My colleague Anne Glazer recently co-authored an article with Connie Kirby of Northwest Food Processors Association titled “Summary of Regulatory Intersection between the Federal Trade Commission and the Food and Drug Administration over the Labeling and Advertising of Food Products: Implication for Genetically Engineered Foods.”
Prepared for Oregon Governor Kitzhaber’s Task Force on Genetically-Engineered Agriculture, of which Connie is a member, the article provides a helpful summary of the jurisdictional arrangements and regulatory approach to GMO labeling by the federal agencies charged with regulating food product manufacturing. It also provides an excellent breakdown of the recent U.S. Supreme Court decision in POM Wonderful, LLC v. The Coca-Cola Company, which paved the way for a new battleground in food and beverage labeling litigation: competitor-to-competitor lawsuits.
Readers can download a PDF copy of the article here.
Also a quick shout-out to Connie Kirby and her fellow bloggers on their new “NWFPA Issues Blog.” NWFPA members can follow their commentary on the recent decision in POM Wonderful and other current topics relevant to the food industry at http://www.nwfpa.org/resources/issues-blog.
Nearly a year ago on August 5, 2013, we reported on the blog that the Food and Drug Administration (FDA) had published a final rule establishing a regulatory definition of the term “gluten-free” for voluntary use in the labeling of foods. The final rule is intended to provide a uniform definition of the term “gluten-free” so that consumers, particularly those who have celiac disease, will know what it means when they see it on the labeling of food.
The rule became binding and effective on September 4, 2013, but August 5, 2014 is the date when FDA-regulated foods labeled “gluten-free” must comply with all requirements established by the final rule. In preparation of the upcoming compliance date, FDA prepared a Small Entity Compliance Guide which restates in plain language the requirements concerning use of the term “gluten-free” in the labeling of foods.
Specifically, the guidance states that any label claiming that a food is “gluten-free” must not contain any of the following ingredients:
- An ingredient that is a gluten-containing grain (such as wheat, rye, or barley or any of their crossbreeds); or
- An ingredient that is made from a gluten-containing grain and that has not been processed to remove gluten. For example, “wheat flour” is an ingredient made from wheat that has not been processed to remove the naturally occurring gluten in wheat. Therefore, wheat flour cannot be used as an ingredient to make a food labeled “gluten-free;” or
- An ingredient that is made from a gluten-containing grain and that has been processed to remove gluten, if the use of that ingredient contains 20 parts per million (ppm) or more gluten.
The claim can also appear on the labels of foods that inherently do not contain gluten, such as fresh vegetables or juices.Continue Reading...
In a lawsuit filed yesterday, June 12, 2014, in United States District Court for the District of Vermont, four national trade associations representing food producers and manufacturers sued the state of Vermont claiming that the state’s recently passed Act 120, which would require certain food containing ingredients derived from genetically engineered crops to be labeled as such, violates the United States Constitution.
Enacted on May 8, 2014, Act 120 amends Title 9 of the Vermont Statutes to include a new chapter 82A, “Labeling of Food Produced with Genetic Engineering.” The new law requires food that is intended for human consumption and that is offered for sale on or after July 1, 2016 to be labeled as produced from genetic engineering if the food was entirely or partially produced with genetic engineering.
The act also prohibits a manufacturer of a food produced entirely or in part from genetic engineering from labeling the product on the package, in signage, or in advertising as “natural,” “naturally made,” “naturally grown,” “all natural,” or any other similar words. Most importantly, though, unlike other recently passed GMO labeling laws in Connecticut and Maine, Vermont’s law does not require passage of similar laws by other states in order to take effect. It is the first “no-strings-attached” GMO labeling bill to pass in any state.Continue Reading...
Last week U.S. Representatives Mike Pompeo (R-KS) and G.K. Butterfield (D-NC) introduced a bipartisan bill that would amend the Federal Food, Drug, and Cosmetic Act with respect to foods produced from, containing, or consisting of a bioengineered organism. The result has been either applause or outrage depending on which side of the GMO labeling debate you find yourself on.
Titled the “Safe and Accurate Food Labeling Act of 2014,” the bill, if passed, would establish a federal labeling standard for foods with genetically modified ingredients and give sole authority to the Food and Drug Administration (FDA) to require mandatory labeling on such foods if they are found to be unsafe or materially different from foods produced without genetically modified ingredients.
Specifically, the bill provides that biotechnology companies developing genetically modified ingredients for use in food products must submit a premarket approval notification to the FDA at least 210 days before the bioengineered organism is first introduced into interstate commerce. The premarket approval process outlined by the bill looks quite similar to the GRAS Notice Program currently in place for food additives.Continue Reading...
The Nutrition Facts panel found on many food packages, that most of us have been scanning in grocery aisles for the past 20 years, is expected to undergo some significant changes starting this week. According to a recent press release from the U.S. Food and Drug Administration (FDA), the agency is planning to update the Nutrition Facts label based on the latest science-based nutrition recommendations.
