Monster Beverage Co. is changing its labeling so that its energy drinks will no longer be considered dietary supplements, a move that changes the federal guidelines the drinks must follow. Among other things, the drinks will now list “Nutrition Facts” rather than “Supplement Facts” and will disclose caffeine content. As reported by Food Manufacturing,
The change reflects the intensifying scrutiny energy drinks have come under over the past year, with lawmakers calling on the [FDA] to look into the safety of the caffeine levels and other ingredients used in the drinks. It also highlights the confusion consumers may encounter when it comes to the labeling of energy drinks, with companies having the discretion to categorize them as either dietary supplements or traditional drinks.
The No. 2 energy drink, Red Bull, is already categorized as a traditional beverage.
The distinction between a nutritional supplement and a tradition beverage is significant. Traditional foods and drinks can only use ingredients that are approved food additives or that are generally recognized as safe. That is not the case for nutritional supplements, which often contain little-known ingredients such as taurine used in some Monster drinks.
In 2009, the FDA issued guidance stating that dietary supplements were being marketed in ways that suggested they were traditional drinks, including using terms such as “drink”, “juice” and “beverages.” Presently, the FDA is working on final rules to better distinguish distinguish beverage and dietary supplement.
The FDA has posted an interesting article titled “Nutrition Facts Label: 20 and Evolving.” The key point of the piece is self-congratulations with regard to the “revolutionary” nature of this requirement, which was finalized in a final rule on Jan. 6, 1993. The article notes, however, that the Nutrition Facts panel is showing its age:
The agency is planning to update the Nutrition Facts label based on the latest science-based nutrition recommendations.
Paula Trumbo, Ph.D., acting director of FDA’s nutrition programs staff explains that updates are 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.
The updates are still being formulated. Public input will be sought when they are proposed.
More specifically, expectations are that the FDA will propose rules early this year (followed by a period for public comment) revising serving sizes, daily values, and additional nutrient declarations (possible addition of “refined sugars”). The big question is whether anything will be done with regard to label complexity and/or label design. The Facts Up Front campaign has been successful in generating voluntary industry compliance which is the FDA’s preferred approach. But that campaign likely doesn’t go far enough for many industry watchdogs. No matter what rules are proposed, expect a great deal of controversy and discussion regarding what is, and is not, proposed.
As reported by FoodNavigator-USA , a federal judge has dismissed a proposed class action lawsuit against Johnson & Johnson and McNeil Nutritionals over the labeling and marketing of the “cholesterol-busting” spread Bencol. The lawsuit was filed last June and alleged that Benecol misled consumers because, at 0.85 g per serving, it contained insufficient plant stanol esters to merit the relevant health claims. It was also alleged that the claim “proven to reduce cholesterol” rendered the product a drug and not a food.
Generally, the court found that plaintiffs claims were preempted because the FDA issued a statement in 2003 allowing use of the claim in connection with products containing lesser amounts of phytosterols (at least 400mg per serving), and that “Federal agency action short of formal notice and comment rulemaking can preempt state law.” Please see the full article here.
A woman has filed a complaint against ConAgra Foods in U.S. District Court for the District of Nebraska and, as always, is seeking class action certification. Plaintiff alleges that, although ConAgra’s Parkay Spray butter substitute is advertised as “fat free” and “calorie free,” it “contains 832 calories and 93 grams of fat per bottle.” According to the Parkay website, the “Servings Per Container” on the bottle’s Nutrition Facts panel is “about 226 sprays” with a serving size being 5 sprays. Plaintiff, however, alleges that these “product labels include artificially small ‘serving sizes’ that fail to account for the manner in which these products are customarily consumed.” ConAgra’s advertisements are thus false because, according to the Complaint, the product “contains ingredients that are fats which, even in small quantities, add trivial amounts of fat per serving.”
Notably, plaintiff alleges that ConAgra’s labeling directly violates the FDA’s regulatory scheme by providing a smaller “serving size” than the amount of food “customarily consumed at one eating occasion” based on “consumption data under actual conditions of use” as required under C.F.R. §§101.9(b)(1). Based on that contention, Plaintiff further alleges that ConAgra “made unlawful ‘fat free’ and ‘calorie free’ nutrient content claims” because a “product that uses unlawful serving sizes cannot claim to be ‘fat free’ or ‘calorie free.’ 21 C.F.R. §101.62(a)(3); 21 C.F.R. §101.60)a)(3).”
Finally, Plaintiff alleges that Con Agra was aware that its Parkay Spray was mislabeled based on consumer complaints and an FDA guidance letter from March 2005 that “reminded” the food industry about the importance of accurately determining proper serving sizes for their products. The Complaint includes eight different claims with the primary claims alleging violations of Nebraska’s Consumer Protection Act and Uniform Deceptive Trade Practices Act. See the entire Complaint here.
This will be an interesting case to watch because Plaintiff cannot prevail if ConAgra shows that it properly complied with FDA regulations on calculating serving size.
