FDA adds selenium to nutrients required in infant formula.

  • In 2013, FDA proposed to amend the infant formula regulations at 21 C.F.R. 107.100 to add selenium to the list of required nutrients.  78 Fed. Reg. 22442 (April 16, 2013). Although selenium was not recognized as an essential nutrient for infants when FDA established its regulations, in 1989, the Food and Nutrition Board of the National Research Council established a Recommended Dietary Allowance (RDA) for selenium for infants 0 to 6 months of age of 10.0 micrograms per day (μg/day).  Although not currently required in infant formula, all U.S. manufacturers add selenium to their infant formulas.
  • On June 22, 2015, FDA finalized the proposed rule; as of June 22, 2016, manufacturers will be required to add at least 2.0 micrograms of selenium per 100 kilocalories and no more than 7.0 micrograms per 100 kilocalories.  80 Fed. Reg. 35834 (June 23, 2015).  Additionally, infant formula labels will be required to list selenium in micrograms per 100 kilocalories.
  • Selenium becomes the thirtieth mandatory nutrient required in infant formula.  By amending the regulations, FDA is able to require manufacturers to add selenium within a specified range; FDA set both a minimum and maximum level because, although dietary intake of this trace mineral is essential, chronic, and more rarely, acute selenium toxicity have been reported.

New Seralini study questions safety of GM foods.

  • In 2012, Professor Gilles-Eric Seralini gained notoriety for publishing research that linked the consumption of genetically modified (GM) crops to long-term toxicity and cancer in rodents.  The study initially received significant media attention, but scientific experts roundly criticized the data and their quality.  Ultimately, the publishing journal withdrew the article.
  • Seralini has published a new study that purports to question historic industry safety data for pesticides and GM foods based on what he describes as inherent flaws in study methodology.  For his new study, Seralini tested the contents of dried animal feeds commonly used as “control diets” in laboratory toxicity studies and found traces of pesticides, heavy metals, dioxins and furans, PCBs, and GM constituents, apparently at levels likely to cause disease and to disrupt the endocrine and nervous systems of test animals.  Based on these results, Seralini concluded that any tests that purport to establish the safety of pesticides or GM foods based on comparisons between these “control diets” and test diets must be invalidated.
  • In light of the general consensus that GM foods are no less safe than “conventional” foods, the new Seralini study likely will be met with scientific criticism and media skepticism.  It is doubtful that the new study will have any significant impact on regulators or industry, and it remains to be seen whether even anti-GM organizations and activists are willing to embrace new data from the formerly-discredited researcher.

FDA issues guidance on food allergen labeling exemptions.

  • Since the enactment of the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), food producers have been required to identify the presence of major food allergens (milk, eggs, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans) on food labels.  In certain cases, however, food manufacturers may modify ingredients derived from major allergens such that the final ingredients pose no risk of harm to allergic consumers.  Under FALCPA, manufacturers who wish to obtain an exemption from the labeling requirement for a specific ingredient must submit either:  (1) a petition providing scientific information establishing that the ingredient “does not cause an allergic response that poses a risk to human health” or (2) a notification providing scientific information establishing that the ingredient “does not contain allergenic protein” (or providing information that FDA previously has determined via premarket review that the ingredient does not cause an allergic response that poses a risk to human health).
  • On June 18, 2015, FDA issued final guidance to assist manufacturers with the preparation of petitions and notifications to support exemptions from allergen labeling requirements.  The final guidance is not substantially different from the draft guidance on this topic that FDA issued in 2014.
  • To date, there have been very few petitions and notifications submitted to FDA seeking exemptions from allergen labeling requirements, and even fewer have resulted in successful outcomes.  It remains to be seen whether the issuance of final Agency guidance on this topic will revitalize and improve the success rate of submissions in this area.

Enforcement woes threaten an Oregon county’s GMO ban.

  • While much attention in the area of GM legislation has focused on Vermont’s labeling law, the fact remains that other U.S. jurisdictions have enacted laws in this area as well.  Specifically, local bans on the cultivation of genetically modified (GM) crops have been enacted in counties in Hawaii and Oregon.
  • One Oregon county’s ban took effect on June 13, 2015, but concerns have been raised about the actual costs of enforcement.  First, the potential annual costs of enforcing the ban have been estimated at a crippling $200,000 a year.  Second, a federal judge has allowed alfalfa growers in the affected county to proceed with a “takings” claim against the state, the success of which would result in a significant payout to farmers to compensate them for the loss of their GM crops.
  • Unless and until the federal government acts to regulate GM crops and GM labeling, much of the activity in this area will continue to occur at the state and local levels.  The challenges inherent in enforcing state or local bans and labeling requirements likely will continue to include issues of preemption, takings, and potentially exorbitant cost (both in terms of enforcement and legal battles to defend measures).  These issues highlight the continued conflicts and tensions surrounding the cultivation and consumption of GM foods in the U.S. and illustrate the increasingly pressing need for harmonized regulation.

