FDA’s ‘Data Dashboard’ Expansion Makes Supply-Chain Verification Searches Easier

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  • Three FDA Food Safety Modernization Act (FSMA) rules (Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals; Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food; and Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals) require importers and facilities to evaluate their suppliers’ compliance with food safety laws and the Food and Drug Administration’s (FDA) regulations.  FDA created a Supplier Evaluation Resources page that lists multiple FDA databases that can be searched to determine whether a supplier is the subject of an FDA warning letter, import alert, or other FDA compliance action related to food safety.
  • Last week, a new section was added to FDA’s DATA DASHBOARD to provide a tool for searching multiple databases relevant to supply-chain verification requirements in a single search.  Anyone can search by entering all or part of a firm’s name, or the firm’s FDA Establishment Identifier (FEI).  Results may return several rows, including many with the same name.  Address information can be used to distinguish locations since each company location will display a separate firm profile.
  • We caution, however, that relying solely on the new consolidated search tool to discover relevant information will not likely satisfy importers’ and facilities’ supply-chain verification obligations because the dashboard search encompasses only finalized and completed FDA actions.  In addition, it is also not clear whether the databases are comprehensive.  For example, the bottom of the “results” page from a dashboard search includes a caveat: “Actions pertaining to foreign firms often take the form of import alerts, and are currently not reported in this Dashboard release,” suggesting the new consolidated search tool does not locate import alerts, which are relevant to evaluating a supplier’s performance and the risk associated with a food under the FSVP and the supplier approval process under the Preventive Controls rules.  However, for at least some companies, the search results include Import Alert information under a tab called “Import Alert & Warning Letters.” Regulated companies should use the search tool as one part of their supplier assessment efforts.  Please feel free to contact Keller and Heckman at fooddrug@khlaw.com with any questions about FSMA supply-chain verification requirements.

 

FDA Extends Compliance Dates for Certain Uses of Partially Hydrogenated Oils in Food; Denies Petition for PHO Use

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  • As previously discussed in this blog, in November 2013, FDA announced its tentative conclusion that partially hydrogenated oils (PHOs) are not generally recognized as safe (GRAS).  In June  2015 FDA issued a final determination the PHOs are not GRAS and must be regulated as food additives – which require FDA approval prior to use in food.  As we blogged about further, subsequent to FDA’s determination that PHOs are not GRAS, a leading food industry trade association, the Grocery Manufacturers Association (GMA) filed a food additive petition for certain PHOs present in low levels in foods when used as carriers for color additives and flavoring agents, pan release agents for baked goods, and as processing aids.
  • Today FDA announced that foods manufactured using PHOs before June 18, 2018 may remain on the market until January 1, 2020 to accommodate the shelf life of the products.
  • FDA’s announcement also indicated that it is denying the GMA petition “because the petitioners did not provide sufficient evidence that the requested uses are safe.”  FDA did acknowledge that industry may need additional time to find replacements for the PHOs that were the subject of the petition, so the PHOs that were the subject of the petition have until June 18, 2019 to be removed from manufactured food and foods manufactured before this date have until January 1, 2021 to remain on the market.
  • FDA’s tables summarizing the extended compliance dates is reproduced below:

 

Non-Petitioned Uses
Product Uses Original Compliance Date Extended Compliance Date
Manufacturing of food with non-petitioned uses of PHOs June 18, 2018 Not extended
Foods manufactured with non-petitioned uses of PHOs before June 18, 2018 June 18, 2018 January 1, 2020
Petitioned Uses
Product Uses Original Compliance Date Extended Compliance Date
Manufacturing of food with the petitioned uses of PHOs June 18, 2018 June 18, 2019
Foods manufactured with the petitioned uses of PHOs before June 18, 2019 June 18, 2018 January 1, 2021

