FDA Highlights Best Practices to Prevent Tampering and Intentional Adulteration of Food and Cosmetics

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FDA Announces Modernization of NDIN Electronic Submission System

  • FDA has announced that it is launching a new electronic submission system for New Dietary Ingredient Notifications (NDINs) on Friday, September 6.  The new system, the CFSAN Online Submission Module (COSM) is replacing the current FDA Unified Registration Listing System (FURLS). 
  •  NDINs are required to be submitted to FDA at least 75 days before marketing a dietary supplement with a new dietary ingredient.  However, FDA has lamented in its NDIN guidance that NDINs are not commonly submitted.  Approximately 1100 NDINs have been submitted since 1995.  The new system will also be used for structure/function claim notifications (SFCNs), which are required to be submitted to FDA no later than 30 days after the first marketing a dietary supplement that bears a structure/function claim. 
  •  FDA announced this initiative in a Federal Register notice in May 2019, noting that the Agency expects an increase in the average number of NDINs being submitted over the next three years.  For a preview of the COSM system, you can view screenshots on FDA’s website.



Amidst Regulatory Uncertainty, Cell-Based Meat Startups Form Coalition

  • As previously reported on this blog, the U.S. Department of Agriculture (USDA) and the U.S. Food and Drug Administration (FDA) have announced an agreement to share regulatory oversight over cell-based or cell-cultured meat. As part of the agreement, FDA will conduct premarket consultation to evaluate the manufacture of these products, including oversight of tissue collection, cell lines and banks, and all components of inputs.
  • The agencies have previously agreed that no additional legislation would be necessary to effectuate the joint agreement. No additional guidance or proposed regulations have been published by either FDA or USDA at this time.
  • In light of this regulatory uncertainty, five cell-based meat and seafood companies have formed a coalition to represent the industry. The coalition, Alliance for Meat, Poultry & Seafood Innovation (AMPS Innovation) includes five founding member companies, BlueNalu, Finless Foods, Fork & Goode, JUST, and Memphis Meats. These companies are currently in the research and development phase but expect to make products available in the next several years. In a joint statement, members noted the purpose of the coalition is to “speak with a unified voice as we emerge as a viable, impactful partner in the overall food and agriculture sector.”

CSPI & Consumer Reports Petition to USDA on “Uncured” and “No Nitrate or Nitrite Added” Claims

  • USDA’s Food Safety and Inspection Service (FSIS) is responsible for monitoring the proper use and labeling of nitrates/nitrites by meat processors. Nitrate and/or nitrites have been historically used as synthetic curing agents to preserve fresh cut meats such as bacon. Meats are now more frequently prepared using celery powder and other non-synthetic sources of nitrates and nitrites which can produce similar antimicrobial properties, taste, and appearance to synthetic nitrates and nitrites. Nitrosamines are formed as a reaction from the use of nitrates/nitrites in meat which has been shown to be carcinogenic in animal studies.
  • For new processed meats that do not use synthetic nitrates/nitrites, FSIS requires the label to bear the term “Uncured” and the statement: “Uncured Bacon, No Nitrates or Nitrites Added” with the qualifier, “except for those naturally occurring in [name of ingredient that is source of nitrates/nitrites].”
  • In an August 29, 2019 petition submitted to FSIS, the Center for Science in the Public Interest and Consumer Report (the Petitioners) called on the Agency to stop requiring the terms “Uncured” and “No Nitrate or Nitrite Added” on labels for meat processed with nitrates or nitrites from non-synthetic sources, such as celery powder. The Petitioners cite recent tests that showed that nitrates and nitrites are found in processed meats labeled “Uncured” or “No Nitrates or Nitrites Added” at similar levels to those prepared with synthetic curing agents. As such, the Petitioners argue that those labels are misleading consumers to think meats with those claims are healthier and request that FSIS revise its rules so that the “Uncured” and “No Nitrate or Nitrite Added” claims can only be made on meats prepared with no nitrates or nitrites from any source. Additionally, the Petitioners request that all products processed using nitrates/nitrites bear the disclosure “Nitrates or nitrites added.”

Keller and Heckman attorneys are available to advise on the labeling of meat and poultry products in compliance with USDA labeling requirements.  For assistance, please email: fooddrug@khlaw.com.

