FDA Continues its Enforcement Efforts Aimed at Companies Marketing Kratom Products

  • On May 22, 2018 FDA announced that it had issued warning letters to three companies marketing kratom products with medical claims.  FDA’s letter asserts that the claims that the products could be used as pain killers, to reduce opioid dependence, to treat diabetes, to lower blood pressure, and to treat other ailments; are medical claims that have not been reviewed by the Agency.  Such claims, when not approved by FDA, render the products unapproved new drugs.
  • FDA Commissioner Gottlieb indicated that these warning letters are part of a concerted effort to fight the opioid epidemic.  The effort by FDA includes a commitment to “make the approval process more efficient for novel, safe and effective medical treatments aimed at the treatment of addiction; and to help more people suffering from addiction get access to approved therapies.”  Commissioner Gottlieb encouraged kratom manufacturers to provide FDA a new drug submission if the manufacturers have data that can substantiate medical claims.  Commissioner Gottlieb’s call for submissions specifically noted pain treatment or opioid addiction claims.
  • These warning letters come on the heels of widespread salmonella contamination of kratom containing products, resulting in multiple recalls, a 2016 seizure of kratom products promoted with unapproved drug claims, and FDA’s general emphasis on addressing the opioid crisis.  The actions are also consistent with FDA’s recent crackdown on youth tobacco use, another FDA strategic priority.  It is clear that FDA is taking, and will continue to, take, aggressive steps to pursue its strategic priorities.  For manufacturers, distributors, and retailers of products that might be impacted, increased vigilance to ensure compliance with all regulations and laws impacting the your products is in order.  Those wishing to make medical claims on products will need to determine if such claims will render their product a new drug and take actions (potentially including submitting new drug application to FDA) consistent with this assessment.

The Daily Intake will return on Tuesday, May 29.  We extend our best wishes to those of you celebrating the Memorial Day holiday.

Missouri and France Prohibit Labeling Plant-Based Products as “Meat”

  • The Missouri Senate has passed an omnibus spending bill that adopts SB 977, the state bill that prohibits the marketing of plant-based meat analogs with the term “meat.”  The bill has been passed by the Missouri House and now goes to the governor for signing.  The bill had the support of the Missouri Farm Bureau, Missouri Cattlemen’s Association, and the Missouri Pork Association and was opposed by the Plant Based Foods Association.
  • The Missouri law comes on the heels of a similar law that passed on April 13, 2018 in France (Amendment No. CE2044), which prohibits the use of terms including filet, bacon, or sausage to be used for meatless products.
  • Similarly, Arkansas recently passed a resolution calling for a standard for rice (that would prohibit the marketing of riced cauliflower, for example, as “cauliflower rice”).  At the federal level, the Dairy Pride Act seeks to limit the ability to market non-dairy alternatives to milk with terms like milk, yogurt, and cheese.  These initiatives may mark a trend of increased state and federal activity on standards of identity and naming of foods.

FDA Warns Companies Illegally Marketing Dietary Supplements as Sunscreen

  • On May 22, 2018, FDA sent warning letters to companies illegally marketing dietary supplements that make unproven drug claims about sun protection without meeting FDA’s standards for safety and effectiveness. FDA said the companies are “putting people’s health at risk by giving consumers a false sense of security that a dietary supplement could prevent sunburn, reduce early skin aging caused by the sun, or protect from the risks of skin cancer.” FDA instructed the companies to correct all violations associated with their products and were advised to review product labeling and websites to ensure that the claims do not violate federal law. Examples of claims include “Enhances photoprotection,” “It’s basically an oral sunscreen,” and “Every second you spend in the sun damages your skin. But Sunsafe Rx is always working: it protects your whole body,” according to the FDA’s letters.
  • In a statement released by FDA Commissioner Scott Gottlieb, M.D., it was made clear that there is no pill or capsule that can replace sunscreen. Commissioner Gottlieb stated that legitimate sunscreens are made in a wide range of sun protection factor values, also known as SPF values, and are over-the-counter drugs that come in many forms. These include lotions, creams, sticks and sprays. All of these formulations are applied topically over the skin and must pass certain tests before they’re sold.
  • FDA is not authorized to review dietary supplement products for safety and effectiveness before they are marketed. However, FDA can take dietary supplements off the market if they are found to be unsafe or if the claims on the products are false and misleading.

Aquaculture Company’s Woes in Washington State Continue

  • The Washington Department of Fish and Wildlife (WDFW) recently rejected Cooke Aquaculture’s request to move 800,000 Atlantic salmon into Puget Sound net pens. WDFW cited two reasons for denying the permit.
    • The Atlantic salmon that would have been transported to the Puget Sound net pens tested positive for a form of the fish virus PRV (piscine orthoreovirus) that occurs at the Iceland hatchery where the company sources salmon eggs. That form of PRV is not known to occur in Puget Sound, so WDFW classifies it as “exotic” in Washington.
    • Cooke proposed to place fish into pens that have not been emptied for at least 30 days after the most recent harvest of adult fish, which would contradict the company’s own management plan.
  • This is not the first setback for Cooke with regards to salmon farming in Washington State. As previously reported on this blog, Washington State passed a bill to phase out Atlantic salmon and other non-native fish farming. Washington Governor Jay Inslee signed that bill (HR 2957 ) on March, 22, 2018. The new law prohibits the state of Washington from issuing any new permits for “activities associated with the use of marine net pens for nonnative marine finfish aquaculture…” Current leases will continue to be honored. Cooke plans to continue to operate its net pens in the state until its leases expire in 2022, reports WDFW.
  • A driving factor in Washington state’s actions concerning farming of Atlantic salmon has been to protect Pacific salmon that is native to the waters around the state. Efforts to ban salmon farming in Washington State began shortly after more than 240,000 Atlantic salmon escaped from a Cooke net pen in August 2017. That net pen was located near Cypress Island in Puget Sound. Shortly after the governor signed HR 2957, Sen. Kevin Ranker (D-Orcas Island), who sponsored the bill stated, “We’ve invested so much in trying to recover our wild pacific salmon populations, there is no sensible purpose for allowing non-native species into the Salish Sea. The day-to-day impact of invasive aquaculture — feces, disease, loose food pellets or lice — could have serious impacts. The state ban is a strong stance to ensure the protection of our marine environment and native salmon populations in the Salish Sea.”

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

 

  • 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

  • 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

  • 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)

  • 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

  • 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

 

  • 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.

 

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