Regulatory Comments to Docket No. FDA-2000-D-0075, Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived From Genetically Engineered Plants; Guidance for Industry; Availability (80 Federal Reg 73194)Regulatory Comments to Docket No. FDA-2000-D-0075, Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived From Genetically Engineered Plants; Guidance for Industry; Availability (80 Federal Reg 73194)
Date: December 24, 2015
FDA has held a longstanding policy for using “natural” claims in food labeling, which it first articulated in 1991. FDA states that for foods to be called “natural”, nothing artificial or synthetic (including colors regardless of source) is included in, or has been added to, the product that would not normally be expected to be there. FDA, however, has never defined “natural,” nor has FDA established requirements through regulation for the use of “natural” in food labeling. In recent years, FDA has received a number of citizen petitions requesting that FDA define “natural,” and has received requests from federal courts asking it to respond to questions about “natural” claims being disputed in litigation.1 On November 12, 2015, in response to these inquiries, FDA finally published a notice in the Federal Register requesting public comments and other information on use of the term “natural” in food labeling, including when, if ever, the term would be false or misleading. FDA asked specifically for comments on: use of “natural” in the labeling of foods derived from GE; whether and how consumers associate the term “natural” with the terms “organic” or “healthy”; whether use of “natural” should be allowed only in the labeling of single ingredient foods; and other issues related to processing of foods and ingredients.
FDA’s history on the labeling of genetically engineered (GE) foods actually started nearly a quarter century ago. In 1992, FDA announced a policy indicating there were no specific labeling requirements for foods from bioengineered plants as these foods were not different in any meaningful way than their non-GE counterparts and there were no different or greater safety concerns with GE foods. In 2001, the FDA drafted guidance on labeling of GE goods, and received more than 150,000 comments on the drafted guidance. The agency has been silent on the topic until November 24, 2015.
FDA released two recent draft guidance documents regarding voluntary labeling of foods derived from genetically-engineered sources: “Draft Guidance for Industry: Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived from Genetically Engineered Plants” and “Draft Guidance for Industry: Voluntary Labeling Indicating Whether Food Has or Has Not Been Derived From Genetically Engineered Atlantic Salmon.” NPA understands that the Agency’s position on the labeling of genetically-engineered foods is unchanged from its initial 1992 policy statement. It is also our understanding that FDA believes that (1) there is no evidence that bioengineered-foods are materially different from, or pose higher safety risks than, other foods; and (2) food manufacturers may voluntarily label their foods with information about bioengineering, as long as that information is truthful and not misleading.
Key Elements in the Draft Guidance
What Are the Key Elements in the Draft Guidance
In the current announcement, the FDA is clear in providing guidance for those manufacturers who choose to voluntarily label their products. FDA also upholds their original stance that genetic engineering does not change the food in any meaningful way and that there are no different or greater safety concerns. NPA respects FDA as the leading authority on food safety and respectfully requests FDA to provide the safety studies which served as the basis for this assertion that there are no different or greater safety concerns in GE foods. The guidance document is also focused on providing guidance to ensure that those who choose to label GE ingredients or foods are consistent with the core tenant of food labeling which indicates all information must be “truthful and not misleading.” NPA found five key statements in your guidance.
- Avoidance of the term “genetically modified.” FDA indicated that modification in this content means the alteration of a plant’s genetic composition from adding, deleting or changing hereditary traits, regardless of the method. This modification can occur through traditional hybridization or breeding techniques, and therefore, this term could apply to most cultivated food crops today. Instead, FDA recommended terms such as “not bioengineered,” “not genetically engineered,” or “not genetically modified through the use of modern biotechnology” be used on the label. Avoidance of GMO free, GE free, non-GMO and similar claims. The term free conveys total absence unless a regulatory definition has been put in place by the FDA. In light of the challenges of substantiating a free claim in this situation, FDA recommends that manufacturers avoid claims that indicate zero presence of ingredients derived through the use of biotechnology. Additionally, because the “O” in GMO refers to organism and most foods do not contain organisms, the FDA is recommending avoidance of this term.
- Ensure all label statements are not misleading. Labeling statements that highlight one ingredient not developed through GE while there is another ingredient in the food that was bioengineered would be considered misleading by the FDA. If a food label claims “none of the ingredients in this food is genetically engineered” when some ingredients cannot be produced through GE, this would also be considered misleading. If a label suggests a non-GE food is safer, more nutritious or has other benefits compared to the GE counterpart, this labeling could also be considered misleading.
- List common or usual names only in the ingredient declaration. Regulations for ingredient declarations clearly indicate there cannot be intervening material listed as per 21 CFR 101.2(e). To this end, “Non-GE” and other similar statements cannot be listed as a part of the ingredient name within the ingredient declaration. These types of statements, such as made from certified non-GE soybeans, are allowed on parts of the label outside of the ingredient declaration.
