Alaskan senator threatens to block nominee for FDA commissioner over GE salmon

  • In November 2015, FDA issued its first approval for a genetically engineered animal intended for direct human consumption — the AquAdvantage Salmon, an Atlantic salmon engineered to grow twice as fast as its natural counterpart — and released guidelines on voluntary GM labeling. Sen. Lisa Murkowski (R-Alaska) helped insert language in the omnibus bill passed in December 2015 that requires FDA to block the sale of any product containing GE salmon during fiscal year 2016, unless the Agency publishes “labeling guidelines for informing consumers of such content.”
  • On January 12, 2016, a Senate health committee advanced the nomination of Robert Califf as the next commissioner of the FDA. However, at the committee meeting, Murkowski vowed to block Califf’s confirmation until FDA agrees to require labeling for GE salmon, stating she wants to make sure FDA knows that “voluntarily labeling is not adequate” and “doesn’t comply with what is now law.” Murkowski says she discussed her concerns over GE salmon with Califf when he was before the committee for his confirmation hearing in November, and that Califf, who currently serves as FDA’s deputy commissioner, was “not direct” with her regarding the Agency’s intentions. The FDA announced its approval of AquAdvantage Salmon and released guidelines on voluntary GM labeling two days after the confirmation hearing.
  • Califf, a former Duke University researcher and cardiologist, has been widely expected to win confirmation from the full Senate, but Murkowski’s concerns regarding GE salmon – which she acknowledged are “very parochial” – may prove a stumbling block. FDA has historically taken the position that labeling should be required only if a GM product is materially different from its conventional counterpart; as previously covered on this blog, on November 19, 2015, the Agency denied a Citizen Petition filed by the Center for Food Safety that would have required labeling of food derived from GM crops.

USDA’s Agricultural Marketing Service withdraws the standards for “grass fed” and “naturally raised” marketing claims

  • The Agricultural Marketing Service (AMS) of the USDA provides the livestock and meat industries with an option to voluntarily have marketing claims covered by AMS standards verified by the USDA, and to identify such claims as “USDA Certified”.  AMS established standards for grass (forage) fed livestock marketing claims in 2007 and for naturally raised marketing claims in 2009.  See 72 Fed. Reg. 58631 and 74 Fed. Reg. 3541.
  • On January 11, AMS announced it has determined that the “grass fed” and “naturally raised” marketing claims do not fit within the agency’s statutory authority.  AMS explained that persons seeking to use these USDA-verified claims on product labels must receive pre-approval from the USDA’s Food Safety and Inspection Service (FSIS) or meet FDA labeling requirements.  AMS has concluded that, because AMS does not have express Congressional authority to define these claims, and because there is no guarantee that an USDA-verified production/marketing claim will be approved by FSIS or permitted by FDA, the standards for marketing claims “do[] not facilitate the marketing of agricultural products in a manner that is useful to stakeholders or consumers.”
  • Current users of the USDA Grass (Forage) Fed Marketing Claim Standard must identify a new Grass-fed Standard their company intends to meet by February 11, 2016 and must implement the new standard by April 11, 2016. This may be accomplished by (1) converting the USDA Grass (Forage) Fed Marketing Claim Standard into their private grass-fed standard, (2) using another recognized grass-fed standard, or (3) developing a new grass-fed standard.  There are no current users of the USDA Naturally Raised Marketing Claim Standard.  Although AMS has identified a legitimate issue – lack of coordination between partner agencies – AMS’ solution has drawn swift criticism from those who say the policy will create non-uniform labels and erode consumer trust in “grass fed” claims.  A conference call will be held for stakeholders on Thursday, January 14, 2016.

