Category Archives: Genetically Modified Organisms

Congress Passes GMO Labeling Bill, President Obama To Sign into Law

On July 14th, Congress passed a GMO labeling bill by a vote of 306-117 that would preempt Vermont’s mandatory labeling act that went into effect on July 1st.  The White House said President Obama will sign the bill into law.

Under the legislation, explicit labeling of GMO ingredients is voluntary and companies are allowed to instead use a computer-generated QR (quick response) code to identify GMO ingredients.  Consumers can scan the QR code with a smartphone which takes them to a website to find out if a product includes GMOs ingredients.  The Organic Trade Association, which has supported mandatory labeling, supported the bill because, among other things, it includes a provision allowing organic food companies to label their products as non-GMO.

Notably, the FDA has stated that if modified genes are removed in the manufacturing process ― which can happen with ingredients such as corn syrup and canola oil ― there is no requirement for notification under the law.  But the Agriculture Department, which would oversee GMO labeling under the law, apparently disagrees with that interpretation.  Accordingly, many believe the scope of ingredients requiring notification under the new law might ultimately be decided by courts.

Republicans and Congresspersons from rural states strongly supported the legislation. “The clock has run out, my producers need certainty and an interstate commerce nightmare will shortly ensure if we don’t pass this bill,” said Rep. Rodney Davis, R-Ill.

GMA States it will Challenge Vermont GMO-Labeling Bill

On May 8th, Vermont Governor Peter Shumlin signed into law the nation’s first GMO labeling law requiring that food offered for retail sale that is entirely or partially produced with genetic engineering must be labeled as such by July 2016.  Ballot initiatives to require GMO labeling failed in California and Washington while Maine and Connecticut passed laws that do not go into effect until other states pass GMO-labeling laws.

The Grocery Manufacturers’ Association (GMA) has already announced plans to challenge the new law, stating in relevant part:

Today, Vermont Governor Peter Shumlin signed into law HB 112, a bill that is critically flawed and not in the best interests of consumers.  It sets the nation on a costly and misguided path toward a 50-state patchwork of GMO labeling policies that will do nothing to advance the safety of consumers.

GM crops are safe and have important benefits for people and our planet.  They use less water and fewer pesticides, reduce crop prices by 15-30 percent and can help us feed a growing global population of seven billion people.  ….

Consumers who prefer to avoid GM ingredients have the option to choose from an array of products already in the marketplace labeled ‘certified organic.’ The government therefore has no compelling interest in warning consumers about foods containing GM ingredients, making this law’s legality suspect at best.  In light of this fact, in the coming weeks GMA will file suit in federal court against the state of Vermont to overturn the law.

See the GMA’s complete press release here.

Consumer’s right to know or compelled speech that violates the First Amendment?  The final answer to this compelling question is still many years away.

FDA Declines Courts’ Requests to Determine if GMO’s Allowed in “Natural” Products

The FDA has declined the referral requests from three U.S. District Courts seeking to have the FDA pronounce on whether “GMO ingredients may be used on food products labeled as “natural” or “all natural.”   The three cases are Cox v. Gruma Corp., 4:12-cv-6502 (N.D. Cal.), Barnes v. Campbell Soup Co. 3:12-cv-05185 (N.D. Cal.) and In Re General Mills, Inc. Kix Cereal Litigation, 2:12-cv-00249 (D. N.J.).

The FDA explained its rationale as follows in a January 6, 2014 letter to the three relevant judges signed by Leslie Kux, Assistant Commissioner for Policy:

FDA has not promulgated a formal definition of the term “natural” with respect to foods.  The agency has, however, stated that its policy regarding the use of the term “natural” on food labeling means that “nothing artificial or synthetic (including all color additives regardless of source) has been included in, or has been added to, a food that would normally be expected to be in the food.”   See 58 Fed. Reg. 2302, 2407 (1993).

