• FDA’s Center for Veterinary Medicine (CVM) has released a new guidance document (Guidance for Industry #3:  General Principles for Evaluating the Human Food Safety of New Animal Drugs Used In Food-Producing Animals) describing the types of information that the Center expect to see when such drugs are used in food-producing animals.
  • Under Section 512(b)(1) of the Federal Food, Drug and Cosmetic Act, sponsors of new animal drugs are required to demonstrate the safety in edible tissues.  The guidance addresses topics including:
    • Determining an acceptable daily intake (ADI);
    • Calculating safe concentrations;
    • Assignment of a tolerance;
    • Calculation of a withdrawal period and a milk discard time; and
    • Evaluation of carcinogenic compounds

This general guidance provides references to other CVM guidance documents that provide more detailed information on specific topics, such as conducting specific types of toxicity testing to evaluate residues of veterinary drugs (e.g., Guidance for Industry #116: Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing).

  • Importantly, the guidance acknowledges that it is designed to address “traditional” new animal drugs that consist of small molecules and that it may not be applicable to evaluating the safety of “non-traditional” new animal drugs (e.g., biotechnology-derived new animal drugs, including some enzymes, fusion proteins, synthetic hormones, and antibodies).  In these latter cases, CVM may be willing to consider alternative approaches to address toxicological concerns.  In those cases, CVM recommends that the sponsor contact CVM early in the drug development process to develop studies to address toxicological concerns.
  • As previously reported on this blog, in March 2018, House Agricultural Committee Chairman Michael Conway delayed the release of the draft law renewing farm and nutrition programs due to opposition to cuts to the Supplemental Nutrition Assistance Program (SNAP). SNAP offers nutrition assistance to more than 47 million eligible, low-income individuals and families, and is authorized and subsidized by the farm bill. However on May 18, 2018, the U.S. House of Representatives voted down its version of the farm bill.
  • The Senate released its bipartisan draft of the farm bill on June 8, 2018. The bill, titled the Agricultural Improvement Act of 2018, is largely a continuation of the current farm bill, which passed in 2014. The Senate’s draft bill takes a more conventional approach than the House version, and does not include the same controversial work requirements for SNAP that appeared in the House’s proposal.
  • Other notable provisions in the Senate bill include:
    • Re-authorization of the Farm and Ranch Stress Assistance Network (FRSAN), which is a mental health resources program established by the 2008 farm bill, but never funded. This provision allocates $10 million through 2023 and requires USDA to report to Congress on the state of mental health in farming communities.
    • Funding for the Organic Certification Cost Share Program (which reimburses producers who apply for organic certification) and the Organic Agriculture Research and Extension Initiative (which funds projects for organics research and development).
    • Modernize the Food for Peace program, which provides nutritional assistance around the world.
    • Legalize hemp as an agricultural product and make the plant eligible for crop insurance.
    • Bring back the position of Under Secretary for Rural Development at the USDA, which Secretary Sonny Perdue eliminated in 2017.
  • The bipartisan bill is likely to pass in some form. The Senate Agricultural Committee will vote on the bill today, June 13, 2018.
  • Several U.S. Senators introduced a bipartisan bill titled, Strengthening the Tenth Amendment Through Entrusting States Act (STATES Act), on June 7. The bill would allow states, U.S. territories, and federally recognized tribes to choose how to regulate the use of marijuana within the borders of their state without federal interference. However, the bill would leave certain provision of the federal Controlled Substances Act in place. These include prohibiting the endangerment of human life during marijuana manufacturing and the distribution of marijuana at rest areas and truck stops.
  • The bill was introduced by Senators Elizabeth Warren (D-Mass.) and Cory Gardner (R-Colo.) and Representatives David Joyce (R-Ohio) and Earl Blumenauer (D-Ore.) who indicated that forty-six states have already passed laws permitting or decriminalizing marijuana or marijuana-based products.
  • The STATES Act also amends the definition of “marijuana” under the Controlled Substances Act to specifically exclude industrial hump. (Marijuana and industrial hemp come from the same genus of flowering plant cannabis, but industrial hump has a very low concentration of the psychoactive chemical, tetrahydrocannabinol (THC), while marijuana plants contain a high level.) The governor of Colorado recently signed a bill into law that stipulates that food and cosmetics are not adulterated or misbranded for containing industrial hump and applies existing food manufacturing guidelines to food products containing industrial hemp.
  • Many states were concerned after Attorney General Jeff Session announced in January that he was ending a policy from the Obama-era that banned the U.S. Department of Justice from spending money to interfere with the implementation of state medical marijuana laws. Furthermore, as previously stated in this blog, FDA has implied that it may start to investigate some marijuana health claims and benefits. Since Sessions’ announcement, though, several marijuana-related bills have been introduced in Congress, however, a Medill News Service article points out that the STATES Act seems more likely to pass due to is emphasis on states’ rights.

