Tag Archives: Food and Drug Administration

Monster Changes From Nutritional Supplement to Traditional Drink

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.

Nutrition Facts – 20 Years and “Evolving”

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.

 

ConAgra Sued for False Advertising Over Parkay Spray butter substitute

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.

FDA Rejects Corn Refiner’s Petition to Allow “Corn Sugar” as Alternate Name for HFCS

In November 2010, the Corn Refiners Association (“CRA”) petitioned the FDA to allow “corn sugar” as an alternate ingredient name for high fructose corn syrup (“HFCS”).   The corn industry wanted to escape an increasingly negative impression of HFCS by using a more wholesome and “less complicated” name for the ingredient.  This petition was strongly opposed — not surprisingly — by the sugar industry, which went so far as to sue the CRA in federal court for ads which stated, “Whether its corn sugar or cane sugar, your body can’t tell the difference.”

On May 30, 2012, the FDA issued its Response which squarely rejected the CRA’s petition.  First, the ”FDA’s regulatory approach for the nomenclature of sugar and syrups is that sugar is a solid, dried, and crystallized food; whereas syrup is an aqueous solution or liquid food….  FDA’s approach is consistent with the common understanding of sugar and syrup as referenced in a dictionary.”  Accordingly, ”use of the term ‘sugar’ to describe HFCS, a product that is a syrup, would not accurately identify or describe the basic nature of the food or its characterizing properties.”

Second, “FDA’s longstanding regulations … describe and define corn sugar as ‘dextrose’” and the petition does not support using “corn sugar” as “an alternative name for a sweetener that is different from dextrose.”

Finally, “corn sugar” has “been known to be an allowed ingredient for individuals with hereditary fructose intolerance” and  ”changing the name for HFCS to “corn sugar” could put these individuals at risk and pose a public health concern.”

Accordingly, the CRA’s petition didn’t “provide sufficient grounds for the agency to authorize ‘corn sugar’ as an alternate common or usual name for HFCS.”

The FDA’s ruling will certainly be fodder for the sugar association’s efforts to combat the CFR’s marketing campaign.  On the other hand, the CFR has already stated that the FDA’s denial was based “on narrow, technical grounds” and “[t]hey did not address or question the overwhelming scientific evidence that high fructose corn syrup is a form of sugar and is nutritionally the same as other sugars.”  Sounds like this bitter, PR battle will continue for some time.  At this time, however, the Sugar industry has the upper hand.

Part 2 of My Front-of-Package Labeling Overview for About.com

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.

Quoted Today in the Chicago Daily Law Bulletin Regarding “All Natural” Claims.

I was happy to be quoted in today’s edition of the Chicago Daily Law Bulletin for an article titled “Food Makers Face Litigation Due To ‘Natural’ Claims.”   Among the quotes, I mention:

  • “Once you aren’t dealing with a from-the-earth product, it is difficult to draw the line between natural and ‘non-natural’ when describing food products on store shelves.”
  • “The main issue for the court is determining if that is misleading for a reasonable consumer,” Ter Molen said, adding that courts “are reluctant to get involved in this determination because they think this is either an inquiry that’s right up the FDA’s alley or a political question that should be resolved by the legislature.” 

 Here’s a link to the article (and yes, reprint rights were obtained from the Chicago Daily Law Bulletin).