FDA announces final determination that Partially Hydrogenated Oils are not GRAS.

  • In November 2013, FDA announced its tentative determination that partially hydrogenated oils (PHOs) were not generally recognized as safe (GRAS) based on the link between trans fats and health risks, such as coronary heart disease (CHD), as identified by scientific evidence and expert scientific panels, such as the Institute of Medicine (IOM) and the Centers for Disease Control and Prevention (CDC).  PHOs are the primary dietary source of industrially-produced or artificial trans fatty acids (trans fats).
  • On June 16, 2015, FDA issued a final determination and press release stating that there is no longer a consensus among qualified experts that PHOs are GRAS under any conditions of use in food.  Going forward, PHOs will be regulated as food additives, which — unlike GRAS substances — require FDA approval prior to use in food.  The food industry and other stakeholders have been anticipating FDA’s final determination for quite some time.  The industry voluntarily has removed a significant amount of trans fats from the food supply.  With respect to applications in which trans fats are not readily substitutable, a leading trade association — the Grocery Manufacturers Association (GMA) — has indicated its intent to submit a food additive petition (FAP) to permit the use of PHOs in specific food applications and at limited use levels.
  • Although FDA’s determination in this case comes as little surprise to the food industry and other stakeholders, this development is likely to receive significant attention in the coming weeks and months.  Many look to the trans fats example as a potential precursor to regulatory action involving other ingredients of concern – such as caffeine and sodium – and also as a potential precursor to regulatory restrictions or bans in other countries.

FDA issues preliminary findings on prevalence of Salmonella in pets.

  • Sporadic Salmonella contamination of pet foods has long been a source of concern to pet owners, as it has the potential to affect both human and animal health.
  • FDA has released preliminary findings from a Salmonella study, indicating that fewer than 100 pets (dogs and cats) out of nearly 3,000 tested positive for the bacterium.  Nearly half of the dogs who tested positive for Salmonella showed no symptoms of infection, and positive test results correlated with consumption of raw pet food.  FDA has indicated its plan to sample raw pet food products as part of its routine research and surveillance activities in 2015.
  • Overall, FDA’s findings represent positive news for pet owners.  Although Salmonella contamination remains of general concern, FDA’s data indicate relatively low prevalence of infection and also suggest concrete steps that can be taken to safeguard human and animal health against the existing risk.

Consumer groups ask FDA to ban 8 synthetic flavors.

  • Over the years, various consumer groups have urged legislators and regulators to take specific actions that they allege are necessary to strengthen the safety of the U.S. food safety supply.  To highlight one prominent example in recent years, consumer groups have mounted and maintained a steady attack on the GRAS process.
  • On June 10, 2015, the Center for Science in the Public Interest, Natural Resources Defense Council, Center for Food Safety, Consumers Union, Improving Kids’ Environment, Center for Environmental Health, and Environmental Working Group filed a petition with FDA requesting that the Agency ban eight (8) synthetic flavors currently permitted for use in a variety food products.  The petition alleges that the substances are now known to be carcinogens and thus are unsafe for use under the “Delaney Clause” (a provision of the Federal Food, Drug, And Cosmetic Act that precludes a finding of safety for food additives that are found “to induce cancer in man or animal”).  Specifically, the consumer groups seek the prohibition of the following substances:
    1. Benzophenone (also known as diphenylketone);
    2. Ethyl acrylate;
    3. Eugenyl methyl ether (also known as 4-allylveratrole or methyl eugenol);
    4. Myrcene (also known as 7-methyl-3-methylene-1,6-octadiene);
    5. Pulegone (also known as p-menth-4(8)-en-3-one);
    6. Pyridine;
    7. Styrene; and
    8. Trans,trans-2,4-hexadienal.
  • The petition highlights the challenge inherent in strict interpretation of the Delaney Clause.  All eight substances have been marketed for decades in the U.S. and are used at low levels in food, suggesting that the risk of carcinogenicity may be attenuated in real-life conditions.  Nevertheless, the petition urges adoption of a strict “zero tolerance” standard that would ignore any “dose makes the poison” argument and would result in the ban of any substances that induce cancer in humans or animals.  If the Delaney Clause were to be enforced as strictly as the petition urges, one wonders how many food additives and GRAS substances would find themselves on the chopping block in future.