 

  • As previously reported on this blog, FDA sent Warning Letters to five companies that distributed pure powdered caffeine in 2015 and advised that it intended to “aggressively monitor the marketplace for pure powdered caffeine products and take action as appropriate.”  FDA stated in the letters that it concluded that pure powdered caffeine is adulterated under Section 402(f)(1)(A)(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) based on the potential toxicity of the product.  On April 13, 2018, FDA issued a new guidance to clarify that dietary supplements containing pure or highly concentrated caffeine in powder or liquid forms are considered unlawful when sold in bulk quantities directly to consumers.
  • FDA has recently made public two additional Warning Letters involving bulk forms of dietary supplements with pure or highly concentrated caffeine.  FDA’s May 29, 2018 Warning Letters, to the sellers of Caffeine Anhydrous Powder, a pure caffeine powder sold in bulk to consumers, and the sellers of Liquid Caffeine, a highly concentrated liquid form of caffeine sold in bulk to consumers, note potential difficulties for consumers in accurately measuring a safe dose of these products.  Liquid Caffeine is the first liquid caffeine dietary supplement to be targeted by FDA.  FDA’s letter on Liquid Caffeine states:

In light of the potential toxicity of your product; the fact that your product is packaged to contain an amount that would be toxic several times over, and potentially lethal to certain consumers; the fact that the packaging requires the consumer to separate out a safe serving from this potentially toxic amount; the fact that the product labeling incorrectly implies that this process of separating out a safe serving from a potentially toxic amount can be done with a pump, which is not in fact sold with the product; and the fact that the product is instead co-packaged with a measuring device that holds 6 “one-pump” servings of your product, but is labeled with a different unit of measurement from the directions, such that consumers might not understand how many servings it contains and assume that it contains one serving; we have determined that your product presents a significant or unreasonable risk of illness or injury under the conditions of use recommended or suggested in the labeling.

  • FDA’s continuing actions against bulk quantities of dietary supplements with pure or highly concentrated caffeine show that the Agency considers potential overdosing with caffeine to be a very serious risk for these products.

 