On May 31, 2012, the FDA announced that it was seeking public comment on a potential “Experimental Study on Consumer Responses to Nutrition Facts Labels With Various Footnote Formats and Declaration of Amount of Added Sugars.” The “footnote formats” generally relates to exploring “consumer responses to various food label formats for the footnote area of the Nutrition Facts label, including those that exhibit information such as various definitions for percent Daily Value, a succinct statement about daily caloric intake, and general guidelines for high and low nutrient levels.”
Groups supporting the study include the American Heart Association, the Center for Science in the Public Interest (“CSPI”), and the Rudd Center for Food Policy & Obesity at Yale University. Their comments included the following:
- American Heart Association: “While ‘sugars’ is listed, the Nutrition Facts label does not distinguish between naturally occurring sugars such as those found in fruit or milk, which are associated with other important components inherent to foods such as vitamins and minerals, and added sugars, which are not.”
- Rudd Center: “The Rudd Center suggests testing more succinct statements for recommended caloric intake, including statements of calorie ranges and alternative types of statements indicating that calorie requirements change with age, height, and activity level, and statements suggesting consumers check their own caloric needs on a government run website.” Further, “including added sugar and naturally occurring sugar on the Nutrition Facts Panel under total sugar would increase consumer understanding of products’ nutritional attributes and healthfulness. Consumers are used to seeing subcategories under total fat (i.e., saturated fat, trans fat), so this would be in line with current understanding and increase comprehension of the additional information.”
- CSPI: Besides supporting the proposed study, “CSPI urges FDA also to evaluate the effects of labels that show only added sugars and juice sugars. While CSPI … supports the idea of a Nutrition Facts label that lists added sugars (and juice sugars) instead of total sugars and urges FDA to test such labels, at a minimum Nutrition Facts labels should distinguish between added sugars that consumers should limit (caloric sweeteners and juice sugars) and sugars that occur naturally in milk, fruit, or vegetables.” Even if some sugars are chemically identical, “fruits, vegetables, and low-fat dairy foods may help prevent heart disease, stroke, osteoporosis, and other diseases. In contrast, soft drinks, fruit drinks, bakes sweet, candy, and other sources of added sugars … may increase the risk of disease, either by adding sugars to the diet or by displacing more nutritious foods from the diet.” CSPI’s preferred Nutrition Facts label is set forth below.
Groups opposing the study include the American Bakers Association, the Independent Bakers Association, the American Beverage Association, the International Dairy Foods Association, the National Dairy Council, the National Milk Producers Federation, the National Confectioners Association, Ocean Spray Cranberries and the Sugar Association. Reasons provided in opposition to the study included the following:
- Ocean Spray Cranberries, Inc.: “Ocean Spray’s opposition is threefold: (1) we believe that the focus on added sugars, as opposed to total sugars, is misplaced, (2) the focus on added sugar disproportionally impacts cranberry products, which require sweetening to be palatable, and (3) the FDA lacks authority to require the declaration of added sugars as the FDA has no means of testing for enforcement of an added sugar declaration without requiring access to proprietary formulas.”
- National Dairy Council: “[C]urrent food labels provide information about the amount of total sugars on the Nutrition Facts label and the names of added sugars on the Ingredients Panel. Nutrient content claims, such as reduced sugar, sugar free or no added sugar, may also be present. Consumer research to date indicates that consumer judgments about the nutritional attributes and overall healthfulness of foods and beverages can be impacted by information currently on foods labels. A review of the current research indicates potential for consumer confusion and unintended consequences from declaration of added sugars on the Nutrition Facts label.”
- American Beverage Association: “Although ABA supports FDA efforts to research the ways in which consumers use and understand the Nutrition Facts label, ABA continues to believe that the proposed study’s review of an added sugars declaration is wholly unnecessary and lacks practical utility for a variety of reasons. First, FDA itself has repeatedly taken the science-based position that there is no need for a mandatory disclosure of added sugars since the body does not distinguish between added sugars and those naturally occurring in food. FDA has also expressly acknowledged that an added sugars declaration would be ‘unenforceable’ since the agency would be unable to determine, for many products, the accuracy of any such label declarations. …. Moreover, … it is well-established that added sugars are not uniquely linked to the problem of obesity [and a] misplaced focus on added sugars would only detract from the importance of total calories as the crucial piece of information necessary to inform consumers of the relationship between food intake and weight management. Finally, … the proposed study contains a number of methodological and other flaws and may not produce reliable information on added sugars labeling.”
See all the comments here.
To no one’s surprise, the filing of class action lawsuits against food companies continues at a rapid pace in California. The latest suit, filed on April 12th, alleges that certain King Oscar products labeled as “Rich in Natural Omega-3″ and “Excellent Source Omega-3″ are misleading and fail to disclose “risk-inducing” nutrients.
First, the Complaint alleges that “[w]here a particular nutrient does not have an established daily value (DV) under FDA regulations, food producers may not state on their food labels that their food product is a ‘good source’ of the nutrient, or use a comparable phrase, such as ‘excellent source’ or ‘rich in.’ 21 C.F.R. § 101.54.” It then alleges that Bumble Bee violated this regulation “by representing that its products are an ‘excellent source’ of omega 3 or ‘rich in’ omega 3 and by failing to specify whether its omega 3 nutrient content claims are referring to ALA, DHA or EPA omega 3 fatty acids.”
