as part of a corrective action plan submitted after an order suspending the registration of a food facility, or as part of evidence submitted for an appeal of an administrative detention order;

 – To respond to a “food testing order,” which is a new procedure proposed by this rule to address an identified or suspected food safety problem.

  • Laboratories run and operated by federal agencies, states, localities, and foreign government entities, as well as private laboratories, including in-house laboratories, will be eligible for accreditation under FDA’s proposed program.  Laboratories could be accredited in one or more major disciplines (e.g., microbiology, chemistry, and physical testing).  FDA will establish a publicly available list of recognized accreditation bodies and laboratories accredited.  Both accrediting bodies and accredited laboratories will be subject to FDA oversight, although accrediting bodies will have primary oversight of accredited laboratories.
  • Comments on FDA’s proposed rule are due by March 3, 2020.  The laboratory accreditation program would become effective 60 days after a final rule is published; however, FDA will allow itself an unspecified time period after that to get ready to accept applications for recognition from accrediting bodies.  Then it will take more time for FDA to recognize a sufficient number of accrediting bodies so that laboratories may then apply for accreditation.  In this regard, the compliance date for testing to be conducted by an accredited laboratory participating in FDA’s program would be no sooner than six months after FDA publishes notice of sufficient laboratory capacity.  Thus, mandatory testing by an accredited laboratory appears to be a couple of years away at the earliest.
  • On October 10, the FDA and FTC sent a joint warning letter to Rooted Apothecary LLC for illegally selling unapproved drug products containing cannabidiol (CBD) online with unsubstantiated claims that the products treat teething pain and ear aches in infants, autism, attention-deficit/hyperactivity disorder (ADHD), Parkinson’s and Alzheimer’s disease, among other conditions.
  • As described in the warning letter, the FDA and FTC stated that the company used its website, online store, and social media sites to make unfounded claims about its CBD products, some of which were also unlawfully marketed as dietary supplements. Examples of the claims include:
    • “Instead of synthetic chemical[s] that can have safety concerns, this blend uses the best of nature to help calm the inflammation and pain of teething, while also promoting sleepiness for your little one.”
    • “Increasing evidence suggests that CBD oil is a powerful option for pain . . . anxiety . . . and autism . . . It seems like an attractive and safe option for children.”
    • “CBD oil may have neuroprotective properties and may protect against neurological conditions, such as Parkinson’s and Alzheimer’s disease.”
    • “[P]ossible uses for CBD include helping with skin problems such as acne, autism, ADHD, and even cancer. It’s often used in conjunction with traditional treatments to provide extra help. Children can use high amounts of CBD safely and without any risk.”
  • Additionally, the FTC was concerned that one or more of the efficacy claims cited may not be substantiated by competent and reliable scientific evidence. Under the Federal Trade Commission Act, it is unlawful to advertise that a product can prevent, treat, or cure human disease unless the advertiser possesses competent and reliable scientific evidence that substantiates the claims made.
  • The FDA has not approved any CBD products other than one prescription human drug product to treat rare, severe forms of epilepsy. However, as our readers may recall, in July 2019, the FDA announced their commitment to evaluating potential regulatory pathways for CBD products to be lawfully marketed, and that the Agency would report their progress by early fall 2019. As of today’s blog, the Agency has yet to advise on such pathways. Nonetheless, in a press release related to the October 10 warning letter, Acting FDA Commissioner Ned Sharpless, M.D. stated that the CBD-related warning letters “should send a message to the broader market about complying with FDA requirements.” Additionally, he noted that as the Agency continues to examine potential regulatory pathways for the lawful marketing of cannabis products, protecting and promoting public health through sound, science-based decision-making remains top priority.  We will continue to report on developments that impact the use of CBD in FDA regulated products.
  • The Centers for Disease Control (CDC) has released its Surveillance for Food-borne Disease Outbreaks Annual Report, which includes an analysis of all foodborne illness outbreaks reported in 2017.   CDC found that 841 foodborne disease outbreaks were reported in 2017, resulting in 14,481 illnesses, 827 hospitalizations, 20 deaths, and 14 food product recalls.  These recent statistics show that the number of foodborne disease outbreaks has decreased as compared to 2015.  The CDC report summarizes data from the National Outbreak Reporting System (NORS), which local, state, and territorial health departments use to report all waterborne, foodborne, and enteric disease outbreaks to the CDC.
  • Norovirus was the cause of 35 percent of the outbreaks, followed by Salmonella, which caused 29 percent of the outbreaks, and shiga toxin-producing Escherichia coli, which caused 5 percent. Moreover, the highest number of outbreak-associated illnesses were from turkey (609 illnesses); fruit (521 illnesses); chicken (487 illnesses); and pork (376 illnesses).
  • CDC uses its annual report to acquire information on foods associated with outbreaks, which helps CDC identify foods most commonly reported in outbreaks and track how frequently certain foods are implicated.  The report also offers the agency insight into how well prevention measures are working, which can lead to new policies and practices.
  • On September 30, 2019, FDA announced the establishment of the Food Safety Dashboard, which is designed to measure the progress of the seven foundational rules of the Food Safety Modernization Act (FSMA), to track their impact, and to help FDA to refine its implementation of the rules. As FDA embarks on a New Era of Smarter Food Safety, continuing the successful implementation of FSMA will support the Agency’s goal of reducing illness and death due to preventable contamination of FDA-regulated human and animal food products, explained the Agency in a press release. (For more information on FDA’s New Era of Smarter Food Safety, see our September 28 blog.)
  • The initial metrics on the Food Safety Dashboard will begin to track outcomes for three FSMA rules in the areas of inspections and recalls. These are:
    • “Current Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls” rules for both human food and food for animals (preventive controls rules).
    • Imported food safety, including data relevant to the “Foreign Supplier Verification Program” (FSVP) rule.
  • “We plan to update the data for these three FSMA rules quarterly, with our goal being to ultimately publish metrics for all seven rules,” stated Acting FDA Commissioner Ned Sharpless and FDA Deputy Commissioner for Food Policy and Response Frank Yiannas in a statement about the Dashboard. They added, “Many factors will influence these data over time, especially in the early phases of implementation.” FDA expects that it will take several years to establish meaningful trends from the data on the Dashboard.
  • The Food Safety Dashboard is available as part of the FDA-TRACK program, the FDA’s agency-wide performance management system.
  • The United States Department of Agriculture (USDA) and the Food and Drug Administration (FDA) work jointly and with other federal agencies, as well as state, local, and tribal government agencies to develop and implement food defense strategies.  Food defense is the protection of food products from intentional contamination or adulteration intended to harm the public or cause economic disruption.  Food defense is a required component of food safety plans for all regulated food facilities.
  • USDA’s September 27, 2019 constituent update highlights the availability of resources on the agency’s Food Defense Tools, Resources, and Training webpage, which includes a link to FDA’s Food Defense Plan Builder.  Launched August 22, 2017 (as covered here), the Food Defense Plan Builder is software that may assist owners and operators of food facilities with developing personalized food defense plans for their facilities.  FDA updated the Food Defense Plan Builder on September 19, 2019 and is providing an informational webinar on October 10, 2019 (registration is required).
  • In addition to safeguarding the nation’s food supply against intentional contamination or adulteration that is perpetrated for the express purpose of causing public harm or economic disruption, food defense and recall plans also serve to protect the public from food that is tampered with through social media pranks.  As covered here, for example, a spurt of viral videos this summer of people licking or spitting on food prompted FDA to issue a reminder on strategies to prevent tampering and intentional adulteration of foods and cosmetics in grocery stores.