Non-Profits Sue FDA to Prohibit Use of Seven Flavors

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  • Eight non-profit organizations (Breast Cancer Prevention Partners, Center for Environmental Health, Center for Food Safety, Center for Science in the Public Interest, Environmental Defense Fund, Environmental Working Group, Natural Resources Defense Council, and WE ACT for Environmental Justice) are suing FDA to seek a prohibition on the use of various flavors in food.  The lawsuit is the latest non-profit effort to compel FDA action after the Agency has not acted on a citizen petition.  In this case, a citizen petition was filed in 2016 requesting that FDA amend its regulations to no longer authorize the use of the same synthetic flavoring food additives and to establish zero tolerances for the additives.
  • The seven flavors at issue, which are cleared under 21 CFR 172.515 (“Synthetic flavoring substances and adjuvants”), are benzophenone (also known as diphenylketone), ethyl acrylate, eugenyl methyl ether (also known as 4-allylveratrole or methyl eugenol), myrcene (also known as 7-methyl-3-methylene-1,6-octadiene), pulegone (also known as p-menth-4(8)-en-3-one), pyridine, and styrene.  The complaint, filed in the U.S. Court of Appeals for the Ninth Circuit, alleges that these substances cannot be added to food because they are carcinogens under the Delaney Clause, as set out in Section 409(c)(3)(A) of the Federal Food, Drug, and Cosmetic Act.
  • The Styrene Information and Research Center (SIRC)  has submitted a petition to FDA, requesting that the Section 172.515 listing for styrene be removed because its use as a flavoring has been permanently abandoned.  It will be interesting to see whether additional abandonment petitions are filed for any of the other six flavors targeted in the suit.

U.S. Senators Urge Trump Administration to Protect Use of Cheese Names in NAFTA (Law360 subscription required)

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  • On May 14, 2018, two dozen U.S. senators urged the Trump administration to protect the use of common cheese names in the North American Free Trade Agreement (NAFTA). Spearheaded by Sens. Tammy Baldwin, D-Wis., and Pat Toomey, R-Pa., the senators implored the administration to make sure that any new NAFTA deal is not hindered by rules of the EU-Mexico agreement that give EU producers exclusive rights to market certain cheeses under geographic names.
  • As background to this issue, in April 2018, the European Union (EU) and Mexico announced they reached an agreement to update their 18-year-old bilateral trade agreement. The new deal would remove duties for all agricultural goods, offer protections for some EU cheese names, and create Mexican tariff-rate quotas for EU milk powder and cheese. The agreement would give new market access to the EU by introducing tariff-rate quotas for EU cheese exports to Mexico. During a five-year period, Mexico would gradually raise a quota of 20,000 tons for mature cheeses and 5,000 tons for fresh cheeses.
  • The U.S. and EU have long battled over geographical indications (GIs) for products and was one of the core issues that prevented talks for the Obama-era Transatlantic Trade and Investment Partnership from progressing. The GIs pursued by the EU are commonly sold in the U.S., such as parmesan, which the EU believes must refer only to a cheese from the Parma region of Italy. However, such a rule would be in conflict with Mexico’s NAFTA commitments. According to the senators, “[i]f Mexico grants European cheese producers exclusive rights to use common cheese names, as reports indicate it has agreed to do, American producers will lose market share they have spent years developing.”
  • We reported a similar issue on this blog in 2017, and as previously mentioned, granting the EU GI protections could cost the U.S. dairy industry billions of dollars. For example, U.S. producers shipped $1.3 billion worth of cheese to Mexico in 2017. Keller and Heckman will continue to monitor and report on the status of GIs within NAFTA.

