California and New York legislators consider warning labels for soda.

  • Sugar has been in the news again recently, particularly as the federal government works to prepare the 2015 Dietary Guidelines for Americans and in light of FDA’s proposal to require a declaration of “added sugars” on the nutrition facts panel of packaged foods and beverages.
  • At the state level, legislators in California and New York have introduced bills to require warning labels on sweetened non-alcoholic beverages, indicating that the consumption of beverages with added sugars contributes to obesity, diabetes, and tooth decay.
  • California and New York localities previously have taken action against sugary drinks in the form of Berkeley’s effective soda tax and former NYC Mayor Bloomberg’s controversial (and failed) ban on sugary drinks.  Although it is well established that excess sugar consumption is inadvisable, it remains debatable whether restrictive initiatives such as bans, taxes, and warnings at the state and local level strike the optimal balance between public health and consumer choice.

Sweden takes the European Commission to the Court of Justice of the EU over endocrine disruptors.

  • The discussion over the establishment of science-based criteria for endocrine disruptors is ongoing in the EU. The European Commission is obliged under the biocide legislation and the plant protection products legislation to establish such criteria. The deadline for establishing said criteria under the biocide legislation (Article 5(3) of Regulation (EU) No 528/2012) expired on December 13th 2013. For that reason, Sweden had already decided in 2014 to take the European Commission to the Court of the EU for inaction.
  • In its application for a judgment, Sweden explained that it had asked the Commission to take action with regard to endocrine disruptors’ criteria. The European Commission is currently working on the issue. It conducted a public consultation and established an Endocrine Disrupters Expert Advisory Group that concluded its work in 2013. The legislation however has not yet been issued. The European Commission explained to the Members of the European Parliament (debate 9 March 2015) that the views on endocrine disruptors vary among scientists. For that reason, and because of the complexity of the issues, the European Commission is launching a scientific impact assessment on the subject.  In the meantime the Nordic Council of Ministers (a forum for the cooperation of ministers of Denmark, Finland, Iceland, Norway and Sweden) issued a report on the costs of the European Commission’s inaction with regard to endocrine disruptors.  On that basis Sweden decided to take the European Commission to the Court of Justice of the EU. According to recent press releases the Council of the EU and Denmark will support Sweden before the Court.
  • The definition of criteria for endocrine disruptors is an important issue for many stakeholders and involves much discussion. The European Commission expresses its full awareness of that fact, but underlines the lack of scientific consensus over the topic. The actions taken by the European Commission and the Court of Justice will be significant for the industry.

The European Parliament calls for calorie labeling of alcoholic beverages.

  • Nutrition labeling of alcoholic beverages with an alcohol content over 1,2 % is not mandatory in the EU under the labeling legislation (Regulation 1169/2011/EU). The same legislation requires that the European Commission adopts a report addressing whether alcoholic beverages should in future be covered by the requirement to provide information on the energy value. This report was due by December 13th 2014 and has never been published. The European Parliament in its resolution adopted March 31st, 2015 called for the Commission to adopt rules for calorie labeling of alcoholic beverages.
  • The topic of calorie labeling of alcoholic beverages is being discussed in the EU. The beer industry stated that in the absence of the European Commission’s report, it would provide the list of ingredients and the nutrition labeling of alcoholic beer on a voluntary basis. Also, the industry supported the European Parliament’s resolution adopted on March 31st, 2015 where the Parliament called for the calorie labeling of alcoholic beverages. The resolution was adopted by the Parliamentary Committee on Environment, Public Health and Food Safety. In the second half of April the resolution will be presented and voted on during the Plenary Session of the European Parliament. Also, on April 27th 2015 the Commission will respond to aParliamentary question on the matter.
  • The calorie labeling of alcoholic beverages is one of the implementing issues posed by the labeling legislation of the EU. The European Commission stated that it would not take much action with regard to the implementation of that particular labeling legislation in the near future. The industry and the European Parliament do not seem to be in favor of this position and opt for Commission action.