Chobani’s latest ad campaign targets ingredients in Dannon and Yoplait products

  • Yoplait and Dannon have accused competitor Chobani of using false and misleading statements about their products in Chobani’s latest ad campaign.  In newspaper, television, and social media advertisements that began airing January 6, 2016, Chobani states that unlike its Simply 100 yogurt, Yoplait Greek 100 contains potassium sorbate as a preservative and Dannon Light & Fit Greek uses the artificial sweetener sucralose, which contains chlorine.  Potassium sorbate is a common preservative, which Chobani’s ad campaign describes as “used to kill bugs.” Sucralose is an FDA-approved ingredient commonly used in reduced-calorie foods; chlorine is used to make sucralose extremely sweet without adding calories.
  • Chobani contends that the campaign “provides consumers with accurate information to help them make more informed decisions about their food choices, including the choice between natural [ingredients] and artificial [ingredients]”; Dannon argues the ads “falsely disparage the safety of harmless ingredients and unnecessarily alarm consumers as to the safety of the foods they each” and “[a]s a result, both Dannon and the public at large are harmed by [the] advertising.”
  • In recent years, consumers have become more sensitive to ingredients in the food they eat.  PepsiCo and Coca-Cola removed brominated vegetable oil from Gatorade after a teenager started a petition to have the ingredient removed from soft drinks. Subway removed azodicarbonaide after Vani Hari, better known as the “Food Babe”, branded the ingredient “the yoga mat chemical.” Whether Chobani’s latest advertising campaign represents a new trend in companies calling attention to ingredients in their competitor’s products that consumers may wish to avoid – even if the ingredients have been safely and widely used in food for years – remains to be seen.

Campbell Soup announces support for mandatory GMO labeling

  • The effective date for Vermont’s GM labeling law is July 1, 2016.  As covered previously on this blog, although the food industry hoped that Congress would pass a federal bill preempting GM labeling laws by the states or would include a federal GM labeling fix in the omnibus bill, these hopes were not realized.  Absent a federal legislative solution or a victory in the food industry legal challenge (led by Grocery Manufacturers Association (GMA)) to the Vermont law in federal court, the food industry must decide how to comply with the new GM labeling requirements in Vermont.
  • On January 7, 2016, Campbell Soup announced its support for mandatory labeling of products that may contain genetically modified organisms and proposed that the federal government provide a national standard for non-GMO claims made on food packaging.  While the company maintains its position that foods derived from genetically engineered crops (GE) are safe and are not nutritionally different from other foods, and that “GMOs and other technologies will play a crucial role in feeding the world”, Campbell has concluded that mandatory federal GMO labeling is the best solution in light of the patchwork of state regulation that has arisen in the absence of federal regulation.
  • Campbell is breaking with GMA and many of its peers in calling for mandatory federal GM labeling. Campbell will become one of the first major food companies that has publicly announced its intent to disclose the presence of GE ingredients in its products on a national level; Denise Morrison, Campbell’s President and CEO, estimates that about three-quarters of the company’s products currently contain ingredients derived from corn, canola, soybeans or sugar beets, the four largest GE crops.  Campbell intends to seek advice from USDA and FDA with regard to the language it may use in its labeling – advice that may have implications for the entire food industry.

FDA announces seizure of dietary supplements containing kratom.

  • FDA has many tools in its arsenal to protect the public from adulterated, misbranded, and/or dangerous food and dietary supplement products; these include the Agency’s inspection power and various enforcement authorities (e.g., Warning Letters, mandatory recall orders in class I situations, administrative detention, seizure, suspension of facility registration).  Under its administrative detention authority, FDA can detain a food or dietary supplement product if the Agency has reason to believe the product is adulterated or misbranded.  The Agency can keep detained products out of the marketplace for a maximum of 30 days while it determines whether to take further enforcement action, such as seizure.
  • Earlier this month, FDA administratively detained dietary supplement products containing “kratom” — a botanical substance from Southeast Asia that may pose a risk to public health and that has the potential for abuse when consumed.  On January 6, U.S. Marshals initiated a seizure of approximately 90,000 bottles of kratom-containing supplements.  The U.S. Department of Justice filed a complaint in federal court on FDA’s behalf, alleging — among other things — that supplements containing kratom are adulterated because there is insufficient information to provide reasonable assurance that these products do not present a significant or unreasonable risk of illness or injury.
  • FDA’s use of its administrative detention authority, followed quickly thereafter by product seizure, indicates the Agency’s willingness to take swift and highly-publicized enforcement action against supplements that may pose safety risks.

