FDA and EPA to share data on pesticides and toxic substances.

  • FDA and EPA share regulatory authority over substances that are used in food (including animal food and feed), animal drugs, and cosmetics.  For example, the manufacturer of an antimicrobial food wash must demonstrate to FDA that the use of this substance is safe and does not adulterate food.  The manufacturer also may be required to demonstrate to EPA that use of the same substance (which constitutes a pesticide) will not have unreasonable adverse effects on the environment.
  • In recognition of their mutual role in assessing the safety of regulated products, FDA and EPA have entered into a Memorandum of Understanding (MOU) to facilitate the sharing of information (including non-public information) related to the agencies’ regulation of substances over which jurisdiction is shared.
  • Although the MOU specifically addresses the agencies’ plans to use proper safeguards against unauthorized use and disclosure of the non-public information shared under the agreement, the industry understandably may be concerned about appropriate treatment of confidential or commercially sensitive data exempt from disclosure under the Freedom of Information Act (FOIA).  It remains to be seen exactly how FDA and EPA will coordinate their responses to FOIA requests going forward, but future submitters of confidential information to either agency should be aware of the increased potential for inter-agency data sharing.

Ninth Circuit ruling shines spotlight on the “trans fat free” claim arena.

  • A “nutrient content claim” is a claim that expressly or implicitly characterizes the level of a nutrient of the type required to be in nutrition labeling.  As a general matter, FDA must authorize specific nutrient content claims.  For years, there has been debate over whether FDA has authorized claims highlighting the absence of trans fat from food.
  • The Ninth Circuit recently addressed this issue in the context of a false advertising lawsuit; it considered whether FDA’s nutrient content claim requirements preempted state law claims that a “No Trans Fat” statement on a food label was misleading.  In finding the claims not preempted, the Ninth Circuit concluded that FDA did not authorize a “No Trans Fat” claim.
  • In reality, FDA has issued several warning letters addressing “trans fat free” claims over the years, indicating its acceptance of “0 g trans fat” (where an appropriate disclosure is made regarding the presence of fat, saturated fat, sodium, and cholesterol over certain levels) and its rejection of “trans fat free” and “no trans fat” as unauthorized nutrient content claims.  Interestingly, however, FDA issued a warning letter in January 2015 indicating that “[a]lthough FDA has not defined the term, ‘no trans-fat’ by regulation…[the Agency] would likely consider exercising enforcement discretion for a trans-fat nutrient content claim that is demonstrably true, balanced, adequately substantiated, and not misleading.”  Between the recent warning letter and the newly minted Ninth Circuit ruling, the possibility exists for increased scrutiny and state litigation in the “trans fat free” claims arena.

TTB approves labels for powdered alcohol, clearing the way for U.S. commercial marketing.

  • Even before the Alcohol and Tobacco Trade and Tax Bureau (TTB) issued and rescinded label approvals for powdered alcohol (“Palcohol”) in 2014, many interested and concerned parties have been preparing for the likely commercial marketing of this product.
  • In March 2015, TTB issued final approval for four product Palcohol labels, which will permit the marketing of these products in the U.S.  Across the country, legislators have moved to ban the marketing of Palcohol in their states.  Senator Schumer (D-NY) has introduced federal legislation to make the production, sale, and possession of Palcohol illegal as well.
  • Many stakeholders have voiced concerns about the public health and safety risks potentially associated with Palcohol.  According to the product manufacturer, both “FDA and the TTB [] have reviewed Palcohol and tested it and found no problems with allowing it to go forward to be approved for sale.”  Comparisons already are being made between Palcohol and Four Loko, the caffeinated alcoholic beverage for which FDA issued warning letters citing the addition of caffeine as an “unsafe food additive.”  Although the degree of FDA’s premarket regulatory involvement is unclear, it remains to be seen whether and how the Agency will take postmarket steps to investigate the safety of this controversial product.

FDA issues small entity compliance guide on menu labeling requirements.

  • On December 1, 2014, FDA published a final rule to implement the menu labeling provisions added to the Federal Food, Drug, and Cosmetic Act (FD&C Act) by the Affordable Care Act.  Under the new requirements, restaurants or similar retail food establishments (in chains of 20 or more locations doing business under the same name and selling substantially similar menu items) must provide calorie and other nutrition information for standard menu items.
  • FDA has released a small entity compliance guide to help the industry understand the scope and coverage of the rule and compliance dates, as well as specifics of the new requirements.
  • Although the menu labeling requirements do not take effect until December 1, 2015, covered entities should be working actively toward compliance at this time.

Additional state AGs join probe into supplement marketing.

  • The New York Attorney General’s (AG) investigation into the marketing of allegedly misbranded herbal supplement continues to develop.  The investigation commenced with theissuance of cease-and-desist letters to major retailers, sparked a series of class action lawsuits, and then shifted focus to target supplement manufacturers and claim substantiation.
  • AGs from Connecticut, Indiana, and Puerto Rico have formed a coalition with the NY AG, which likely will result in the investigation expanding to other states.
  • Considering the ongoing regulatory, industry, and consumer interest in the dietary supplement market, it seems unlikely that this particular investigation will fade quickly or quietly.
  • Debates over the pros and cons of labeling Genetically Modified (GM) foods and ingredients continue to be waged in federal and state legislative bodies and among industry and consumer groups more generally.
  • New England states have thus far achieved the most legislative “success” in this space, with Vermont’s law currently slated to take effect (although it is being challenged) and with Maine and Connecticut having enacted laws whose effectiveness is contingent on legislative action by additional surrounding states.  Rhode Island and Massachusetts now are poised to consider GM labeling bills of their own.
  • Although campaigns for state-required GM labeling have failed in California, Colorado, Oregon, and Washington, the Northeast states remain a region to watch.  The resolution of the Vermont legal challenge, the enactment of additional GM laws, and the potential for federal legislative action in this space all could mark significant changes in the food industry’s approach to GM labeling in the future.