Second, the Complaint alleges that these same products were improperly labeled under 21 C.F.R. § 101.13 because they fail to include a disclosure statement that the products included more than 13.0 g of fat, 4.0 g of saturated fat, 60 milligrams (mg) of cholesterol, and/or 480 mg of sodium per serving. This prong of Plaintiff’s complaint is included, no doubt, as a means of bolstering the contention that plaintiff and “similarly-situated persons” were somehow harmed by Bumble Bee’s labeling practices.
Significantly, the Complaint continues the ominous trend of citing FDA warning letters to bolster its claims. This time, Plaintiff quotes extensively from an FDA Warning Letter to Natural Guidance LLC to help legitimize its claims and asserts that “[o]ther companies that sell similar Omega 3 nutrient content claims have been found to be in violation of the laws concerning such claims.” That warning letter involved some relatively strident claims by a maker of nutritional supplements. Notably, the Bumble Bee products have more in common with the walnuts sold by Diamond Food which also received of an FDA warning letter regarding Omega 3. The Diamond Food warning letter was the target of legitimate criticism because it seemingly condemned the communication to consumers of properly qualified scientific research. This is similar to the criticism that POM Wonderful has leveled against the FTC, i.e., it is improper to ban non-deceptive speech regarding properly supported, qualified health claims.
Putting aside the FDA’s and FTC’s respective views on this topic, I think the Plaintiff here will a difficult time convincing anyone that they were actually mislead by the Bumble Bee labeling at the time of purchase.
Please see the entire Complaint here.
Please check out the final part of my Front-of-Package Labeling Overview for About.com, which focuses on FOP labeling systems. On this subject, I conclude:
As for the FDA, given its limited resources and preference for industry-led (ground-up) efforts, it is unlikely to take any formal action until it has exhaustively reviewed results of the Facts-Up-Front campaign (and, in all likelihood, Wal-Mart’s program) over the next 12-18 months.
The remainder of 2012 will provide tantalizing clues for the future of food labeling. Will Wal-Mart’s “Great for You” seal influence purchasing decisions or motivate food companies to change product formulations? Is the “Facts up Front” campaign sufficiently robust to help consumers make healthier choices? No matter what happens, though, the use of FOP claims will not likely diminish and will continue to be a subject of much discussion and criticism. Stay tuned.
A decision is expected by April 17, 2012 — at the latest — in the closely watched matter of the FTC v. POM Wonderful, Doc. No. 9344.
The FTC’s administrative complaint charges ”the makers of POM Wonderful 100% Pomegranate Juice and POMx supplements with making false and unsubstantiated claims that their products will prevent or treat heart disease, prostate cancer, and erectile dysfunction.” The targeted advertisements include statements such as:
- “SUPER HEALTH POWERS! … 100% PURE POMEGRANATE JUICE. … Backed by $25 million in medical research. Proven to fight for cardiovascular, prostate and erectile health.”
- “NEW RESEARCH OFFERS FURTHER PROOF OF THE HEART-HEALTHY BENEFITS OF POM WONDERFUL JUICE. 30% DECREASE IN ARTERIAL PLAQUE … 17% IMPROVED BLOOD FLOW … PROMOTES HEALTHY BLOOD VESSELS … ”
- Clinical studies prove that POM Juice and POMx prevent, reduce the risk of, and treat heart disease, including by decreasing arterial plaque, lowering blood pressure, and improving blood flow to the heart;
Unlike other companies, however, POM is determined to fight these allegations to the end. Its primary argument is that the FTC has improperly changed its standard for how advertisers substantiate the truth of their claims. Specifically, “(1) the FTC now requires advertisers to obtain prior FDA approval before making certain types of health related claims about food, beverages, and dietary supplements, … and the FTC is requiring prior FDA approval regardless of whether or not the claims are true or supported by competent, reliable scientific evidence; and (2) the FTC is also requiring two ‘well controlled’ clinical studies for non-disease claims, which also represents a dramatic change in the level of substantition required to establish the truth of these types of claims.” According to POM, this new standard is improper because it did not go through the the formal rulemaking process and, more significantly, it “constitutes a ban on both deceptive and non-deceptive speech, the latter of which is protected by the First Amendment.”
In effect, POM is arguing that for an undisputedly healthy product, the FTC is seeking to bar properly supported, qualified health claims that are protected under the First Amendment. For its part, the FTC maintains that the advertisements were still “deceptive.”
This matter has been fully tried before an FTC Administrative Law Judge and all post-trial briefs have been filed. A decision expected by April 17, 2012 at the latest. Needless to say, it is likely that the FTC’s own court will find in favor of the FTC so expect this one to be appealed.
Posted in First Amendment, Front-of-Package Claims, Front-of-Package Litigation, FTC, Health Claims
Tagged deceptive, FDA, First Amendment, ftc, POM Wonderful, Pomegranate, qualified health claims
It was my privilege to participate in a Q&A with Food Manufacturing on Front-of-Package (FOP) labeling issues and related legal risks. The full Q&A is available here.