August 14, 2001

By Fax and Overnight Mail
Bernard A. Schwetz, DVM, PhD.
Acting Principal Deputy Commissioner
U.S. Food and Drug Administration
Department of Health and Human Services
5600 Fishers Ln. Room 14-71
Rockville, MD 20857

Re: Misbranding Of Foods That Manufacturers Claim Do Not Contain Genetically Engineered Ingredients.

Dear Acting Principal Deputy Commissioner Schwetz:

The Center for Science in the Public Interest (CSPI)⁽¹⁾ is filing this complaint to request remedial action concerning seven products whose labels are misbranded in violation of §§201(n), 301, and 403(a) of the Federal Food Drug and Cosmetic Act (FFDCA), 21 U.S.C. §§321(n), 331, and 343(a). Each product label makes false or misleading claims regarding the absence of genetically engineered (GE) ingredients and violates FDA’s recent draft Guidance to Industry on "Voluntary Labeling Indicating Whether Foods Have or Have Not Been Developed Using Bioengineering" (hereinafter referred to as "Labeling Guidance"). CSPI supports appropriate labeling of foods to identify whether they contain or do not contain GE ingredients, but, in light of our recent survey on this subject, sees the need for further guidance and regulatory action to ensure that labels on this subject do not deceive or mislead consumers.⁽²⁾ Thus, CSPI requests that FDA take enforcement actions to stop these companies from marketing the misbranded products identified below.

I. Background

In the past five years, the media in the U.S. and abroad have publicized the controversy over GE food crops. Those crops, particularly corn, soybeans, and cotton in the U.S., have gained favor among farmers because they allow for reduced use of dangerous pesticides, permit farming methods that reduce the need for soil tillage, and save money. The use of GE crops has resulted not only in reduced exposure of farmers to pesticides, but also in benefits to the environment, such as reduced harm to insects, reduced soil erosion, and better water quality.

Some people have criticized GE crops for their lack of regulation, potential harm to the environment, and control by a small number of companies. Some critics have also proclaimed or suggested that GE crops are less safe than conventionally grown crops to the consumer. Because of the wide publicity given to such claims, some consumers have been persuaded that foods made from GE crops are less good or less safe than foods made from conventionally grown crops. See CSPI Survey Results (Attachment B). Some companies, looking for a marketing advantage, have begun capitalizing on some consumers’ conclusions about GE crops by presenting the absence of GE ingredients as a sign of superiority. Consumers who are swayed by such claims may be induced to switch brands or pay higher prices even though currently there is no real difference between ingredients made from GE and non-GE crops.

Many consumers say they would like information on the labels of the food they buy that specifies whether any ingredients came, or did not come, from GE crops. For instance, CSPI’s recent national telephone survey found that about two-thirds of consumers (62-70%) want GE foods to be labeled. Other surveys have found similar support for labeling. Such information, however, must be provided in a way that is accurate as well as non-disparaging of products made with GE ingredients.

When consumers go to the supermarket today, they increasingly find products, such as the ones noted below, claiming not to contain GE ingredients (hereinafter referred to as "absence" labeling). Many of those absence claims, however, are false or misleading in one or more respects, violating the misbranding provisions of the FFDCA and FDA’s Labeling Guidance.⁽³⁾ For example, some labels use specific terms such as "organism" or "genetic modification" in a false or misleading manner. Other "absence" label statements imply or are perceived to indicate that the products are superior to comparable products, when that is not the case.⁽⁴⁾ The misbranded products described below are representative of a growing practice in the food industry.

The manufacturers of the products discussed below have chosen, whether intentionally or unintentionally, specific language and graphics that convey false or misleading information that takes advantage of consumers’ fears and lack of knowledge about genetic engineering. The FDA has indicated its opposition to deceptive claims about genetically engineered ingredients through its publication of the Labeling Guidance. To eliminate these current deceptions and to ensure more honest labels in the future, we now are asking the FDA to back up its expressed concerns by halting the deceptive claims on products now in the marketplace.⁽⁵⁾

II. The Products⁽⁶⁾ Are Misbranded Because of False or Misleading Label Statements About the Absence of GE Ingredients

A. Misleading Use of Term "Organism"

An "organism" is generally defined as a whole living plant, animal or bacteria. Most foods do not contain "organisms" (yogurt is an exception). Stating that a particular food is "organism free" (or "GMO-free")⁽⁷⁾ is misleading because it implies that other comparable foods do contain organisms when that is not the case (at least in the instant examples). It is safe to assume that consumers generally do not want their food to contain organisms because they interpret "organism" to mean either that a product contains something alive or that it may be contaminated.