Sources indicate that the changes may be announced as soon as this Thursday, when First Lady Michelle Obama is scheduled to speak at the fourth anniversary celebration of the “Let’s Move!” campaign. Bookmark this site for our report once the proposed Nutrition Facts changes are announced.
By way of background, the Nutrition Facts panel has allowed consumers to have consistent nutritional information and to make healthier choices, since passage of the Nutrition Labeling and Education Act of 1990 mandated nutrition labeling. In addition, throughout the years, mandatory nutrition labeling has encouraged many companies to change their ingredients to make the foods more healthful and thus more appealing to many consumers.
However, in light of new knowledge about nutrition and more evidence that people actually consult the labels of food packages, FDA officials believe it is time for an overhaul. Paula Trumbo, Ph.D., acting director of FDA’s nutrition programs staff explains that “updates are currently being assessed to address such factors as current nutrient recommendations, public health concerns based on recent data on food consumption, and the agency’s desire to make this information as clear and useful as possible.”
From labor and employment attorney Alyson Palmer:
The U.S. Occupational Safety and Health Administration (OSHA) published an interim final rule on February 13, 2014, creating the process for handling retaliation complaints brought by whistleblowers under Section 402 of the Food Safety Modernization Act (FSMA). Section 402 of FSMA amended the Federal Food, Drug, and Cosmetic Act to add Section 1012, 21 U.S.C. 399d, which provides protection for employees “engaged in the manufacture, processing, packing, transporting, distribution, reception, holding, or importation of food” who report a violation of the Act, testify against, or otherwise participate in a proceeding related to a violation.
Prior to the passage of FSMA on January 4, 2011, there was no federal whistleblower protection in the food safety arena. Accordingly, food industry employees were dependent upon state wrongful discharge laws for relief. Now, any employee who submits a complaint indicating a violation of FSMA or any FDA regulation or order is protected from any form of adverse employment action or harassment based in whole or in part on such a complaint.Continue Reading...
On August 29, 2012, the Center for Food Safety (CFS) and the Center for Environmental Health filed an action against the U.S. Food and Drug Administration (FDA) alleging that the agency had violated the Food Safety Modernization Act (FSMA) and the Administrative Procedure Act (APA) by unlawfully withholding FSMA regulations beyond the required statutory deadlines. The plaintiffs sought declaratory and injunctive relief requiring FDA to issue the regulations pursuant to a court-ordered timeline.
Yesterday, the U.S. District Court for the Northern District of California issued a consent decree whereby the parties agreed to extend and stagger the final rule deadlines beyond the June 2015 deadline initially set by the court last year. In exchange, the FDA has agreed to drop its Ninth Circuit appeal in the dispute with the two consumer advocacy groups.
The regulations required under FSMA were originally scheduled to be promulgated in 2012. However, due to significant delays and budgetary concerns, the FDA failed to meet those deadlines which prompted CFS to file its lawsuit.
According to the consent decree, the new deadlines are as follows:
|Preventive controls for human food||August 30, 2015|
|Preventive controls for animal food||August 30, 2015|
Produce safety standards
|October 31, 2015|
|Foreign Supplier Verification Program||October 31, 2015|
|Accreditation of third-party auditors||October 31, 2015|
|Sanitary transportation of food||March 31, 2016|
|Intentional adulteration/food defense||May 31, 2016|
The FDA agreed “in good faith” to issue the final rules by the above deadlines. The dates provided are dates by which FDA will submit the final rule to the Federal Register for publication, rather than the dates by which the final rule will be published. However, the ruling permits FDA to seek further extensions of any of the above deadlines through written agreement of the parties and notice to the court if the agency believes in good faith that it cannot meet them. If the parties are unable to agree on an extension, FDA may seek an extension by filing a motion with the court. FDA would have the burden to prove “good cause and/or exceptional circumstances warranting the delay, and address the effect of the delay on the public health and safety.”
While standing in front of a tractor at Michigan State University (the first land-grant university) on Friday, February 7, 2014, President Obama signed the long awaited $956 billion farm bill into law. The 2014 Farm Bill, what some have called a “jobs bill,” an “innovation bill,” a “research bill” and a “conservation bill,” passed in the House on January 29, 2014 with a vote of 251 to 166. The new five-year farm bill later advanced toward final passage on Tuesday, February 4, 2014 after a strong bipartisan Senate vote. According to FarmPolicy.com, “Lawmakers passed the sprawling legislation this week after four years of bitter arguments over farming subsidies and Republican efforts to reduce financing for food stamps. The final 950-page bill replaces direct crop payments with an insurance program and trims $8 billion from food stamps over the next decade.”
The farm bill is a massive piece of omnibus legislation that tends to make headlines every five to seven years when it is renewed by Congress. The first farm bill, the Agricultural Adjustment Act of 1933, was originally developed under President Franklin Delano Roosevelt’s New Deal as an emergency measure for farmers during the Great Depression to address plummeting commodity crop prices. During that time, the law essentially paid farmers to not grow food on a certain percentage of their land in order to prevent overproduction and balance supply and demand. In addition, the federal government bought and stored large quantities of grain in order to stabilize crop prices. The early law also included a nutrition program — the precursor for the supplemental nutrition assistance program (SNAP) — to feed the hungry.