- Label differences if they exist. If a food derived from GE plants is significantly different or has significantly different nutrition from its traditional counterpart, the name of the new food must be changed to a term that accurately describes the new food or the label must describe the nutritional differences. An example would be oil with a different fatty acid profile derived through bioengineering. If a food derived through genetic engineering contains an allergen that consumers would not expect to be present in the food based on the name of the food, the presence of that allergen must be disclosed on the label, in accordance with the Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004.
Vermont Mandatory GE Labeling Law.
Vermont recently passed its own mandatory GE labeling law (Act 120), which will go into effect July 1, 2016. The state law establishes mandatory labeling and recordkeeping requirements that apply to all packaged foods that are produced with GE, as defined by that law, and offered for retail sale in Vermont. Primarily, unless an exemption applies, manufacturers must label GE foods as “Produced with Genetic Engineering” and cannot use many “natural” terms in labeling. More specifically, Act 120 prohibits GE manufacturers from labeling a product “in signage, or in advertising” as “natural,” “naturally made,” “naturally grown,” “all natural,” or “any words of similar import,” which are collectively termed Act 120’s ‘natural’ restriction, regardless of where or how those activities take place. On April 27, 2015, Judge Christina Reiss denied the food industry’s efforts to suspend enforcement of the Vermont law. While this law is currently being appealed, there is yet no hint that it will be delayed from going into effect next summer.
Safe and Accurate Food Labeling Act of 2015. This federal Act would establish national standards for voluntary claims that a food is or is not derived from GE, direct FDA to define the term “natural”, and preempt any existing (Vermont’s Act 120), and future state and local GE labeling requirements. This bill passed the House but has yet to be introduced into the Senate.
FDA’s Denial of Petition for Mandatory GE Labeling. In November, 2015, FDA denied a petition from the Center for Food Safety asking FDA to require mandatory labeling of GE foods. According to FDA, the petition did not provide sufficient evidence that, as a class, foods derived from GE differ from foods derived from non-GE in any meaningful or uniform way, or present any different or greater safety concerns.
NPA Position on GE and GMO Labeling
On March 18, 2013, the NPA Board of Directors approved the position for our Association on the labeling of foods manufactured from bioengineering or genetically modified organisms (GMOs), which is called the NPA GMO White Paper. In the document NPA outlines the following guiding principles in its call for a national standard on GMO labeling:
- NPA believes consumers have the right to be informed whether genetically modified components are in their foods.
- NPA supports and encourages the voluntary labeling on non-GMO foods.
- NPA believes that consideration of federal law promoting a uniform standard is warranted to avoid separate standards for GMO labeling at the state level.
- NPA opposes a private enforcement provision, which encourages abusive litigation, to impose compliance.
- NPA supports the FDA consistently reviewing the concept of bio-equivalency of genetically modified ingredients in light of the most recent scientific studies.
Our national call for voluntary GMO labeling in our white paper was commended by the national “Just Label It” coalition in the hopes of supporting a national solution for mandatory labeling of genetically engineered (GE) food. Consumers have a right to know what is in their food, and a national standard is the best, most cost-effective and least-confusing way to deliver on this commitment to ensure the continued growth and sustainability of the natural products industry.
NPA Supports a National Natural labeling Standard for terms like non-GMO, non-GE, and Natural.
NPA prefers one overarching labeling standard over terms involving “GE”, “GMO” and “natural” as opposed to multiple iterations from the states. In the current announcement, the FDA is clear in providing guidance for those manufacturers who choose to voluntarily label their products. A guidance document is not regulation, and therefore not legally binding for the industry to label, but the guidance does provide some clarification to the natural products industry.
Mandatory labels would require a new implementing regulation and mandatory labeling on GE and non-GE foods could imply a warning about health effects to the consumer.
A prominent and mandatory label has been shown from scientific studies to stigmatize, scare and mislead consumers who view the statement as a warning. This could hurt foods who voluntarily label their individual ingredients as “GE” or “non-GE”. Therefore, innovative products with non-biologically engineered ingredients could be kept from market.
NPA believes FDA and FTC already have the regulatory tools available to them to enforce the laws over false and misleading statements on labeling and deceptive statements in advertising.
There are FDA labeling laws already in place for changes that are “material” (i.e. to nutrition). FDA states that genetic bioengineering does not change the food in any meaningful way in that there are no different or greater safety concerns. If there are safety concerns over the food, these concerns would require a label under existing laws.
Mandatory labels would also lead to overwarning and desensitization by the consumer in seeing these labels everywhere as is the case with Prop 65 warnings in California.
“Overwarning” by Prop 65 in California is defined as a symptom resulting from the overexposure by consumers to the same label on products leading to their desensitization and apathy toward the stated message. The natural products industry does not want to head down the same path as Prop 65, which has stymied economic growth there by detracting new businesses away from the state of California.
FDA Failed to Provide an Economic Analysis of the Burden to Industry Over Voluntary LabelingNPA supports establishment of FDA regulations for genetically engineered foods.
The NPA urges the FDA to take action to develop consistent and equitable GE labeling requirements.