An "organism free" or "GMO-free" claim could mislead many people into believing that the food without "organisms" has actually been specially formulated or processed to eliminate organisms (when that is not the case), thereby making the product safer or superior to other comparable products. For example:

• Polaner’s All Fruit Strawberry⁽⁸⁾ states that it is "NOW GMO FREE" on the front and that "Every ingredient ... is ... free of genetically engineered organisms" on the back. This jam-like product made primarily with strawberries and fruit juices does not, and never did, contain organisms (unless a strawberry and bacterial contamination are considered organisms). (A copy of this label is provided in Attachment C.)
   
• Earth’s Best Apples and Apricots⁽⁹⁾ baby food states on the rim of the can "NO GMO’s" six times and has a signpost on the front of the label stating "No GMO." No jarred baby food product made with fruits contains any organisms. (A copy of this label is provided in Attachment D.)

• Healthy Times Oatmeal with Banana Cereal for Baby states on the front and back of the package that it is "NON GMO." The major ingredients of this product, oats and bananas are not organisms. Competing products also do not contain organisms. (A copy of this label is provided in Attachment E).

• Van’s Organic Waffles states in two places on the package that it contains "Non-GMO Canola Oil." No canola oil in any packaged food contains organisms. (A copy of this label is provided in Attachment F.)

Each of those types of food does not normally contain "organisms," and it is misleading to the consumer to use terms such as "Non GMO" or "GMO Free" to describe the absence of genetically engineered ingredients. As stated in FDA’s Labeling Guidance, "It would likely be misleading to suggest that a food that ordinarily would not contain entire ’organisms’ is ’organism free.’" (Labeling Guidance at p. 12). Each manufacturer could have chosen to use a nonmisleading word such as "ingredient" instead of "organism," but either intentionally or unintentionally chose a word that misleads the consumer. Therefore, FDA should take action to prevent the misbranding on these products and any other products that bear similar label language now and in the future.

B. Misleading Superiority Claims

FDA, as well as many other authorities,⁽¹⁰⁾ have stated that the currently marketed GE crops are both as safe as and nutritionally equivalent to similar conventionally bred crops. According to FDA’s Labeling Guidance, FDA "has concluded that the use or absence of bioengineering in the production of a food or ingredient does not, in and of itself, mean that there is a material difference in the food." (Guidance at p. 13). Thus, it is misleading if a label implies that a non-GE food is superior to comparable products that contain GE ingredients.⁽¹¹⁾

To determine if a product is making a superiority claim, one needs to look at all information on the whole package, including not just the language but also how it is displayed (size, location, type, color, and so forth) and whether any explanatory language accompanies the claims.⁽¹²⁾ When one examines the complete label for the products discussed in this letter, each package implies that the product is superior:

• Spectrum Canola Oil. The front of the jar has an "attention getting" red circle containing the letters GMO that are struck through with a red line. That graphic strongly implies that GE canola is bad and that this product is superior because it does not contain any of that canola. In fact, GE canola oil is identical to conventionally grown canola oil. (A copy of this label is provided in Attachment H).
   
• Erewhon Wheat Flakes. This package has a large circle on the front which states "NO" in 1/2"-high upper-case red letters and "GENETICALLY MODIFIED INGREDIENTS" in 3/16"-high upper-case red letters. Those words are surrounded by a multi-pointed sunburst and the words "100% NATURAL." The shopper’s eyes are immediately drawn to this large circle and the emphasis on the word "NO", which implies that the absence of GE ingredients makes the product healthier. Thus, the labeling implies that this product is superior because it does not contain genetically engineered ingredients. In fact, no GE wheat is present in any food and, even if it were, such wheat likely would be essentially identical to conventional wheat. (A copy of this label is provided in Attachment H)
   
• Healthy Times Oatmeal with Banana Cereal for Baby. This product states once on the front and four times on the back of the package that it is "NON GMO" or "made without genetic modification." In each instance, the claim is set out to catch the shopper’s attention by using a box, different color lettering, or by underlying the word "without" with a curved red line. The overall impression of those statements and devices conveys to the consumer that this product is superior because it does not contain GE ingredients. In fact, no GE oatmeal or bananas are even marketed, and, even if they were, such oatmeal and bananas likely would be essentially identical to conventional oatmeal and bananas. (Attachment E).
   