FDA Announces Public Meeting to Discuss Modernizing Food Standards of Identity

  • FDA will hold a public meeting on September 27, 2019 to give interested parties an opportunity to discuss FDA’s effort to modernize food standards of identity (SOI) and to provide information about changes the FDA could make to existing standards of identity.  Modernizing standards of identity is part of the agency’s Nutrition Innovation Strategy, with the agency first prioritizing the use of the term “milk” in labeling plant-based products.
  • The public will have a chance to discuss FDA’s effort to modernize food standards of identity and provide information about changes the agency could make to existing standards, particularly changes that could be made across categories of standardized foods (i.e., horizontal changes), to facilitate innovation and provide flexibility for the development of healthier foods.  Three breakout sessions will address various topics, including: (1) nutrition topics: what changes to existing SOI would encourage production of more nutritious foods; (2) issues related to innovation and what horizontal approaches to modernization could better accommodate advances in science and technology; and (3) issues related to consumer expectations and standardized foods.
  • Written/electronic comments may be submitted beginning August 29, 2019. Persons interested in attending this public workshop either in-person or by web viewing must register online by September 20, 2019.

U.S. Dealing with Several Hepatitis A Outbreaks, Including One Due to Food Worker Infection

  • Public health officials in Mendham, New Jersey are dealing with a relatively rare instance of a foodborne hepatitis A outbreak due to an ill food handler.  The employee has been linked to illnesses in 27 people, with 1 death reported.
  • According to the Centers for Disease Control and Prevention, foodborne outbreaks of hepatitis A are not common in the U.S.  CDC does not recommend that all food service workers receive routine vaccination against hepatitis A—except in areas with an active community-wide outbreak and where state and local health authorities (or private employers) indicate that vaccination would be cost-effective.
  • There are hepatitis A outbreaks in Alabama and Nevada where infected food handlers have been identified but where illnesses have not been traced to such workers.  Twenty-five counties in Alabama are reporting cases of hepatitis A in an outbreak that has been ongoing since September 2018, including among food workers; officials are urging food handlers in that area to get vaccinated.  Officials in Las Vegas, which also has an ongoing outbreak with 86 cases and one death, have warned customers who purchased non-prepackaged foods at a 7-Eleven store where a worked tested positive for hepatitis A to be on the lookout for symptoms.
  • CDC’s hepatitis A surveillance is updated through 2016.  Thus, it is not yet clear whether the 2019 cases reflect a marked increase in the incidence of hepatitis A in the U.S.

FDA Calls on Papaya Industry to Take Action to Prevent Foodborne Illness Outbreaks

  • 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.

Injunction to Stop Enforcement of Meat Labeling Law Not Needed, Says AR

  • As our readers are aware, a number of states have enacted laws to prohibit marketing a product as “meat” if it is not derived from livestock or poultry and that several of these laws—including ones in Mississippi, Missouri, and Arkansas—have been challenged in court. (Other states that have enacted similar laws include Louisiana, North Dakota, South Dakota, Oklahoma, and Wyoming.)
  • The Arkansas Truth in Labeling Law (Act 501) includes the following definitions:
    • Beef: the flesh of a domesticated bovine, such as a steer or cow, that is edible by humans
    • Pork: the flesh of a domesticated swine that is edible by humans
    • Poultry: domestic birds that are edible by humans

Under this law, misbranding or misrepresenting an agricultural product can result in a fine of up to $1,000. As we previously reported on this blog, two days before the Arkansas law was scheduled to become effective, on July 22, 2019,  the American Civil Liberties Union (ACLU), The Good Food Institute, the Animal Legal Defense Fund, and Tofurky filed a lawsuit in the U.S. District Court for the Eastern District of Arkansas claiming that Act 501 violated the First and Fourteenth amendments.

  • Earlier this month, the Plaintiffs asked the court to issue a preliminary injunction to stop enforcement of the law while the case is being decided (see Turtle Island Foods, SPC doing business as The Tofurky Company v. Nikhil Soman, in his official capacity as Director of the Arkansas Bureau of Standards, Case No. 4:19-cv-514-KGB). In response to Tofurky’s request, the Arkansas Attorney General’s office explained that since the lawsuit challenging the constitutionality of the labeling law was filed before the law was scheduled to take effect, the Arkansas Bureau of Standards decided not to enforce it yet and, therefore, there is no threat of irreparable harm to support an injunction (Vox Media).
  • U.S. sales of plant-based meat grew 37.1% between April 2017 and April 2019 to reach $801 million in the year ending in April 2019, reports the Good Food Institute. We will continue to monitor and report on legal and regulatory activity in this area.