WHO Offers Plan to Eliminate Industrially-Produced Trans Fatty Acids

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  • One week after suggesting that adults and children reduce their intake of trans fatty acids to less than 1% of total energy intake (see our May 8, 2018 blog for details), the World Health Organization (WHO) released a plan aimed at eliminating industrially-produced trans fatty acids from the global food supply. The plan, REPLACE, is in the form of a step-by-step guide.
  • REPLACE consists of six steps:
    • REview dietary sources of industrially-produced trans fats and the landscape for required policy change
    • Promote the replacement of industrially-produced trans fats with healthier fats and oils
    • Legislate or enact regulatory actions to eliminate industrially-produced trans fats
    • Assess and monitor trans fats content in the food supply and changes in trans fat consumption in the population
    • Create awareness of the negative health impact of trans fats among policy makers, producers, suppliers, and the public
    • Enforce compliance of policies and regulations
  • WHO estimates that trans fat leads to more than 500,000 deaths of people from cardiovascular disease each year. WHO is calling on governments to use the REPLACE action package to achieve the elimination of industrially-produced trans fatty acids from the global food supply, which was identified as one of the priority targets of WHO’s strategic plan, the draft 13th General Programme of Work (GPW13). As part of the U.N.’s Sustainable Development Goals, the global community has committed to reducing premature death from noncommunicable diseases by one-third by 2030.
  • As previously reported on this blog, the U.S. Food and Drug Administration issued a final determination on June 16, 2015, revoking the GRAS status for partially hydrogenated oils (PHOs) based on the link between trans fats and health risks. The compliance date is June 18. FDA has in presentations indicated that recalls of products containing PHO’s will not be required where the products were introduced in interstate commerce before that date (IEG Policy – subscription required). Agency officials promise further clarification will also be provided shortly.

FDA Releases Small Entity Compliance Guide Reiterating January 2018 Guide on Extension of Certain Compliance Dates for Four FSMA Rules

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  • As previously covered on this blog, on August 24, 2016, FDA published a final rule that extended and clarified the compliance dates for certain provisions in four of the foundational rules implementing the Food Safety Modernization Act (FSMA).  The implicated rules are (1) Preventive Controls for Human Food Rule, (2) Preventive Controls for Food for Animals Rule, (3) Produce Safety Rule, and (4) Foreign Supplier Verification Programs (FSVP) Rule.  FDA’s January 2018 “Policy Regarding Certain Entities Subject to the Current Good Manufacturing Practice and Preventive Controls, Produce Safety, and/or Foreign Supplier Verification Programs: Guidance for Industry” announced FDA’s intent to exercise enforcement discretion with regard to the facilities and requirements that are addressed in the August 24, 2016 rule.
  • Section 212 of the Small Business Regulatory Enforcement Fairness Act (SBREFA) requires FDA to publish a small entity compliance guide (SECG) to assist small entities in complying with actions like the August 24, 2016 final rule on the four FSMA provisions and to explain and clarify the actions that a small entity must take to comply with the rule. The notification of availability of the guidance document “Food and Drug Administration Food Safety Modernization Act; Extension and Clarification for Certain Provisions of Four Implementing Rules: What You Need to Know About the Food and Drug Administration Regulation; Small Entity Compliance Guide” (May 2018 SECG) was published in 83 Fed. Reg. 22193 (May 14, 2018).
  • The May 2018 SECG does not include any new substantive information and simply confirms FDA’s previous advice by directing the reader to the January 2018 guidance.  The “new” document appears to satisfy the Agency’s SBREFA obligations to provide guidance to small entities regarding the August 2016 final rule.  Please feel free to contact Keller and Heckman at fooddrug@khlaw.com with any questions about the FSMA compliance dates.

 

United States Issues WTO Counter Notification Against India’s Market Price Support

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FDA Releases Intentional Adulteration Training Course

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  • In partnership with the Food Safety Preventive Controls Alliance (FSPCA), FDA has developed a free 30-minute “Food Defense Awareness for the Intentional Adulteration (IA) Rule” online training course to assist industry in complying with Food Safety Modernization Act (FSMA) requirements under the Final Rules for Mitigation Strategies to Protect Food Against Intentional Adulteration.
  • The training is the first in a series of six anticipated training materials to be released in partnership with FSPCA; the subsequent trainings will cover: (1) an overview of the IA rule, (2) IA “key activity types, (3) IA identification and explanation of mitigation strategies, (4) vulnerability assessments, and (5) food defense plan preparation and reanalysis.
  • The IA rules require covered facilities to develop and implement a food defense plan that protects the facility’s most vulnerable points from acts of intentional adulteration intended to cause wide-scale public health harm.  The newly-released training course is separate from guidance documents that FDA is developing and planning to issue in installments in advance of the July 26, 2019 compliance date for most businesses. As reflected in recent comments by Commissioner Scott Gottlieb, there is confusion among industry concerning just what the rules require from industry.