• Earth’s Best Apples and Apricots. This product states six times on the rim of the jar that it has "NO GMO’s." In addition, the front-label statement "NO GMO" and the back-label statement "No Genetically Modified Ingredients" are written in large red type; other claims in non-red type state that the product is "certified organic," has "no preservatives," and so forth. Taken together, those statements imply to the consumer that this product is superior, in part, because it does not contain GE ingredients. In fact, no GE apples or apricots are even marketed, and, even if they were, such apples and apricots likely would be essentially identical to conventional apples and apricots. (Attachment D).
   
• Polaner All Fruit Strawberry.⁽¹³⁾ This product states on the front label in large red, upper-case letters in a bright yellow box that it is "NOW GMO FREE." The placement and portrayal of that claim appear intended to imply that this product is superior to other similar products because it does not contain GE ingredients. In fact, strawberry jams and jellies made with GE ingredients (i.e. corn syrup from GE corn) are essentially identical to this product and certainly no less safe. (Attachment C)
   
• Bearitos All Natural Tortilla Chips. This product states in a red circle in the middle of the front of the package that it is a "Pure Food"and contains "NO Genetically Engineered Ingredients." The placement of the no-GE claim and the use and emphasis of the words "Pure Food" appear intended to imply that this product is superior to other similar products and that the use of GE ingredients would render a food impure. In fact, GE tortilla chips are essentially identical to this product, though we acknowledge there are environmental benefits of organic agriculture. (A copy of this label is provided in Attachment I.)
   
• Van’s Organic Waffles. This product states that it contains "Non-GMO Canola Oil" in several prominent locations on the package. That statement appears intended to imply that this product is superior to other similar products that use GE canola (or other GE) oil. In fact, this product is no better; GE canola oil is identical to conventional canola oil. (Attachment F).

For all of those products, the overall impression conveyed by the label implies that the product is superior by virtue of the absence of GE ingredients.⁽¹⁴⁾ Thus, enforcement action by FDA is necessary to eliminate this deception.⁽¹⁵⁾

C. Misleading Absence Claims for Products With No Marketed Bioengineered Varieties of Any of its Ingredients

A label statement can be misleading if it implies, incorrectly, that other foods in the category contain an ingredient that this product affirmatively does not contain. For example, it would be misleading to call attention on a label to the fact that your brand of plain white rice is "salt free," when in fact, all brands of rice are salt free. Similarly, "absence" label claims that specifically state that a product does not contain GE ingredients could be misleading if there is no GE counterpart on the market for any of the product’s ingredients. As stated in FDA’s Labeling Guidance, "a statement may be misleading if it suggests that a food or ingredient itself is not bioengineered, when there are no marketed bioengineered varieties of that category of foods or ingredients." (Guidance at p. 14). For example, the labels on

• Erewhon Wheat Flakes states that the product is "100% Natural NO GENETICALLY MODIFIED INGREDIENTS." The major ingredients of this product are wheat kernels, sea salt, and barley malt, none of which have any marketed bioengineered counterparts. (Attachment H).
   
• Healthy Times Oatmeal with Banana Cereal for Baby states that it is "NON GMO" and "made without genetically modified ingredients." This product is made primarily with oats and bananas, neither of which has any marketed bioengineered counterparts. (Attachment E).
   
• Earth’s Best Apples and Apricots baby food states on the rim of the jar "NO GMO’s" and on the label that it has "No Genetically Modified Ingredients." This product is made primarily with apples and apricots, neither of which has any marketed bioengineered counterparts. (Attachment D).
   