  • On June 7, FDA and CDC released the results of the 2017 National Youth Tobacco Survey.  Total number of high- and middle-school tobacco users of any tobacco product continued to fall to unprecedented levels, dropping over 20% between 2011 and 2017, from approximately 4.56 million to 3.62 million youth users.  Comparing tobacco use as a percentage of population, use amongst high-school students dropped from 1 in 4 in 2011 to 1 in 5 in 2017 and from 1 in 13 middle-school students in 2011 to 1 in 18 middle-schoolers in 2017.  The positive results continue to make clear that any fear of a “gateway” effect to smoking from use of reduced harm products like e-cigarettes is, so far, unfounded. While acknowledging the reduction, both CDC and FDA are actively seeking further reduction in youth tobacco use, and highlight concerns over youth e-cigarette use and nicotine addiction.
  • FDA took the opportunity of the release of the Survey results to reiterate and expand upon its Youth Tobacco Prevention Plan.  FDA has taken steps, including warning letters, requests for information, advertising campaigns, focus groups with youth, youth use surveys, and further regulation to limit youth use.  FDA also acknowledged, once again, that e-cigarettes “may present an important opportunity for adult smokers to transition off combustible tobacco products and onto nicotine delivery products that may not have the same level of risks associated with them.”
  • You can read more about FDA’s regulation of tobacco, including the 2017 National Youth Tobacco Survey, from Keller and Heckman’s Tobacco and Vapor Practice on its blog, The Continuum of Risk, including and as guest authors on Law360 (subscription required).
  • On June 1, the Trump Administration announced that it will extend tariffs on steel and aluminum to Mexico, Canada, and the European Union (EU), which originally had been exempted from the tariffs when announced in March.  The tariffs impose a 25% tax on steel imports and 10% tariff on aluminum imports.
  • Canada has announced that it plans to impose surtaxes or other countermeasures on food products, including yogurt, pizza, cucumbers, prepared foods, and coffee.  Mexico is considering imposing countermeasures on pork, sausage, fresh fruit, and cheeses.  The EU list of goods proposed for retaliatory action includes corn, kidney beans, rice, cranberries, and whiskey.
  • The food and beverage industry and agricultural associations have criticized the tariffs, which have the potential to have far reaching impacts—from producers of affected products to consumers paying higher prices for goods.
  • On June 5, 2018, FDA and USDA announced a new collaborative effort to streamline produce safety requirements for farmers by aligning the USDA Harmonized Good Agricultural Practices Audit Program (USDA H-GAP) with the requirements of the FDA Food Safety Modernization Act’s (FSMA’s) Produce Safety Rule. This effort follows the signing of a formal agreement in January 2018 that outlined plans to increase interagency coordination regarding produce safety, inspections of dual jurisdiction facilities, and biotechnology activities.
  • As previously mentioned on this blog, FDA’s Produce Safety Rule establishes science-based minimum standards for the safe growing, harvesting, packing, and holding of produce.  Our detailed summary of the rule is available here. The USDA H-GAP Audit Program is an audit developed as part of the Produce GAP Harmonization Initiative, an industry-driven effort to develop food safety GAP standards and audit checklists for pre-harvest and post-harvest operations. H-GAP audits focus on best agricultural practices to verify that fruits and vegetables are produced, packed, handled, and stored in the safest manner possible to minimize risks of microbial food safety hazards.
  • While the requirements of both programs are not identical, the relevant technical components in the Produce Safety Rule are covered in the H-GAP Audit Program. The aligned components include areas such as biological soil amendments; sprouts; domesticated and wild animals; worker training; health and hygiene; and equipment, tools and buildings.
  • This coordinated effort will help farmers by enabling them to assess their food safety practices as they prepare to comply with the Produce Safety Rule. But USDA audits are not a substitute for FDA or state regulatory inspections. Both FDA and USDA are committed to working together to ensure that the requirements and expectations of the programs are aligned. This effort represents the agencies’ latest initiative to streamline regulatory responsibilities and use government resources more efficiently to protect public health.
  • An independent panel advising the World Health Organization (WHO) did not recommend taxing sugary drinks in a report, titled, “A Time to Deliver.” While the report, released June 1, 2018, recommends that governments give priority to restricting the marketing of unhealthy products (that contain excessive amounts of sugars, sodium, saturated fats and trans fats) to children, it stops short of calling for taxes on sugary beverages. The report does, however, recommend increasing taxes on alcoholic beverages and tobacco products.
  • The lack of a recommendation to tax sugary beverages is surprising since WHO has been recommending for decades that free sugars be reduced in daily diets. In January 2018, we blogged about a WHO report urging the food industry and global governments to take active steps to slow sugar’s contribution to childhood obesity. Later that year, WHO issued a report calling for a tax on sugary drinks.
