Moving Forward with Food

The new year brings additional regulations, legislation and litigation for food producers and distributors. The food industry should be aware of and prepared to respond to new Food Safety Modernization Act (FSMA) regulations, a continued push for legislation requiring the labeling of genetically engineered food and an influx of new consumer fraud class actions directed at product labeling.

Food Regulation

On the second anniversary of the signing of the FSMA, FDA announced long-awaited proposed regulations on preventive controls for human food and proposed standards for produce safety. The Current Good Manufacturing Practice (cGMP) and Hazard Analysis and Risk-Based Preventive Controls will implement FSMA section 418, which addresses preventive controls and modernizes current cGMPs.

The preventive-controls regulations form much of the backbone of FSMA. These rules require that under FSMA food facilities (a) analyze potential hazards associated with their facilities, (b) develop and implement controls to significantly minimize or prevent those hazards, (c) verify the controls are working (and take corrective action if they are not) and (d) periodically reassess those hazards and controls.

FDA has indicated that it will work to develop a training curriculum once the final rule has been released. In addition, FDA will release a guidance document to help businesses comply with these new requirements.

The Standards for the Growing, Harvesting, Packing and Holding of Produce Proposed Rules for Preventive Controls for Human Food implements FSMA section 419, which requires that FDA publish minimum standards for the safe production and harvesting of fruits and vegetables. They apply only to farms that grow, harvest, pack or hold produce in a raw or unprocessed state. Some farms would not be covered by the rule, or would be eligible for a partial exemption based on the amount of food sales and to whom they sell.

The produce safety standards focus on major areas in which microbiological hazards might be introduced: (1) employee hygiene, (2) agricultural water, (3) soil amendments, (4) animal incursion and (5) equipment, tools and buildings. This rule would target products and practices in which FDA believes intervention will be most successful to reduce risks. Therefore, the rule would provide a number of exemptions, including for foods that are rarely consumed raw (artichokes, asparagus, beets, cranberries, potatoes and sweet corn), and produce that receives a kill step (such as canning, commercial processing or refining). These standards build on FDA’s preexisting commodity-specific guidance, as well as science-based industry practices and standards.

Comments on the rules are due May 16. FDA also will hold a number of public hearings to explain the rules and provide another opportunity for input from industry and stakeholders. FDA’s current prediction is that the notice and comment period, public meetings and subsequent FDA deliberation and decision-making will take at least a year. Industry can most likely expect to see final rules published sometime in 2014, with an effective date 60 days after that. Most companies will have one year to comply. Small businesses employing fewer than 500 persons will have two years to comply and very small businesses – their size is still to be defined – will have three years to comply with modified requirements.

There are three additional regulations that FDA has already drafted that are expected to be released in the near future: preventive control regulations for feed and pet food facilities, Foreign Supplier Verification Program (FSVP) regulations and accredited third-party certification regulations for imported foods and ingredients.

Food Legislation

In November, California voters rejected Proposition 37, which would have required labeling for some genetically engineered (GE) foods. Generally, upscale urban and coastal regions were in favor of the amendment while inland areas mostly rejected it. If California had passed Prop 37, it would have been the first state to pass GMO labeling legislation. Countries in the European Union – as well as Japan, Australia, New Zealand, Russia, India, China, Saudi Arabia and South Korea – are just a few of the nations that already require genetically engineered foods to be labeled.

The debate in the United States is not over. On Jan. 3, Washington state GE food-labeling advocates sent a petition to the secretary of state in hopes of passage by the state legislature or approval by voters next November. The petition contained 350,000 signatures, and only 241,153 validated signatures are required to qualify for the November 2013 ballot. The nearly 2,500-word People’s Right to Know Genetically Engineered Foods Act (I-522) is similar to California's proposition.

Beginning in 2015, any food offered for retail sale in Washington would be misbranded “if it is, or may have been, entirely or partly produced with genetic engineering and that fact is not disclosed.” Several of the proposed exemptions include processed foods produced with the aid of GE processing aids or with no more than 0.9 percent GE ingredients. Unlike Proposition 37, the Washington initiative doesn't prohibit the term “natural” on labels of products with GE ingredients.

Additionally, New Mexico Senate Bill 18 was pre-filed after California voters defeated Proposition 37. This bill defines genetically modified “material” as a “substance that has been produced, enhanced or otherwise modified through the use of recombinant deoxyribonucleic aid technology, genetic engineering or bioengineering.” The bill would require any product containing more than 1 percent of a genetically modified material to have the ingredient disclosed on the label. Under this proposal, companies that don’t properly label genetically modified items will be subject to penalties pertaining to misbranding. Clearly, the defeated California amendment might light the fire for further activism.

Food Litigation

In recent years, we have witnessed an explosion in consumer fraud putative class actions focused on whether use of the claims “natural,” “all-natural,” “100 percent natural” or similar terms on a food product’s label is false, misleading or deceptive. Initially, these suits largely were focused on food products containing high-fructose corn syrup that were labeled as “natural.” Other early targets included ice cream products containing alkalized cocoa, products containing trans fats and allegedly artificial citric acid.

In 2011 and 2012, these cases evolved to target not only allegedly artificial or synthetic ingredients, but also the process involved in making an ingredient or product. For example, plaintiffs have alleged that at-home smoothie kits include “unnaturally processed, synthetic and/or non-natural ingredients,” including ascorbic acid and xanthan gum. Other putative class actions have focused on the use of synthetic vitamins or fiber that allegedly are either not natural – because they were made using synthetic processes – or were produced in a way that makes them unnatural – such as allegations that beta carotene or fiber can naturally occur in foods, but some is made synthetically and then added to foods.

Look for “natural” litigation to continue expanding and evolving in 2013 as the plaintiffs’ bar continues its endeavors in challenging food labels. New complaints will make allegations against additional ingredients that sound “non-natural,” and plaintiffs may begin to look more closely at photographs, images and themes on labels, packaging and websites.

Sarah L. Brew (sarah. [email protected]) co-leads the food litigation and regulatory practice at the law firm Faegre Baker Daniels LLP.  Kiri Somermeyer  ([email protected]) and Steven B. Toeniskoetter ([email protected]) are associates in the firm’s food litigation and regulatory practice.

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