• Polaner All Fruit Strawberry states "Contains No Genetically Modified Organisms." This product is made primarily with pear and grape juice concentrates, strawberries and fruit pectin, none of which have any marketed bioengineered counterparts. (Attachment C).
   
• In each of those examples, those products could not be made with GE ingredients because there is no GE wheat, apples, apricots, strawberries, bananas, or oats in commercial use. Therefore, without any explanation of the label stating that all similar products also do not contain GE ingredients, it is misleading (though technically accurate) to label those products as not containing GE ingredients and FDA should take action to prevent those misbrandings.

D. False or Misleading Use of Term "Genetically Modified"

Labels that state that a food or its ingredients have not been "genetically modified" technically are both false and misleading. "’Genetic modification’ means the alteration of the genotype of a plant using any technique, new or traditional" and "’modification’... means the alteration in the composition of food that results from adding, deleting, or changing hereditary traits, irrespective of the method." (Labeling Guidance at p. 11). Virtually all cultivated food crops — corn, oats, bananas, strawberries, canola, wheat, and apples, for example — have been genetically modified. Therefore, as stated in FDA’s Labeling Guidance, "it likely would be inaccurate to state that a food that had not been produced using biotechnology was ’not genetically modified’ without clearly providing a context so that the consumer can understand that the statement applies to bioengineering." (Guidance at pp. 11-12).

For each product identified below, the label is false and misleading because each product contains ingredients that have been genetically modified.

• Erewhon Wheat Flakes states on the package "100% Natural NO GENETICALLY MODIFIED INGREDIENTS"; yet two of its ingredients, wheat and barley, have been modified by traditional breeding. (Attachment H).
   
• Polaner All Fruit Strawberry states on the package "Contains No Genetically Modified Organisms"; yet strawberries, a major ingredient, have been modified using traditional breeding methods. (Attachment C).
   
• Healthy Times Oatmeal with Banana Cereal for Baby states that it is "NON GMO," "made without genetically modified ingredients, and "Grown and processed without genetic modification"; yet oats and bananas have been modified using traditional breeding. (Attachment E).
   
• Earth’s Best Apples and Apricots baby food states on the rim of the jar "NO GMO’s" and on the label that it has "No Genetically Modified Ingredients"; yet apples and apricots have been genetically modified over the years. (Attachment D).
   
• Van’s Organic Waffles states that it uses "NON GMO Canola Oil" even though canola is a crop that has been genetically modified over the years. (Attachment F).
   
• Spectrum Canola Oil states that it uses "NON-GMO SEED STOCK"; yet canola seeds have been modified by traditional methods. (Attachment G).

In each of those products, key ingredients have been modified through conventional breeding methods yet the product claims this is not the case. Thus, FDA should prohibit those false and misleading label statements and any other claims that are similar in nature.⁽¹⁶⁾

E. Misleading Statement About One Ingredient

It can be misleading to consumers to point out an attribute of one ingredient when other ingredients in that same product do not have that same attribute. For example, it would be misleading to label a frozen meatloaf and mashed potatoes dinner as having "salt free" mashed potatoes when the meatloaf has hundreds of milligrams of salt. Similarly, it is misleading to state that one ingredient of a food does not come from GE crops without disclosing that other ingredients in that same food may come from GE crops. As stated by FDA in its Labeling Guidance, "a statement that an ingredient was not bioengineered could be misleading if there is another ingredient in the food that was bioengineered. The claim must not misrepresent the absence of bioengineered material." (Guidance at p. 13).

Van’s Organic Waffles states on its label that it contains "Non-GMO Canola Oil." However, those waffles also contain soy lecithin and corn starch. Genetically engineered varieties of both corn and soybeans may have been used to produce those ingredients. Therefore, the label would be misleading if those ingredients did, indeed, derive from GE crops (even though, of course, the soy lecithin and the corn starch would be identical, whether they were purified out of GE or non-GE crops).

III. Legal Authority For FDA Enforcement Action

FDA has the legal authority to take the actions requested in this letter under sections 201(n), 301(a), 301(b), 403(a) and 701(a) of the FFDCA. Section 301(a) prohibits the introduction into interstate commerce of any food that is "misbranded" while Section 301(b) prohibits "misbranding" of any food already in interstate commerce. Each product identified in this letter is currently in interstate commerce.