FDA survey finds few drug residues in U.S. dairy supply.

  • FDA partners with the states to ensure the safety of the U.S. milk supply, which includes monitoring milk products for drug residues.  Under the Pasteurized Milk Ordinance (PMO) — a model ordinance published by FDA and adopted by individual states — raw milk samples must be collected and tested for the presence of specific antibiotics.  If illegal drug residues are present, the milk may not be sold for human consumption.
  • In 2012, FDA collected milk samples from nearly 2,000 farms with the primary purpose of determining whether dairy farms with previous residue violations have more drug residues in milk than other dairy farms.  FDA has released the results from its milk sampling survey, stating that more than 99% of the samples were free of drug residues.
  • Although FDA’s constituent update affirms the safety of the U.S. milk supply, certain media outlets have focused on the violative findings.  FDA’s news release comes on the heels of other developments indicating growing consumer unease with antibiotics in the food supply, along with the food industry’s continuing efforts to reduce the use and presence of these drugs.

Family sues over caffeine-related death.

  • On March 6, 2015, the family of Logan Stiner, an Ohio teenager who died from cardiac arrhythmia and cardiac arrest after consuming pure powdered caffeine, filed a wrongful death suit under the Ohio Food & Drug Safety Act.  The suit names as defendants Amazon.com, six other companies involved in manufacturing, marketing, distributing and selling the product, and Logan’s high school classmate, who allegedly supplied him with the caffeine powder.  Following Stiner’s death, FDA posted a consumer advisory warning of the dangers of consuming powdered pure caffeine.
  • According to the complaint, the pure caffeine powder was “unsafe and dangerous” and the companies “knew or should have known” that the product at issue was “dangerous, or likely to be dangerous when used in a reasonably foreseeable manner.”  The complaint alleges that the product is a misbranded drug, based on, among other things, the listing of pure caffeine in the U.S. Pharmacopeial Convention (USP) and further alleges that the defendants “have successfully avoided meaningful regulation of [their] product by the U.S. Food and Drug Administration (FDA) by classifying their product as a ‘dietary supplement.'”
  • The case underscores the responsibilities businesses involved in manufacturing, marketing, distributing, or selling products have to ensure their products are safe when used in a reasonable foreseeable manner.  Regulatory and product liability risks are greatest for products that arguably meet the definition of “drug” under Section 201(g)(1) of the Food, Drug, and Cosmetic Act but are marketed as dietary supplements, conventional foods, medical foods, or cosmetics and are therefore not subject to FDA approval.

WHO recommends reducing daily intake of free sugars to less than 5% of total energy intake.

  • Since 1989, the World Health Organization has recommended reducing intake of free sugars (those added to foods and drinks and those naturally present in honey, syrups, fruit juices and fruit juice concentrates) to less than 10% of total daily energy intake.  WHO states this advice is based on the connection between a high level of free sugars intake and poor dietary quality, obesity, and risk of noncommunicable diseases.
  • The new guidance document includes a “conditional recommendation” to further reduce free sugars intake to less than 5% of total daily energy intake, or about six teaspoons for an average adult.  This recommendation is based on evidence WHO describes as “very low quality” linking 5% or less daily energy intake from free sugars to reduction in dental caries.
  • According to Harvard’s School of Public Health, the average American consumes 22 teaspoons of added sugar a day, so complying with WHO’s recommendation would require a drastic reduction.  A single can of a non-diet soft drink typically contains more sugar (30 g) than would be allowed under the 5% recommendation for an entire day (25 g), raising questions as to whether the 5% recommendation is a realistic target.

FDA fails to meet foreign inspection targets under FSMA.

  • Under the FDA Food Safety Modernization Act (FSMA), FDA was required to inspect 600 foreign food facilities in the first year post-enactment, followed by a doubling of the prior year’s inspection numbers for the each of the next five years.
  • According to a GAO report, FDA inspected only 1,323 foreign facility inspections in 2014, far short of the targeted 4,800 sites.  According to the GAO report, FDA has not met, and does not plan to meet, its FSMA targets.
  • There exists a series of disconnects between the FSMA target inspection goals, FDA’s pervasive funding struggles, the number of vacant FDA foreign office positions, and questions about whether the FSMA targets are necessary to ensure the safety of the foreign food supply.  It remains to be seen whether FDA will respond to the GAO’s urging that the Agency evaluate the sufficiency of its foreign inspection practices to protect the public health.

Bill introduced in Senate to combat overuse of antibiotics in food-producing animals.

  • For years, FDA and various stakeholders have grappled with how best to reduce the use of medically important antibiotics to promote growth or feed efficiency in food-producing animals.  In 2013, FDA asked animal pharmaceutical companies to voluntarily revise the FDA-approved conditions of use on antibiotic labels to remove production indications.
  • Senators Dianne Feinstein (D-CA) and Susan Collins (R-ME) have reintroduced a bill that would require FDA to withdraw its approval of medically important antibiotics that are at a high risk of abuse in food-producing animals.  The sponsors and supporters of the legislation argue that it addresses gaps in FDA’s 2013 request for voluntary industry participation in the reduction of antibiotic abuse.
  • Antibiotic resistance remains a pressing public health concern.  Future actions by the federal government with respect to reducing antibiotic use have the potential to affect multiple sectors of industry, including animal pharmaceutical manufacturers, farmers, food processors, and even ethanol producers (as antibiotics may be used in ethanol production, the by-products of which are fed to food-producing animals).