U.S. House Representatives Work with USDA to Address Food Waste

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  • As previously covered on this blog, food waste is a major issue in the United States.  Government estimates indicate that Americans waste between 30 and 40% of the overall food supply on an annual basis.  According to the USDA, consumers are responsible for nearly 90 billion pounds of food waste each year, which equates to 20% of the U.S. food supply. And while perfectly good food goes to waste, approximately 40 million Americans are food insecure.
  • On April 30, 2018, Congressman David Young (R-IA) and Congresswoman Chellie Pingree (D-ME) launched a House Food Waste Caucus to explore opportunities to reduce food waste. The bipartisan Caucus will explore ways to promote food waste reduction across the food supply chain, provide educational opportunities to congressional members and staff, support efforts to reduce food waste at federal agencies including USDA and EPA, and collaborate with diverse stakeholders to highlight food waste success stories.
  • In connection to the Caucus, on May 8, 2018, USDA Secretary Sonny Perdue hosted a food waste roundtable with Reps. Pingree and Young, food industry leaders, and non-profit groups to raise awareness around food waste and to discuss solutions with leaders throughout the entire food supply chain. Secretary Perdue stated the need to “change the culture and adopt a holistic approach” to tackle food waste.
  • The House Caucus is not the first attempt by Congress to address food waste. In 2016, Rep. Pingree and Senator Richard Blumenthal (D-CT) introduced H.R. 5298 – The Food Date Labeling Act, which aimed to establish a uniform national system that distinguishes between foods bearing a label indicating peak quality from foods bearing a label that indicates a potential safety risk if they are consumed after the listed date.  The bill would also ensure that food is allowed to be sold or donated after a quality-based date. And while the bill was not enacted, the House Caucus demonstrates Congress’s continued effort to reduce food waste.

WHO Targets Saturated and Trans Fatty Acids

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  • The World Health Organization (WHO) released draft guidelines on saturated fatty acid and trans-fatty acid intake for adults and children. The draft guidelines suggest that adults and children reduce their intake of saturated fatty acids to less than 10% of total energy intake and their intake of trans-fatty acids to less than 1% of total energy intake. Furthermore, the draft guidelines recommend using polyunsaturated fatty acids as a source of replacement energy, if needed. The objective of the recommendations is to reduce the risk of noncommunicable diseases (NCD’s) in adults and children.
  • The WHO first issued population nutrient intake goals for the prevention of NCD’s in 1989. (We reported on WHO’s recommendation to reduce free sugars intake to less than 5% of total daily energy intake in 2015.)  WHO Member States and all relevant stakeholders may comment on the draft guidelines between May 4 and June 1, 2018. (A call for public comments on the draft guidelines, along with directions for accessing the draft guidelines, can be found on WHO’s website.)
  • While the WHO is a respected public health body, decisions about appropriate regulatory responses to the organization’s recommendations are made by individual governments. In the U.S., the Food and Drug Administration (FDA) issued its final rules to implement changes to nutrition labeling requirements on May 20, 2016. Both sugars and fats are addressed in the new nutrition labeling requirements that are currently scheduled to take effect on January 1, 2020 for manufacturers with $10 million or more in annual foods sales and on January 1, 2021 for manufacturers with less than $10 million in annual food sales. More specifically, the final rule on Food Labeling: Revision of the Nutrition and Supplement Facts Label requires added sugars to be included on the Nutrition Facts label, which is a new requirement. The amount of saturated fat and trans fats per serving is listed on the current label and will be required on the new labels, however, listing of “calories from fat” will not be required on the new labels. The full global impact and response to the WHO’s recommendations on saturated fatty acids and trans-fatty acids remains to be seen, however.
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