Section 403(a) states that a food shall be deemed "misbranded" if "its labeling is false or misleading in any particular." Any single false, misleading, exaggerated, ambiguous or over-emphasized statement or representation in labeling misbrands a food. U.S. v. Vitasafe Formula M, 226 F. Supp. 266 (D.C. N.J.).⁽¹⁷⁾ In addition, the label statement can be misleading without being false. Van Liew v. U.S. 321 F.2d 664 (5th Cir. 1963).

Section 201(n) of the FFDCA states that a food may be considered misbranded by virtue not just of explicit representations but also by "the extent to which the labeling or advertising fails to reveal facts material in the light of such representations." Thus, a claim may be misleading unless it is accompanied by certain material facts that are necessary for consumers to understand the nature of the claim.

When reviewing label statements, words used on the label, such as "organism" and "modification," are given their ordinary and popular meaning. Libby, McNeill & Libby v. U.S., 210 F 148 (4th Cir. 1913). In addition, the test for whether a label is misleading is not necessarily the effect on a "reasonable consumer" but upon "the ignorant, the unthinking and the credulous." United States v. An Article . . . Sudden Change, 409 F.2d 734, 740 (2d Cir. 1969).

For each of the products identified in this letter, the label statements about the absence of GE ingredients violate Sections 403(a) and/or 201(n) because they are false or misleading to the consumer. In addition to violating FFDCA, the label statements also violate the FDA’s draft Labeling Guidance on GE and non-GE foods. FDA’s draft Labeling Guidance makes it is clear that the agency will consider false or misleading words such as "organism" and "genetic modification" along with any implied or direct superiority claims. Therefore, taken together, FFDCA and the Labeling Guidance provide sufficient basis for determining that the false or misleading labels discussed above qualify as misbranded foods requiring enforcement by FDA.

IV. Conclusion

Many consumers say they would like information about whether their foods contain GE ingredients but that information must be accurate, value-free, and non-disparaging. This letter identifies seven products that are misbranded under the FFDCA and the FDA’s Labeling Guidance because the products’ labels bear false or misleading information about the absence of GE ingredients. FDA should take prompt enforcement action against those products to ensure that consumers are not deceived or taken advantage of by those food manufacturers. Enforcement by FDA will make it clear to the food industry that the agency takes seriously its responsibility to prevent deception in the food marketplace.

Although this letter only identifies seven products, those products are representative of many additional products that have or will make similar claims. Thus, FDA should establish regulations setting forth more specifically than the draft Labeling Guidance how labels should describe the absence of GE ingredients.⁽¹⁸⁾

If you have any questions about this letter, please call me (202-332-9110, ext. 369). We would be pleased to meet with you to discuss this matter further.

Gregory Jaffe
Co-Director, Biotechnology Project

1. CSPI is a nonprofit education and advocacy organization that focuses on improving the safety and nutritional quality of our food supply and on reducing the damage caused by alcoholic beverages. CSPI seeks to promote health through educating the public about nutrition and alcohol; it represents citizens’ interests before legislative, regulatory, and judicial bodies; and it works to ensure advances in science are used for the public good. CSPI is supported by the 900,000 member-subscribers to its Nutrition Action Healthletter and by foundation grants. CSPI receives no funding from industry or the federal government.

2. CSPI recently sent FDA comments on its Labeling Guidance which supported mandatory identification of GE ingredients on food labels as long as the label statements are accurate, value-free, non-disparaging, and do not significantly increase the cost of the products to the consumer. A copy of those comments is attached as Attachment A. This letter should be considered by FDA as further comments on that guidance. CSPI also recently conducted a national opinion poll which asked consumers about their perceptions about labels identifying the inclusion or absence of GE-ingredients. A copy of the report summarizing the survey’s finding is attached as Attachment B.

3. Although FDA’s Labeling Guidance is currently only a "draft," it is FDA’s current interpretation on what types of "absence" labeling would violate FFDCA. Thus, irrespective of its current status as a draft, FDA must enforce any violations of the Labeling Guidance because they constitute violations of FFDCA.