USDA sued over listing process for synthetic substances used in organic foods. (subscription to Law360 required)

  • The U.S. Department of Agriculture (USDA) administers the National Organic Program (NOP), which includes standards for “organic” food in the United States.  The use of synthetic substances generally is prohibited in organic foods, with the exception of specific materials that have been evaluated and added to a national list of allowed and prohibited substances.
  • On September 16, 2013, USDA published a notice in the Federal Register, indicating a change in its listing process for synthetic substances.  Prior to September 2013, synthetic materials were removed by default from the national list after a five-year “sunset” period, absent a specific vote to keep them on the list.  Post-September 2013, the new process permits synthetic materials to remain by default on the national list, absent a specific vote to remove them.  The Center for Food Safety and other groups have now sued USDA in a California federal court, asserting that USDA’s change in policy — which did not allow for public comment — violates the Administrative Procedure Act and the Organic Food Production Act.
  • The lawsuit raises important questions about administrative procedure and whether USDA’s change in procedures constitutes a standard adjustment of Agency process or a significant substantive rule.  Considering the size and sustained growth of the U.S. market for organic food, the disposition of this case will be of interest to a significant sector of the food industry and to consumers as well.

FDA proposes to exempt farms that sell directly to consumers from registration requirement.

  • Many requirements of the FDA Food Safety Modernization Act (FSMA) are linked to FDA’s facility registration requirement.  For instance, FDA registration is the key trigger for compliance with FSMA’s hazard analysis and risk-based preventive control (HARPC) requirements.
  • FDA has issued a proposed rule to amend and improve its food facility registration regulations.  The proposed rule would exempt from registration farms that only sell food directly to consumers (e.g., through roadside stands and farmers’ markets).
  • Although the novel aspect of the proposal applies only to farm-direct sales, it bears noting that FDA’s new rule would codify other FSMA requirements related to registration more generally, e.g., the requirement to include email addresses in the registration form, the biennial renewal requirement, and the requirement for facilities to expressly acknowledge that FDA is permitted to accept the facility in accordance with its existing legal authority.

Food safety advocates petition for removal of propyl paraben from food.

  • The fact that foods may be marketed in the U.S. on the basis of general recognition of safety, or “GRAS” status, has come under heavy attack by food safety advocates and consumer groups in recent years.  In particular, some groups object to the fact that food companies are permitted to self-determine the GRAS status of substances, without seeking FDA pre-review or concurrence.
  • The Environmental Working Group (EWG) has launched a petition and a social media campaign to seek the removal of propyl paraben from the U.S. food supply.  Although this substance is specifically listed as GRAS in FDA’s regulations, EWG argues that data developed and reviewed by scientists and European safety authorities have raised questions about potential reproductive toxicity.
  • Food safety advocates and consumer groups continue to grow in number and visibility as they pursue publicity campaigns that question the safety of food ingredients in the U.S.  It is difficult to predict which ingredients will show up on the watchdogs’ “hit lists,” as targets may include even ingredients that are formally approved or GRAS-listed by FDA.

Scientists question empirical validity of current salt consumption guidelines.

  • For decades, the federal government has advised the U.S. population to limit salt intake.  The current Dietary Guidelines for Americans (DGA) recommend limiting daily sodium intake to less than 2,300 mg for most individuals and to 1,500 mg to special populations, including children, older adults, and those with particular health risks and concerns (e.g., hypertension, diabetes).
  • The empirical basis of the “reduced salt” recommendation has become the subject of significant controversy, with many scientists citing the existence of limited evidence that observing recommended limits on sodium intake improves health outcomes.
  • For years, FDA has been publicizing the benefits of reduced sodium intake and many food companies have voluntarily committed to reducing salt in their products.  Particularly as government agencies work to finalize the 2015 DGA, it remains to be seen whether and how the government will address the existing debate over the value of salt reduction.  A change in the position could have a significant impact on the food industry’s current efforts to find palatable and viable replacements for sodium.