If FDA were inclined to revoke, amend, or add to this policy, we would likely embark on a public process, such as issuing a regulation or formal guidance, in order to determine whether to make such a change; we would not do so in the context of litigation between private parties.  Issuance of a regulation or guidance document allows an agency to obtain data, information, and views from all stakeholders wishing to engage on an issue.  ….
 [In addition,] [a]ny definition of “natural” on food labeling has implications well beyond the the narrow scope of genetically engineered food ingredients about which the Court’s referral pertains.   For example, if the agencies were to define the term, they would likely need to consider among other things: relevant science; consumer preferences, perceptions, and beliefs; the vast array of modern food production technologies in addition to genetic engineering (e.g., use of different types of fertilizer, growth promotion drugs, animal husbandry methods); the myriad food processing methods (e.g., nanotechnology, thermal technologies, pasteurization, irradiation); and any strictures flowing from the First Amendment.  Thus, even if we were to embark on a public process to define “natural” in the context of food labeling, there is no assurance that we would revoke, amend, or add to the current policy, or develop any definition at all.
In other words, the FDA is keenly aware that an effort to craft a comprehensive definition of “natural” necessarily opens the door to an array of issues and interest groups that would complicate an already complex process.  Thus, the FDA concluded by observing that its current priorities are public health and safety matters, including developing regulations relating to the Food Safety and Modernization Act and the Patient Protection and Affordable Health Care Act.
The FDA’s response is not necessarily a rejection of the GMA’s recent request to have the FDA define natural (as set forth in my prior post).   Rather, the FDA is noting to these courts that the rule-making process would take years, that it is not inclined to start that process now, and that it would not engage in this process in the context of litigation.

GMA Encourages FDA to Act on Labeling of GMO Ingredients as “Natural”

I previously wrote about two U.S. District Courts which stayed class action suits targeting “all natural” claims in light of the primary jurisdiction doctrine.  See here and here.  Both courts deferred to the FDA’s “unique expertise and resources suited to resolving the issues presented by Plaintiff’s claims,” i.e., whether use of GMO ingredients precludes any use of “all natural” claims.  The cases were stayed for six months with the potential for additional extensions of time based on good cause, including an indication from the FDA that it intends to resolve this issue.

Two other courts, however, rejected this approach because, in part, “various parties have repeatedly asked the FDA to rule on “natural” labeling, and the FDA has declined to do so because of its limited resources and preference to focus on other priorities.”  See here.

The Grocery Manufacturers Association (GMA) is now urging the FDA to move forward and resolve the issue as requested  by the two U.S. District Courts.  In a letter dated December 5, 2013, the GMA asked the FDA, in light of the district court referrals, to “actively address this question through the rule making process” which will “bring uniformity and consistency to both consumers and food manufacturers.”  In addition, the GMA noted:

GMA’s members have a strong interest in “natural” labeling for foods containing ingredients derived from biotechnology.  Several of the most common ingredients derived from biotechnology are  from crops such as soy, corn, canola, and sugar beets.  There are 26 state legislatures considering whether foods containing ingredients derived from biotechnology should be labeled and whether they are permissible in “natural” foods.  Moreover, there are approximately 65 class action lawsuits that have been filed against food manufacturers over whether foods with ingredients allegedly derived from biotechnology can be labeled “natural.”  Given the predominant use of crops derived from biotechnology in our economy as well as consumer and state interest in this issue, whether foods that contain ingredients derived from biotechnology can be labeled “natural” is an important matter to GMA members and is one that warrants FDA’s involvement.

See the complete GMA letter here and its separate website The Facts About GMOs.

The FDA’s request comes on the heels of a letter from the Center for Food Safety to the FDA which provided a contrary view.  Notably, the Center for Food Safety’s chief concern that the FDA might define “the term ‘natural’ for use on food labels in an ad hoc, fact-specific, and haphazard manner, per individual court request, lacking public process and general applicability.”  It then requested basically the same relief sought by the GMA – that the FDA “should address this issue by defining “natural” through the rulemaking process provided for by the Administrative Procedure Act (APA), which requires that the agency provide notice of proposed rulemaking and an opportunity for the public to comment.”  It added:

In the alternative, if FDA does choose to act in the context of litigation, we urge FDA to define “natural” in a way that prohibits the labeling of any food as “natural” that was produced in whole or in part through the process of genetic engineering or that contains ingredients derived from genetically engineered organisms.