4. Claims that misleadingly imply superiority are particularly troublesome because manufacturers can take advantage of consumers by charging a premium for products that are not more nutritious or safer that competing products.

5. Although enforcement actions will address the seven products described in this letter, this problem will likely continue until FDA establishes regulations (as opposed to mere "guidance") setting forth specifically how labels should describe the presence and absence of GE ingredients. CSPI reiterates its previous comments to FDA on March 16, 2001, that FDA consider mandatory labeling of all products for the presence of GE ingredients. Specific regulations on this subject are the best way to eliminate misleading and deceptive label claims.

6. Some of the label statements identified in this letter pre-date FDA’s draft Labeling Guidance. Thus, some companies could be modifying their labels to conform with the Labeling Guidance. Until any new label statements are in commerce, however, these products will continue to mislead consumers.

7. "GMO" is commonly understood to mean "genetically modified organism."

8. Although this letter refers to Polaner All Fruit Strawberry, a fruit preserve, the same label statements can be found on all Polaner All Fruit varieties. Thus, any enforcement action taken by FDA should not be limited to the Polaner strawberry product.

9. Although this letter refers to Earth’s Best Apples and Apricot, the same label statements can be found on many other jars of Earth’s Best baby food. Thus, any enforcement action taken by FDA should not be limited to the apples and apricot product.

10. These authorities include the American Medical Association, the National Academy of Sciences, and the Royal Society in the United Kingdom.

11. In addition, these superiority claims ignore the fact that GE crops actually may be better than conventional crops. Some GE crops are grown with less insecticides and therefore are safer to non-target organisms and farm workers and may result in less residues on the food itself; other GE crops grown with safer herbicides may result in less soil erosion and water pollution.

12. FDA’s Labeling Guidance specifically says that "the agency will evaluate the entire label and labeling in determining whether a label statement is in a context that implies that the food is superior." (Guidance at p. 13).

13. CSPI has complained to the FDA about the deceptive name of Polaner "All Fruit" products. Typically the major ingredients in the product are not the named ingredients, but cheap pear and grape juice. Petition for Proposed Rulemaking and Regulatory Action to Prohibit Misleading Food Labeling, Docket No. 95P0256 (August 2, 1995).

14. CSPI’s recent national opinion poll indicated that many consumers, if they had a choice, would buy non-GE foods, because label statements imply to them that non-GE foods are better and safer than comparable GE foods. Given the fact that almost a third of consumers believe that non-GE foods may be superior, it is important that any label statements about this issue be as accurate and non-disparaging as possible. See Attachment B for a more detailed discussion of the results of CSPI’s survey.

15. "Absence" claims can be provided in ways that would not result in expressed or implied superiority claims, although some of these options would require additional consumer research and then guidance or rulemaking by FDA. For example, a label claim on a product made without GE corn would be less misleading than the statements made on the products described in this letter if it were expressed as a statement in its ingredient list: "corn (not genetically engineered)." Alternatively, a simple statement such as "This product was not made with genetically engineered ingredients" placed below the Nutrition Facts box in the same type face and size as used for the ingredient list also would be less misleading. Also, a bold, truthful front-label claim that a food is "made without genetically engineered ingredients" might need accompanying explanatory language (such as, "not superior to conventional ingredients") to minimize deception or shoppers’ erroneous perceptions.

16. As with use of the term "organism," the manufacturers of those products could use factually accurate terms such as "genetic engineering" or "biotechnology" on their labels to solve this misbranding.

17. This case was remanded on other grounds, 345 F. 2d 864, cert. denied 382 U.S. 918. See also V.E. Irons, Inc. v. U.S., 244 F.2d 34, 42 (C.A. Mass. 1957) cert. denied, 354 U.S. 923 (1958) (the intent of the act is to prevent deception whether by "palpably false claims" or by "clever indirection and ambiguity in the creation of misleading impressions.")

18. Eventually, product labels will tout the alleged benefits to consumers or the environment of GE ingredients. In anticipation of that, the FDA also should develop regulations that are more specific than the draft Labeling Guidance to ensure that such claims are accurate, value-free, and non-disparaging.