2015 Dietary Guidelines for Americans released.

  • Every five years, the U.S. Department of Health and Human Services (HHS) and the U.S. Department of Agriculture (USDA) release the Dietary Guidelines for Americans (DGA) — a set of recommendations based on up-to-date nutrition science that is intended to help the U.S. population make healthy food and beverage choices.
  • On January 7, 2016, the government released the 2015-2020 DGA.  Overall, the new DGA recommends a dietary pattern that includes a variety of fruits (especially whole fruits) and vegetables, grains (at least half of which should be whole grains), a variety of proteins, and oils.  The DGA also recommends limiting the intake of saturated fats and trans fats, added sugars, and sodium.  For the first time, the DGA recommends capping added sugar intake at 10% of one’s daily caloric intake.  Despite continued controversy and highly-publicized evidence of carcinogenicity, the DGA does not recommend a specific limit on the consumption of red meat or processed meat.
  • Many expect the current guidelines to be controversial, as they contain recommendations that some view as outdated (such as the continued recommendation of low- and non-fat dairy products) and they omit recommendations that others believe are warranted (such as an express limit on red or processed meat or recommendations that take sustainability into account).

Federal government bans microbeads.

  • Microbeads are tiny beads of plastic added to cosmetics and personal care products to serve an abrasive or exfoliating function.  For years, environmental groups have expressed concerns that microbeads pollute waterways and pose harm to aquatic life because their small size allows them to pass through wastewater treatment systems in significant quantities.  In response to these concerns, several states enacted microbead bans, and many other states have been considering similar legislation.
  • In late December 2015, Congress passed the Microbead-Free Waters Act of 2015, which amends the Federal Food, Drug, and Cosmetic Act to ban the manufacturing and distribution of rinse-off cosmetics (including toothpastes) that contain intentionally added plastic microbeads.  The manufacturing ban will take effect on July 1, 2017, while the ban on distribution will take effect on July 1, 2018.  The effective dates are delayed by an additional year for microbeads in rinse-off cosmetics that are also nonprescription drugs.
  • The federal ban is supported by environmental groups and the plastics industry alike, and it puts an end to years of debate and the increasing development of a patchwork of state and local restrictions in this area.

FDA bans three chemicals used in the production of paper and paperboard.

  • FDA regulates the use of so-called “indirect” food additives.  In general, these are substances that may come into contact with food as part of packaging or processing equipment, but are not intended to be added directly to food.  Many indirect additives are the subject of FDA regulatory clearances in 21 CFR Parts 175, 176, 177, and 178.
  • On January 4, 2016, FDA published a final rule amending the food additive regulations to no longer permit the use of three perfluoroalkyl ethyl containing food-contact substances (FCSs) as oil and water repellants for paper and paperboard for use in contact with aqueous and fatty foods because new data are available as to the toxicity of substances structurally similar to these compounds that demonstrate there is no longer a reasonable certainty of no harm from the food-contact use of these FCSs.  The Agency implemented the ban in response to a petition filed by the Natural Resources Defense Council, the Center for Food Safety, the Breast Cancer Fund, the Center for Environmental Health, Clean Water Action, the Center for Science in the Public Interest, Children’s Environmental Health Network, Environmental Working Group, and Improving Kids’ Environment.
  • The Society of the Plastics Industry (SPI), a leading trade association in the food-contact materials industry, has indicated that the three chemicals subject to FDA’s ban are no longer manufactured and have been replaced by newer alternative technologies in present-day food-contact materials.  SPI thus supports the removal of these substances from FDA regulations on the basis of abandonment.  The groups who filed the petition with FDA have indicated that they intend to file similar petitions requesting that the Agency remove the clearances associated with a number of FCSs.  Many of the future targets of these petitions are anticipated to be substances that are indeed safe and still used.  Industry will need to stay aware of the new petitions to respond to these challenges and to ensure that FDA has the relevant data it needs to make a science-based decision on the safety of these cleared materials.