Beer producer sued over “Product of U.S.A.” claim on products purportedly made with imported hops. (subscription to Law360 required)

  • A product may bear a “Made in America”-type claim in accordance with federal guidelines where “all or virtually all” of the product is made in the U.S.A.  California’s “Made in America” standard is stricter, prohibiting such claims if any unit or part of the product has been entirely or substantially made outside of the U.S.A.
  • Plaintiffs have sued a major beer producer, alleging a violation of California law where products purportedly made with imported hops are labeled with the claim, “Product of U.S.A.”
  • Construed strictly, California’s “Made in America” standard could be interpreted to mean that not even raw materials (including perhaps precursor chemicals and processing aids) used in food production may be of foreign origin.  The disposition of this case (among others involving non-food products) will be significant for the food industry, particularly considering the complexity of modern food production and the global supply chain.

State AGs ask Congress to crack down on dietary supplements.

  • Earlier this year, New York’s Attorney General (AG) launched a probe into the dietary supplement industry, targeting major retailers for marketing allegedly misbranded products.  One major retailer, GNC, entered into a landmark settlement agreement with the NY AG, committing to implement stringent controls throughout its supply chain and in production.
  • Continuing to expand its push into a traditional federal regulatory area, the NY AG and 13 other state AGs have sent a letter to members of Congress requesting an investigation of the herbal supplement industry.  The letter criticizes FDA, citing the Agency’s awareness of alleged problems in the dietary supplement supply chain and its implicit failure to take appropriate enforcement action.
  • The AG letter raises additional questions about the future roles of Congress, FDA, the states, and industry itself in the regulation of the dietary supplement industry.  The NY AG’s probe has been mired in controversy from the start due to its lack of transparency and complete reliance on DNA barcoding as the apparent “gold standard” for assuring the identity and purity of herbal ingredients, despite significant scientific criticisms of the methodology when applied to herbal ingredients.  It remains to be seen whether and how issues of science, law, policy, and regulation will be resolved in this matter, and how the dietary supplement industry will adapt and cope with the changes ahead.
FDA announces pending withdrawal of arsenic-based drug approved for use in food animals.

  • FDA regulates the use of animal drugs used in companion animals and food-producing animals.
  • FDA has announced its receipt of a letter of commitment from the manufacturer of the last arsenic-based animal drug currently approved for use in food animals, namely poultry.  Although the drug is based on organic arsenic — the less toxic form of arsenic — scientific data indicate that even this form could transform into inorganic arsenic, which is a known carcinogen.  FDA has analyzed tissue from treated poultry and found the presence of inorganic arsenic at higher levels than in untreated poultry.  The drug manufacturer has pledged to suspend sale of the drug this Fall and to formally request FDA withdrawal of the drug’s approval by the end of the year.
  • This action — just like the FDA-industry voluntary effort to phase out the use of medically important antibiotics for enhanced food production — highlights the potential for voluntary industry action to effectuate regulatory change without the need for formal agency action.

Senators criticize FDA for inadequate pet protections.

  • FDA oversees the safety of animal feed and pet food in the U.S.  Due to some idiosyncrasies in the animal food regulatory framework, FDA shares its pet food oversight responsibilities with state regulatory officials and the Association of American Feed Control Officials (AAFCO).  FDA has been tasked with implementing specific pet protection measures under the Food and Drug Administration Amendments Act of 2007 (FDAAA).  Enacted in response to the largest pet food recall in U.S. history (linked to melamine-contaminated ingredients from China), Title X of the FDAAA required FDA to establish standards for pet food ingredients and processing, to create an early warning and surveillance system to track outbreaks of illness associated with pet food, and to provide for better communications during pet food recalls.  Thus far, FDA has largely failed to implement these requirements.
  • Senators Dianne Feinstein (D-CA) and Richard Durbin (D-IL) recently sent a letter to FDA Commissioner, Margaret Hamburg, criticizing the Agency’s failure to take enforcement action related to recent reports alleging toxicity of a major pet food manufacturer’s product line,  The Senators also criticized FDA’s failure to implement its FDAAA pet protection mandates more generally.
  • The Senators’ letter is dated March 11, 2015.  On March 27, 2015, FDA announced its new strategy to standardize animal food ingredients in accordance with its FDAAA mandate.  Although FDA’s strategy likely has been under development for some time, the timing of the Agency’s announcement relative to the Senators’ letter raises questions about whether political pressure will finally spur FDA to act on its other long-overdue pet protection mandates.