House votes to repeal COOL requirements for meat.

  • As previously covered on this blog, U.S. country of origin labeling (COOL) rules for meat products have long been the subject of controversy and challenge, culminating in a World Trade Organization (WTO) ruling that the COOL requirements violate U.S. trade obligations to Canada and Mexico.  The WTO ruling essentially forces Congress to repeal the COOL requirements to avoid trade sanctions.
  • On June 10, 2015, the U.S. House of Representatives passed a bill that would repeal the COOL requirements.
  • Despite some critics’ view that international trade agreements should not interfere with U.S. requirements intended to provide consumers with clearer information about the source of their meat products, the repeal of COOL will be greeted with approval by the U.S. meat industry (which has long opposed the requirements) and will avoid U.S. exposure to retaliatory tariffs from Canada and Mexico.

“100% Natural” claim challenged on products that contain GM ingredient. (subscription to Law360 required)

  • As the food industry is well aware, lawsuits challenging “natural” claims continue to proliferate nationwide, with particularly significant activity occurring in the Northern District of California (dubbed “The Food Court”).  Many challenges have focused on the presence or use of synthetic ingredients or processing aids in products positioned as “all-natural” or “100% natural.”
  • More recently, we have seen a trend toward “natural” challenges that focus on the presence of genetically modified (GM) constituents in food products.  In a lawsuit filed on June 8, 2015, a plaintiff has challenged Campbell Soup Co.’s “100% Natural” claim on Prego brand pasta sauces, citing the presence of GM canola oil in the products.  The challenge is premised on the allegation that reasonable consumers would not expect the presence of GM ingredients in a product positioned as wholly natural.  Considering that most (if not all) modern crops are “GM” based on the use of historical preferential breeding techniques, there is at least a reasonable argument that the use of GM technology does not render crops per se synthetic or artificial.
  • This is not the first GM-based “natural” challenge, nor is it likely to be the last.  The potential liability involved in such cases can be significant, as indicated by Kashi’s recently finalized $4 million settlement to end a class action lawsuit over the presence of GM components in its cereals and snack bars.  FDA has no official policy governing the use of “natural” claims, nor does the Agency appear likely to develop a definition in the foreseeable future.  In the meantime, the food industry’s actions in the “natural” claim space will likely continue to be shaped — and curtailed — by plaintiffs’ lawyers.

North Carolina’s recently enacted “Ag-Gag” law imposes civil consequences for interfering with private property.

  • “Ag-Gag” legislation generally seeks to prevent individuals or organizations from investigating and publicizing farming conditions and practices that occur on private property.  Several states have introduced and enacted Ag-Gag measures to date, but Utah’s and Idaho’s laws currently face constitutional challenges on 1st and 14th Amendment grounds.
  • In June 2015, North Carolina’s legislature enacted the “Property Protection Act” by overriding the Governor’s veto of H.B. 405.  Although the law is worded broadly enough to cover various industry sectors (e.g., nursing homes), the media has been focusing on its Ag-Gag implications.  Unlike other state Ag-Gag measures, the North Carolina law provides for civil remedies for interference with property, rather than criminal actions.  The law provides for recovery against a person who enters non-public areas of a premises to recover information subsequently used to breach that person’s “loyalty to the employer.”  Liability also extends to the use of surveillance (images, sound, or electronic) in non-public areas.  An employer may file a civil lawsuit and seek up to $5,000 per day for every day that violations continue.
  • The North Carolina provisions — and indeed, Ag-Gag laws in general — are likely to remain the subject of controversy in the weeks and months ahead.  Animal welfare activists view Ag-Gag laws as impeding the discovery and dissemination of information on improper or abusive farming practices.  The agriculture industry views Ag-Gag measures as necessary to protect farming operations from infiltration by undercover activists, corporate espionage, undue interference, and unwarranted negative publicity.  Particularly as Ag-Gag laws continue to be considered and challenged in other states, it remains to be seen whether North Carolina’s unique approach to providing civil remedies will be adopted elsewhere.