WHEN IT COMES TO labeling, or more specifically, accuracy in protein labeling given the litigious society we live in, food and ingredient manufacturers have more to worry about than government oversight from the FDA and FTC. “The FDA looks at your labeling; the FTC looks at your advertising. Most of your labeling is also your advertising. So, you can count on both the FDA and the FTC to look at anything you put out there about your product,” said Justin Prochnow, Stockholder, Greenberg Traurig, LLP, in his presentation “Protein Quality and Labeling: Defending Attacks from Regulators, Attorneys and Competitors.”
Any product-related material is subject to oversight, including labels, brochures, website and media. If a website address appears on a label, or if products are sold from a website, then that website is considered labeling. Anything found on the site is viewed as if it was directly on the product.
Disputes between competitors, typically involving comparative claims, may be heard by the Advertising Self-Regulatory Council, an arm of the National Advertising Division (NAD), which also hears disputes from consumers regarding advertising claims. Yet, it’s the State Attorney Generals and District Attorneys that have captured the spotlight by essentially forming “cabals” of offices that have pursued companies, noted Prochnow. “We’re dealing with a case right now with 13 different States’ Attorney Generals who have piled on. They’ll send you a letter stating you’re making these 15 claims for six of your products. They want to see the science and the substantiation for those claims. And, if you don’t have it, then they’re looking to settle out the same as some of these plaintiff lawyers,” Prochnow added. Meanwhile, the plaintiff attorneys are busy forming class action lawsuits on behalf of consumers for false or misleading claims.
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In dealing specifically with protein declarations per 21 CFR 101.9(c)(7), companies should be well versed in the Daily Recommended Value (DRV) of protein at 50g per day; how to express the number of grams per serving on the Nutrition Facts panel; and whether the daily value percentage (DV%) must be included. The DV% for protein must be included in the Nutrition Facts or Supplement Facts Panel when a protein claim is made, even if that claim is on the front of the package. By not following these rules, companies leave themselves open to lawsuits, which costs both time and money.
Any protein content per serving greater than 1g should be rounded to the nearest whole number. “While the FDA isn’t going to put yellow tape on a product that has 2.7g protein on their label, what it tells the FDA is that whoever’s responsible for labeling didn’t know what they were doing,” said Prochnow. A violation such as this gives the FDA pause, possibly opening the door to further scrutiny in other areas of the business, such as manufacturing.
In the U.S., protein quality—considered a critical attribute—is based on the Protein Digestibility-Corrected Amino Acid score (PDCAAs), which evaluates the quality of a protein based on both the amino acid requirements of humans and their ability to digest it. A protein score of 1 means that the source of protein provides 100% of the amino acid requirements. As various sources of proteins have different PDCAAs, companies need to be cautious when assessing the DV% of protein in its products. Both cows’ milk and soy protein have a PDCAAs of 1, but protein from peanuts have half as much at 0.52 PDCAAs. Therefore, a product containing 10g of whey protein has a DV% of 20%, which al-lows for a “high” or “excellent” source of protein claim, while a product with 10g of peanut protein has a DV% of 10%, and thus supports a “good” source of protein claim.
Three types of claims are permitted for foods, beverages and supplements—nutrient content, structure-function and health claims. Nutrient content claims are the hardest cases to defend (i.e., you either have the amount of nutrient advertised or don’t), noted Prochnow. The types of nutrient content claims permitted are well- defined per 21 CFR 101.54. For instance, descriptions such as “rich in,” “high” or “excellent source of” mean there is a least 20% of the RDI or DRV of the nutrient per Recommended Amount Customarily Consumed (RACC). And, these descriptions are only allowed for ingredients that have an RDI or DRV. Words such as “good source,” “contains” or “provides” mean there is 10-19% of the RDI or DRV per RACC. And, “more,” “fortified,” “enriched,” “added,” “extra” and “plus” mean there is a least 10% or more of the RDI for vitamins/ minerals per RACC than in a reference product. The product must also comply with fortification policy.
Structure-function claims are those basic, “building block” statements relating to the aroma, taste or nutritive value of an ingredient that describe its effect on the structure or function of the body. “The number-one statement to think about when you’re making claims is that you cannot sell a non-drug product to diagnose, treat, cure or prevent a disease,” emphasized Prochnow. A permissible statement might be, “25 grams of soy protein help support lean muscle and strength.” Per the FDA, a claim must be tied to a nutritive value. Claims not associated with the nutritive value of an ingredient, but rather the ingredient itself, are not permissible, he added.
If a food or beverage is sold with the disclaimer label stating it has not been approved by the FDA, and is not intended to diagnose, treat, cure or prevent a disease, the FDA will again assume that whoever re- viewed and approved these labels didn’t know what they were doing, as that disclaimer is only permitted on dietary supplements. While the FDA may not take specific action on the product, other than sending a warning letter, they may decide to take a closer look, Prochnow noted.
Substantiation of a claim can’t be based on personal experience, opinion or customer testimonials, but instead must rely on competent and reliable science. What then defines competent and reliable science? The Gold Standard is a double-blind, placebo-controlled, clinical trial on the product or a combination of ingredients. And, the amount of the ingredient or level of nutrient used must be the same as that used in the study. “This (policy) is often used to prevent what the FDA often calls the ‘fairy dust rule,’ which is when companies ‘sprinkle’ a small little bit of the ingredient in the product, so they can tout that it’s there, when they know there’s not actually enough in the product to provide the benefits they’re talking about,” Prochnow said.
“Whether a claim about an ingredient is on your website or your label, it represents a claim for your product as a whole, because what the FDA and the FTC say—and of course they’re right—is there’s no reason for you to be talking about those benefits, other than to imply that your product, with those ingredients, offers those bene- fits,” Prochnow added.
Most importantly, when it comes to product labeling and protein claims, you need to be well-informed. Sometimes, a food or ingredient company’s marketing department refers to our regulatory services as the “sales prevention team,” joked Prochnow. We prefer to think of our efforts as the “jail prevention team.” Either way, in- formation and accuracy keep the ball in your court, he concluded.
“Protein Quality and Labeling: Defending Attacks from Regulators, Attorneys and Competitors,” Justin J. Prochnow, Shareholder, Greenberg Traurig, LLP, www.GTLaw.com
This presentation was given at the 2018 Protein Trends & Technologies Seminar — Technical Program: Formulating with Proteins
Click here to access the PowerPoint presentation Protein Quality and Labeling Legalities by Justin J. Prochnow, Shareholder, Greenberg Traurig, LLP, www.GTLaw.com
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