The Center for Food Safety states that it represents the “food movement” and, in a press release issued after the GMA’s letter, added:

There is nothing natural about genetic engineering, which is exactly why the Grocery Manufacturers Association wants FDA to create a special exemption for it.  Natural is a great marketing tool and the industry doesn’t want to be restricted in using it. FDA should not respond to GMA’s demands for a special GMO loophole. FDA has a duty to protect consumers, not industry.

Time will tell whether the FDA decides to accept the district court referrals, but color me doubtful.

After Busy 2013, FDA Has More Goals for 2014 Including Nutrition Facts, Menu Labeling and GMO Labeling

At this time of year, it’s worthwhile reviewing the 2013-2014 plan  of the FDA’s Center for Food Safety and Applied Nutrition, which was updated this past September.  Key targets for the new year include menu labeling and nutrition facts.  There is reason to pay close attention given the FDA’s busy 2013.  It tackled trans fats and defined “Gluten free” while also implementing major rules for the Food Safety & Modernization Act.  Based on the FDA’s stated priorities in its plan 2014 shapes up to be just as busy.

In the 2013-2014 plan, Program Goal 4 is to “Improve public health indicators through better nutrition and dietary choices” which includes “implement[ing] science-based strategies that encourage consumers to choose healthy diets.”  Specific goals grouped under these broader goals include the following:

  • 4.1.6:  Develop for publication in 2015 final rules to update nutrition facts label and serving size information to improve consumer understanding and use of nutrition information on food labels.
  • 4.1.8:  Publish final rules for requiring nutrition information on menus and on vending machines.
  • 4.1.11: Publish final guidance to help manufacturers who wish to voluntarily label their foods as being made with or without the use of bioengineered ingredients.

All of these have target dates of 2014 except for voluntary GMO labeling, which was listed as 2013 but has not yet been implemented.

Nutrition Facts:  Proposed changes are expected in “early 2014.”   The details of potential changes will impact serving size and label format, with other potential modifications relating to daily values and additional nutrient declarations.

Menu Labeling: This initiative is borne out of the Affordable Health Care Act and will require restaurants with 20 or more locations to disclose the amount of calories in their food.  Although final guidance was slated for 2013, it looks like it will not arrive until 2014 due to continued obstacles to its implementation.  The delay is primarily due to proposed legislation and debate over whether these requirements should apply to grocery stores and pizza chains, both of which complain that it is not possible or unduly burdensome to meet the labeling requirements.

GMO Labeling:  Notably, FDA guidance has the potential to preempt state laws requiring mandatory labeling of GMOs.   In other words, guidance on voluntary labeling might preclude local efforts to mandate labeling of GMOs.  On the other hand, inconsistent court or jury rulings is not helpful either.  FDA chief Margaret Hamburg said in early November that the regulations would be finalized “soon” without any further elaboration.

Finally, Goal 4 includes “Reduce sodium and industrially-produced trans fat in the food supply” which includes, for 2014,”[c]omplete a plan for implementation in 2015 to promote broad, gradual reduction of added sodium in the food supply.”  It remains unclear how the FDA intends to implement this proposed reduction which is significantly different than its recent effort to eliminate trans fats.

Update: Washington Voters Say No to GMO Labeling

See Seattle Times report here.

Voters to Decide Fate of Washington’s GMO Labeling Ballot Initiative

Tomorrow is election day in Washington State with ballot initiative 522 being the new focus of the GMO labeling debate.  The initiative would require food products with GMO’s to be labeled beginning July 1, 2015, for sale at retail.  Exemptions exist for alcoholic beverages, food sold in restaurants and milk and meat from animals that ate GMO feed.  The Seattle Times has excellent “Pro” and “Con” articles on this issue.   Please take a read.