Since then, agriculture in the U.S. as well as government policies concerning agriculture have changed dramatically. Yet despite these changes, the government continues to play a major role in managing risks within the agricultural industry. The modern day farm bill now addresses a wide variety of issues including nationwide hunger, rural broadband service, soil erosion, lack of credit and unfair export practices. For instance, the 2008 Farm Bill contained 15 distinct titles, including Commodities, Conservation, Trade, Nutrition, Rural Development, and Energy, among others.Continue Reading...
The U.S. Food and Drug Administration (FDA) issued its proposed rule on sanitary transportation under the Food Safety Modernization Act (FSMA) that would require certain shippers, receivers, and carriers who transport food by motor or rail vehicles to take steps to prevent the contamination of human and animal food during transportation. The proposed “Sanitary Transportation of Human and Animal Food” rule, the seventh and final major rule central to the food safety framework under FSMA was published in the Federal Register on February 5, and will remain open for public comment through May 31, 2014.
Over the past few decades, there have been reports of foodborne illness outbreaks due to food products becoming contaminated during transportation as a result of insanitary transportation practices. In 2009, an FDA research group identified several areas where food may be at risk for physical, chemical, or biological contamination during transport and storage, including:
- Improper refrigeration or temperature control;
- Improper packing of transportation units or storage facilities;
- Improper loading and unloading practices, conditions, or equipment;
- Poor pest control in transportation units or storage facilities;
- Lack of training and/or knowledge of food safety issues;
- Poor transportation unit design and construction;
- Inadequate maintenance for transportation units or storage facilities, resulting in roof leaks, gaps in doors, and dripping condensation or ice accumulations;
- Poor employee hygiene;
- Inadequate policies for the safe and/or secure transport or storage of foods;
- Improper handling and tracking of rejected products; and
- Improper holding practices for food products awaiting shipment or inspection.
Despite reports of unsanitary transportation practices, FDA deputy commissioner for foods and veterinary medicine Michael Taylor explained that the likelihood of contracting an illness caused by these practices is slim. He recently wrote on the FDA’s blog, “Truthfully, it’s uncommon for a foodborne illness to be caused by contamination during transportation. But we have received reports of unsanitary practices, and we want to minimize this potential source of illness.”Continue Reading...
Alternative Product Labeling: Will "Simply" Changing Your Brand Protect Your Company From False Advertising Claims?
For the past few years, there has been a steady, if not increasing, stream of class action lawsuits filed against various food and beverage manufacturers and retailers alleging misbranding and false advertising due to the presence of “All Natural” claims. The companies sued in these cases range from major manufacturers and retailers to small private label suppliers. Typically, these consumer class actions typically allege that the products are falsely marketed as “natural” because they contain synthetic, artificial or processed ingredients. Products that bear an “All Natural” claim but contain ingredients anywhere from ascorbic acid (vitamin C) to zinc oxide have been challenged on false advertising grounds.
In light of the risk of litigation around the use of “All Natural” claims, some companies have begun reassessing statements and claims on their product labels and are taking a new approach to their marketing and advertising. One such company is PepsiCo. Recently, the company changed its “Simply Natural” line of Frito-Lay chips to just “Simply,” and its “Natural Quaker Granola” is now marketed as “Simply Quaker Granola.” Other large food companies, like Ben & Jerry’s, Breyers, and Campbell Soup Company, have also dropped the word “natural” from its new packaging.
However, replacing the word “natural” with a word like “simply” may not necessarily be a safe harbor. In 2003, the Center for Science in the Public Interest (CSPI) petitioned the Food and Drug Administration (FDA) to take regulatory action to prohibit The J.M. Smucker Company from making deceptive and misleading labeling claims that misrepresent the amount of fruit in Smucker’s “Simply 100% Fruit” spreadable fruit products. CSPI argued that the products contained more fruit syrup than fruit and that the syrups were actually made from apple and pineapple juice rather than the fruit named on the principal display panel.
In order to stave off litigation, food and beverage companies should carefully evaluate the claims of their product labels. For instance, is it worth the risk to use the work “natural” in product labeling and advertising? According to Stoel Rives attorney Melissa Jones, a trial lawyer who frequently counsels food and beverage companies faced with “All Natural” false advertising claims, it might not be. Melissa writes:
Although a few of the “All Natural” class action lawsuits have been dismissed at an early stage of the litigation, most courts have been unwilling to grant motions to dismiss entire cases and at least some of the claims usually proceed to further litigation or are resolved through settlement. The expense to companies that are sued in these cases is, not surprisingly, substantial, with settlements requiring payments of several million dollars.
That said, the alternative to “natural” labeling, such as the use of a word like “simply,” might not be litigation-proof either. Companies should conduct an intensive review of product ingredients to ensure compliance with labeling regulations and determine whether the ingredients and labeling claims are likely to result in an unwanted lawsuit.