Michael F. Jacobson, Ph.D.
Executive Director
Center for Science in the Public Interest
1875 Connecticut Ave. N.W.
Washington, D.C. 20009
(202) 332-9110

January 29, 2001

Office of the Secretary
Federal Trade Commission
Pennsylvania Avenue and 6th Street, N.W.
Washington, D.C. 20580
 

     Pursuant to Section 4(d) of the Administrative Procedure Act, 5 U.S.C. § 553(e), and 16 C.F.R. § 2.1, the Center for Science in the Public Interest (CSPI)⁽¹⁾ requests that the Federal Trade Commission halt misleading health claims made in print advertising by the Almond Board of California. These advertisements constitute "false advertisements" as defined by Sections 12 and 15 of the Federal Trade Commission Act (FTCA), 15 U.S.C. §§ 52, 55, and hence are "unfair or deceptive" under Section 5 of the FTCA, 15 U.S.C.§ 45, as interpreted by the Commission in its "Enforcement Policy Statement for Food Advertising."

     To the extent that the U.S. Department of Agriculture (USDA) has concurrent jurisdiction over the matter,⁽²⁾ we request that the Commission work with USDA officials to remedy the concerns raised in this petition.

I. FACTUAL BACKGROUND

     The Almond Board of California has run a national advertising campaign, called the "Almond Cholesterol Challenge." One print advertisement for the campaign features a consumer testimonial in which a woman states that, "I took the almond challenge and dropped my cholesterol 58 points."The print ad continues by noting that heart disease is "the #1 health risk among women today" and that high cholesterol can increase your risk. The ad says: "Just add 3 ounces of almonds a day to your diet for 30 days and watch for a positive result in your cholesterol level."⁽³⁾

II. THE ALMOND BOARD OF CALIFORNIA’S CLAIM REGARDING THE IMPACT OF ALMOND CONSUMPTION ON THE RISK OF CORONARY HEART DISEASE (CHD) IS DECEPTIVE.

A. The claim is deceptive because it is not "adequately qualified" to convey the extent of scientific support.

     The almond advertisement makes a health claim that links increased almond consumption to decreased blood cholesterol levels and, thereby, a decreased risk of Coronary Heart Disease (CHD). An almond/CHD health claim has not been approved by the Food and Drug Administration (FDA) and therefore cannot appear on the labels of almond products.

     The FTC, however, does not require that a health claim be approved by the FDA in order for it to appear in a food advertisement. In its Enforcement Policy Statement on Food Advertising (EPS)⁽⁴⁾, the Commission indicates that, under limited instances, it may allow a health claim in a food advertisement that has not been approved for a food label if it is "expressly qualified to convey clearly and fully the extent of the scientific support." Such a claim must be presented in a manner that "ensures that consumers understand the extent of the support for the claim." If not, then "in the absence of adequate qualification, the Commission will find such claims deceptive."⁽⁵⁾

     The almond/CHD claim in the Almond Board’s ad fails to satisfy the EPS qualification standard because it does not include, as required by the FTC, any "specific disclosures concerning the extent of supporting scientific evidence" nor is it "expressly qualified to convey clearly and fully the extent of the scientific support."⁽⁶⁾ Since no attempt is made in the ad to explain the level of support for the almond/CHD claim, the ad clearly violates the EPS.

     The Commission has published a staff report on consumer research which, among other things, attempts to determine which types of disclosure statements that qualify the level of support for an advertising claim would be most effective. The report concluded that the "second level" of qualification tested (explicit references to inconsistent study results or ongoing scientific debate, such as "It’s too early to tell for sure" and "Longer term research is needed") can have a significant impact on consumer perceptions of the level of proof underlying a health claim.⁽⁷⁾ The Almond Board ad, however, fails to include such qualifying statements.

B. The claim is deceptive because it fails to disclose that almonds are high in calories, a fact that is relevant to the risk of CHD.⁽⁸⁾

     While the almond ad states that increased almond consumption will lower your blood cholesterol levels, and thereby lower your risk of CHD, it fails to disclose that almonds are high in calories. This information is absolutely essential because, if a person eats the recommended daily amount (three ounces) of almonds, he or she will consume an extra 500 calories each day. Unless the person makes an equivalent reduction in caloric intake, he or she will gain weight, and being overweight increases the risk of CHD.