  • Several news outlets have reported that the Trump administration was behind the decision to not call for a beverage tax in the report. According to a S. News and World Report article, Dr. Sania Nishtar, co-chair of the WHO panel, said most of the panel’s 26 members supported a tax on sugar-sweetened beverages but panel member Eric Hargan, U.S. Deputy Secretary for Health and Human Services, opposed the tax.
  • We have been reporting on the soda tax debate for several years now (see Soda Tax Battles Continue into 2018, Five More U.S. Cities to Tax Soft Drinks, and United Kingdom’s Sugar Tax on Beverages Takes Effect as examples). We will continue to keep our readers up-to-date on efforts to tax sugary beverages and other foods.
  • A May 24 letter from nine consumer and food safety groups urges the U.S. Food and Drug Administration (FDA) “to designate produce, including leafy greens, as a high-risk food category and propose regulations that will enhance product tracing for produce in the event of an outbreak.”  The six-page letter was signed by the Center for Foodborne Illness Research & Prevention; Center for Science in the Public Interest; Consumer Federation of America; Consumers Union; Food & Water Watch; National Consumers League; The Pew Charitable Trusts; STOP Foodborne Illness; and Trust for America’s Health.
  • As discussed in this blog, FDA and the Centers for Disease Control and Prevention (CDC) are investigating a multistate outbreak of E. coli O157:H7 illnesses linked to romaine lettuce from the Yuma, Arizona growing region.  A June 1, 2018 update to FDA’s website (devoted to the ongoing investigation), indicates the Arizona Leafy Greens Marketing Agreement has confirmed that romaine lettuce is no longer being produced and distributed from the Yuma growing region and the last date of harvest was April 16, 2018 (i.e., well beyond the 21-day shelf life for Romaine).  However, as noted in the May 24, 2018 letter from consumer and food safety groups, the source of the E. coli contamination has not been precisely identified.  Regarding the lack of traceability requirements for produce, the May 24, 2018 letter states “FDA has no means to swiftly determine where a bag of lettuce was grown or packaged.”
  • Farms are entirely excluded from the traceability requirements of the Bioterrorism Act.  Further, while the Food Safety Modernization Act (FSMA) Produce Safety Rule established specific recordkeeping requirements, traceability coding is not a requirement.  FDA completed a study on enhancing traceability and issued a FSMA-mandated Report to Congress in 2016, but has yet to create a list of high-risk foods and issue a proposed rule for enhanced recordkeeping.
  • It is unlikely that FDA will establish traceability requirements for high risk foods or produce a list of high risk foods (which could potentially include leafy greens) within the 6-month timeframe that is requested by the May 24, 2018 letter.  But greater adoption throughout the supply chain of the Produce Traceability Initiative (PTI),  a voluntary industry system introduced years ago, would make it easier for agencies to track supply chains when investigating illness outbreaks.  It is estimated that only 60% of produce is shipped in cases that have PTI labels.  Other companies may use different traceability programs, using their own codes for a field, a season, a production location, or a commodity.  Consistency in traceability programs would improve the speed and accuracy of tracebacks.
  • On May 24, the United States Department of Agriculture’s (USDA’s) Food Safety and Inspection Service (FSIS) issued a guideline: FSIS Guideline for Determining Whether a Livestock Slaughter or Processing Firm is Exempt from the Inspection Requirements of the Federal Meat Inspection Act.  Absent an exemption, all establishments where cattle, goat, swine, or sheep are slaughtered or processed for sale must be inspected by FSIS.  FSIS regulations found at 9 CFR Part 303 provide for exemptions for slaughter for personal use, custom slaughter, slaughter in an unrecognized Territory for distribution in that Territory, certain retail and restaurant use.
  • Initial determination regarding exemptions is made by the individual claiming the exemption, but may be confirmed by FSIS.  Additionally, though an activity or facility may be exempt from inspection, there may be other requirements, including that the livestock be fit for human consumption and that the carcass not prepared, packed, or held under insanitary conditions.  In some cases the requirements include recordkeeping.  State and local laws may still apply.
  • One point of interest from the guideline: In some cases the ownership of the livestock or carcass is key.  For example, consider an animal slaughtered at a ranch with all of the meat being delivered to an individual for his and his family’s personal consumption.  If the ranch slaughters its own animal and sells the meat to the individual no exemption applies.  However, if the ranch sells the animal to the individual and then slaughters the animal for that individual’s personal use, the custom slaughter exemption might apply.  If, instead, the animal is purchased by the individual and slaughtered by the individual at the ranch the personal use exemption might apply.
  • FSIS is accepting comments for 60 days after publication.  Keller and Heckman would be happy to assist in preparing and submitting comments for any interested parties.