For help complying with regulatory requirements for food facilities, please email us at fooddrug@khlaw.com.

 

  • On August 26, the FDA issued a letter to all sectors of the papaya industry to take action to prevent future foodborne illness outbreaks. As noted in the letter, since 2011, consumers have been exposed to eight outbreaks caused by Salmonella serotypes linked to imported, fresh papaya. In June of this year, FDA started an investigation into an outbreak of Salmonella Uganda illnesses tied to the consumption of whole, fresh papaya imported from Mexico. While the 2019 outbreak is ongoing, the first seven outbreaks accounted for almost 500 reported cases of illness, more than 100 hospitalizations, and two deaths.
  • In the letter, the FDA stated that it intends to use all the tools and enforcement powers available to the Agency to further strengthen safeguards and prevent contaminated papayas from being imported into the U.S. Such tools include education, outreach, training, enforcement, and research activities.  However, the FDA noted that more must be done within the industry to protect customers and meet legal obligations, such as the requirements set forth under the Produce Safety Rule and the Foreign Supplier Verification Program. Thus, the Agency set forth a number of action items for the papaya industry to implement:
    • Assess the factors that make crops vulnerable to contamination. If a foodborne pathogen is identified in the crop or growing environment, a root cause analysis should be performed to determine the likely source of contamination. Procedures and practices that minimize that risk must be implemented.
    • Examine the use and monitoring of water used to grow, spray (pesticides, fungicides), move, rinse or wax crops to identify and minimize risks from potential hazards.
    • Adopt tools and practices needed to enhance traceability. Papayas are a perishable commodity, and traceability information should facilitate the rapid tracking of involved product to expedite its removal from commerce, prevent additional consumer exposures, and properly focus any recall actions.
    • Fund and actively engage in food safety research to identify the potential sources and routes of microbial pathogens and develop data-driven and risk-based preventive controls.
  • FDA noted that the pattern of recurrent outbreaks observed since 2011, including the 2019 illnesses, have involved papaya grown in Mexico. As mentioned in both the industry letter and an agency press release, the FDA has increased sampling and screening of papayas at the U.S.-Mexico border, and is actively collaborating with counterparts in the Mexican government to further prevention efforts. Additionally, FDA has issued a warning letter to the papaya importer, Agroson’s LLC, due to significant violations of the Federal Food, drug, and Cosmetic Act found at the facility in conjunction with the latest Salmonella outbreak.