     Under its health claim rules for labeling, the FDA generally does not allow a health claim on a food label if that food contains more than a set level of certain risk-increasing nutrients (total fat, saturated fat, cholesterol, and sodium).⁽⁹⁾ The FTC, however, does not follow the FDA’s "disqualifying level" approach to health claims; rather, the Commission has indicated that it will "carefully scrutinize health claims for such foods to ensure that the claims are truthful and adequately qualified."⁽¹⁰⁾ As it explains in the EPS, such claims —

are likely to be deceptive when the risk-increasing nutrient is closely related to the subject health claim. Often the presence and significance of such a nutrient will have to be disclosed. Without such disclosures, consumers could infer from the health message that the food does not present any related health risks. The failure to disclose the presence and significance of risk-increasing nutrients that are closely related to the health claim for such foods is likely to constitute an omission of a material fact and render the health claim deceptive.⁽¹¹⁾

     The Commission notes that this approach does not only apply to situations involving risk-increasing nutrients. As it explains in the EPS, "[s]ituations involving risk-increasing levels established by FDA should not be interpreted as an exhaustive list of instances in which a broad, unqualified health claim for a food may be found deceptive by the Commission."⁽¹²⁾

     We believe that the claim made in the Almond ad is just the type of broad, unqualified claim that the Commission had in mind when it noted that the failure to disclose the presence of a risk-increasing nutrient is not the only situation when an omission will be found to be deceptive. Here, it is not a specific nutrient but, rather, the fact that almonds are high in calories that is the omitted, material fact. The ad encourages people to eat three ounces of almonds daily, which would add 500 calories to a person’s daily diet. This increase in caloric intake is significant. A post-menopausal woman, like the one pictured in the ad, is at particular risk for heart disease. Adding 500 calories to the 1,900 calories recommended for the average woman over 50 would constitute a 26 percent increase in her daily caloric intake.⁽¹³⁾

     Without any equivalent reduction in caloric intake, a person who adds three ounces of almonds each day to his or her diet will gain weight. Weight gain is "closely related" to CHD. Being overweight, like having a high blood cholesterol level, is one of the risk factors for heart disease.⁽¹⁴⁾ For this reason, the Almond ad, without any disclosure alerting consumers to the caloric content of almonds, fails to meet the requirements of the EPS and is deceptive under the FTCA.⁽¹⁵⁾

     There are a number of ways that the required information could be disclosed. One possible disclosure is "Three ounces of almonds contain 500 calories and will promote weight gain unless you substitute them for other foods in your diet that provide an equal amount of calories." A second option is "Three ounces of almonds contain 500 calories. The best way to reduce your risk of heart disease and not gain weight is to include almonds as part of a diet that low in fat and calories." Another is "Almonds are high in calories. Increased consumption of almonds, without eliminating an equivalent amount of calories from your diet, would result in weight gain, which raises the risk of disease."⁽¹⁶⁾

III. CONCLUSION

     The ad discussed here has the potential to cause substantial injury to consumers. The Almond Board ad fails to qualify the nature of the scientific evidence upon which the claim is based. The ad also fails to disclose that almonds are high in calories and that increased consumption of almonds could lead to obesity, which in turn may increase the risk of CHD.

     For the foregoing reasons, we request that the Commission:

     (1) Bring an action pursuant to Section 13 of the FTCA, 15 U.S.C.§ 53, to enjoin further distribution of any ad by The Almond Board of California regarding the impact of almond consumption on the risk of Coronary Heart Disease pending issuance of a complaint under Section 5 of the FTCA, 15 U.S.C. § 45;

     (2) Initiate action under Section 5 of the Act, 15 U.S.C. § 45, to permanently prohibit dissemination of the ad;

     (3) Require the payment of a monetary penalty;

     (4) Require corrective advertising; and

     (5) Work with officials from the USDA to ensure that USDA-supervised organizations adhere to the laws prohibiting unfair and deceptive advertising.

Respectfully submitted,

 
Bruce Silverglade
Director of Legal Affairs

 
Bonnie Liebman
Director of Nutrition

 
Sandra B. Eskin, Esq.
Of Counsel

1. CSPI is a non-profit consumer organization supported by approximately 900,000 members. CSPI has worked since 1971 to improve national health policies. We have been especially concerned about the effect of food advertising on consumer health.

2. The Almond Board of California, established in 1950, administers a Federal Marketing Order under the supervision of the USDA. See 7 U.S.C. §608c; 7 C.F.R. Part 981.

3. See Attachment 1 (emphasis added).

4. 59 Fed. Reg. 28388 (1994).