USDA’s Proposal to Close SNAP Automatic Eligibility “Loophole” Faces Pushback from U.S. Mayors

  • On July 24, 2019, the U.S. Department of Agriculture’s (USDA) Food and Nutrition Service (FSN) published a proposed rule, “Revision of Categorial Eligibility in the Supplemental Nutrition Assistance Program (SNAP)” aiming to close what it calls an automatic eligibility “loophole” in the program. As background, the law authorizing SNAP includes specific income and asset standards to qualify for SNAP benefits, but the law also allows states to confer “categorical eligibility” on those who have already been certified for similar means-tested programs (i.e., programs that check income, assets, etc. to ensure applicants are eligible, such as the Temporary Assistance for Needy Families (TANF)).
  • Some states have expanded the use of categorical eligibility so that households who receive TANF benefits are automatically eligible to participate in the SNAP, without having to qualify for the federal income or assets limits for SNAP. The administration is calling this expansion a “loophole” as some households may qualify under SNAP when they would otherwise not under regular program rules, with USDA Secretary Sonny Perdue stating that “For too long, this loophole has been used to effectively bypass important eligibility guidelines. Too often, states have misused this flexibility without restraint.”
  • Under the new rule, an estimated 3.1 million people would lose their food assistance under SNAP. On August 21, 2019, in a letter to an administrator for SNAP, 70 U.S. mayors rejected the proposal. “This proposal will put children’s health and development at risk by removing their access to healthy school meals; and harm our economy by reducing the amount of SNAP dollars available to spur regional and local economic activity.” Written comments on the proposed rule must be received on or before September 23, 2019.

Update on the Regulation of CBD-Infused Products

  • As previously reported on this blog, state regulators want a role in the regulation of CBD-infused food, beverages, and supplements. And while industry has been pressuring FDA to create a pathway for the lawful use of CBD in food and dietary supplements, currently, under the Federal Food, Drug and Cosmetic Act (FD&C Act), CBD (or cannabidiol) cannot lawfully be added to a food or marketed as a dietary supplement.
  • Washington State Department of Agriculture (WSDA) updated its website this month to clarify that hemp-derived CBD is not permitted as a food ingredient or additive. WSDA points out that while food processors licensed in the state of Washington may currently use certain hemp products in foods—such as hulled hemp seeds, hemp seed protein power, and hemp seed oil—”[o]ther parts of the hemp plant, including CBD, cannot be used as a food ingredient under a Washington State Food Processor License.” The department further states, “Recognizing that these recent changes in law may have caused some confusion in the manufactured-food industry, WSDA has been reaching out to the industry so they can take appropriate actions, such as removing CBD ingredients from their products or discontinuing distribution of CBD-containing food products in the state.”
  • As recently as last week, Cara Welch, FDA’s Acting Special Assistant to the Deputy Commissioner for Policy Legislation & International Affairs, reminded attendees at the American Herbal Products Association Hemp-CBD Supplement Congress that it is prohibited to add CBD to food. Noting that, “There is still a significant amount of missing data to better understand the effects on human exposure and the long-term effects of regular consumption,” Welch pointed out that some studies show some toxic effects on the liver in high doses, and there is inadequate research about the use of CBD by pregnant or nursing mothers or people with low immunity (see U.S. News). She added, “We’re trying to be as transparent and informative as possible on these issues, and to resolve open questions quickly, efficiently, but also thoughtfully.”
  • Preliminary data on the growth of hemp-derived CBD was presented during the AHPA Congress. AHPA reports in a press release on the Hemp-CBD Congress that, hemp-derived CBD sales ballooned to $238 million, an increase of 57% in 2018 over the previous year, according to Nutrition Business Journal. Additionally, hemp acreage under license across the U.S. increased nearly five-fold in the past year from 112,000 acres in 2018 to 480,000 acres in 2019, according to data gathered by advocacy group votehemp.com. We will continue to report on developments in the regulation of CBD-infused food, beverages, and supplements.

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