Keller and Heckman LLP has extensive experience in the food-contact material area.  For more information on this area of our Food & Drug practice, please visit our newly redesigned PackagingLaw website by clicking here.

We welcome our readership back with a wrap-up of recent news items of interest:

  • Vermont authorizes independent organizations to provide “non-GM” verification
    • In anticipation of the upcoming July 1, 2016 effective date for Vermont’s GM labeling requirements, the state Attorney General has authorized two independent organizations to provide verification that food has not been knowingly or intentionally produced from or commingled with food or seed produced with genetic engineering.  The two qualified organizations are The Non GMO Project and NSF International’s Non-GMO True North Standard.  Food companies voluntarily may seek certifications from these entities to take advantage of a labeling exemption available for “food that has been verified as not having been produced with genetic engineering by an organization that the Attorney General has authorized to make such verification.”  This is not the only exemption available to food producers, but it provides one clear “out” for suppliers and processors willing to participate in third-party verification programs.  Although many industry stakeholders had hoped for a federal legislative “fix” to stop implementation of the Vermont GM labeling requirements, the timing of Congressional action (if any) in this area is uncertain.
  • FDA creates Office of Dietary Supplement Programs (ODSP)
    • FDA announced the creation of the Office of Dietary Supplement Programs (ODSP), elevating the program from its previous position as a division under the Office of Nutrition Labeling and Dietary Supplements.  Bob Durkin is serving as Acting Office Director while the Agency identifies permanent leadership for the new Office.   Reflecting the reorganization, ODSP’s former parent office will now be called the “Office of Nutrition and Food Labeling.”
  • Just Mayo can keep its name
    • After a legal challenge, an FDA Warning Letter, and months of controversy, FDA is permitting the brand, “Just Mayo” to keep its name and its logo, provided that the Company makes some labeling changes (e.g., increasing the size of the “egg-free” qualifier and prominently defining the word “just” to clarify that the product is not an exact replica of mayonnaise).  At issue was the fact that the name, “Just Mayo” represented products as standardized mayonnaise even though they did not meet the applicable standard identity.  The resolution of this particular case opens the door to future tests of FDA’s flexibility regarding the use of standardized product names as part of a company’s brand strategy.

Federal judge tosses final claim in tomato farm’s lawsuit against FDA. (subscription to Law360 required)

  • In June 2008, FDA mistakenly linked a multistate Salmonella outbreak to tomatoes and warned consumers about the potential dangers associated with the consumption of raw red tomatoes in New Mexico and Texas.  Federal and state officials struggled to track the actual source of the contamination, and in the meantime, numerous tomato growers across the southeastern states were affected by the negative publicity and uncertainty surrounding the safety of tomatoes.  FDA’s investigation ultimately would find that raw peppers grown in Mexico were responsible for this particular Salmonella outbreak.  Multiple tomato growers sued FDA to recoup their losses.  In one long-running case, a tomato farm sued FDA for defamation, unfair trade practices, unlawful taking, and negligence.  In 2012, a South Carolina federal judge dismissed first three claims, leaving open only the question of FDA’s negligence.
  • On December 16, the judge dismissed the negligence claim, ending the case against the Agency.  The farm had argued that FDA acted negligently in issuing an overbroad tomato “recall” despite the Agency’s failure to link the contamination event to any particular tomato.  FDA’s action and the ensuing negative publicity allegedly resulted in a loss of $15 million in the value of the farm’s tomato crop.
  • Although the judge did not provide any reasoning in his dismissal of the case, a prior ruling suggests that the negligence claim stemmed from alleged misrepresentation and was barred by the Federal Tort Claims Act (FTCA).  (The government generally is immune from suit, but has provided a limited waiver of that immunity in the FTCA).  This dismissal follows closely on the heels of the November 2015 dismissal of a lawsuit by another farm seeking to recover $11 million lost during the tomato recall.  The fate of the tomato cases highlights the uphill battle that regulated industry can face in trying to recoup losses that stem from negative publicity associated with foodborne illness outbreaks.

The Daily Intake is taking a holiday hiatus and will return on January 4, 2016.  We wish you a joyous holiday season and a happy new year.