5. Id. at 28394. We do not endorse the FTC’s approach that distinguishes between "qualified" and "unqualified" health claims. It is our view that only those health claims supported by "significant scientific agreement" should be allowed on food labels and in food advertisements. However, under the FTC’s approach, we do believe that the claim made in the Almond ad fails to meet the requirements for adequate qualification.

6. Id.

7. Federal Trade Commission, Bureaus of Economics and Consumer Protection, Generic Copy Test of Food Health Claims in Advertising, E-8 (November 1998)(hereinafter "GCT Report"). Similarly, the U.S. Court of Appeals decision in Pearson v. Shalala, 164 F.3d 650 (D.C. Cir. 1999), rehearing en banc denied, 172 F.3d 72 (1999), found that, in some instances, the labels for dietary supplement products can include claims that are supported by less than the FDA’s requirement of "significant scientific agreement." Such a claim, however, must be accompanied by a disclosure statement characterizing the level of scientific support, such as "the evidence is inconclusive," in order to remedy any misleading impression. While it is unclear whether the holding in the Pearson case applies beyond supplement labeling, both this decision and the GCT Report provide some guidance on what constitutes an adequate qualification regarding the level of scientific support.

8. While we rely on the EPS in determining that the Almond Ad is deceptive, we believe that the Commission would find the ad at issue in this petition to be deceptive under its traditional deception analysis. The FTC will find an advertising claim to be deceptive if it contains a representation, omission, or practice that is likely to mislead consumers acting reasonably under the circumstances, and that the representation or omission is material. See Deception Statement, 103 F.T.C. at 183.

The Almond ad satisfies the Commission’s deception standard: 1) The ad makes an affirmative representation that almonds are responsible for the drop in cholesterol levels and leaves out key information about the impact of other factors on cholesterol levels; 2) The representation that eating almonds will reduce your blood cholesterol level, and that a person need not be concerned with the increased caloric intake, is false and thereby, under Thompson Medical Co., Inc., 104 F.T.C. 784, 818-19 (1984), it is likely to mislead; and 3) claims like the almond/cholesterol claim, which involve health and safety, are given a presumption of materiality because of their importance to consumers. See Kraft, Inc. v. FTC, 970 F.2d 311, 322-23 (7th Cir. 1992), cert. denied 113 S.Ct. 1254 (1993)(citing Thompson Medical, 104 F.T.C. at 816-17 and Deception Statement, 103 F.T.C. at 182-83.

9. 21 C.F.R. §101.14(a)(4). The FDA recently made an exception to this general policy when it approved a health claim for plant sterol/stanol esters and blood cholesterol. The agency allowed a limited exception for this health claim based on the fact that, at the present time, fat-based foods, like margarine-like spreads and salad dressings, are the best vehicles for plant stanol/sterol esters, which are fat-soluble substances. See 65 Fed Reg. 54686 (2000).

10. EPS, supra note 4, at 28394.

11. Id.

12. Id.

13. While some people might compensate for the additional 500 calories by automatically eating 500 fewer calories from other foods, many people would not make this adjustment, especially because three ounces of almonds does not appear to be a large quantity of food.

14. See, e.g., DHHS/USDA Dietary Guidelines for Americans 6 (June 2000);American Heart Association, Risk Factors and Coronary Heart Disease

15. Furthermore, we believe that the Almond ad may be deceptive because it fails to refer to changes in a person’s overall diet and exercise regime that, along with increased almond consumption, may contribute to lower blood cholesterol levels. By failing to mention the additional steps necessary to achieve the desired health benefit, the Almond ad may mislead consumers into believing that they can achieve the claimed effect simply by consuming almonds, when this is not necessarily the case. See EPS, supra note 4, at 28396.

While the print ad is silent on the need to make other lifestyle changes in order to achieve the desired health benefit, the Almond Board decided that they were important enough to include on its "Almond Challenge" website. The website notes that a person taking the "Almond Challenge" should first "[s]tart by adding almonds to your daily diet. From there, focus on exercising regularly, eating well, maintaining a healthy weight and cholesterol levels." "Challenging Heart Disease by Challenging Yourself — Sign up Now," See Attachment 2.

Thus, the FTC should investigate whether, as claimed in the ad, an individual can substantially reduce his or her blood cholesterol level by eating almonds alone, without making other lifestyle changes.

16. This last option is consistent with the findings of the GCT Report, which found that consumers responded best when the disclosure presented nutrient content information in plain English, rather than through metric disclosure. See GCT Report, supra note 7, at E-3.