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Accuracy in Protein Labeling: Following the Letter of the Law

Posted on:January 14, 2019
2018 PTT fwp/Accuracy in Protein Labeling: Following the Letter of the Law - Justin Prochnow
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WHEN IT COMES TO 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.

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. To download free presentations and the Post-conference summary of this event, go to https://www.globalfoodforums.com/store/protein-seminars/

See past and future Protein Trends & Technologies Seminars at https://www.globalfoodforums.com/proteinseminar/


Complications of Formulating Flavors with Protein

Posted on:January 9, 2019

NO FOOD INGREDIENT may be more influential than flavors. “We make selections about taste and preference of food based on these small sets of molecules that are barely perceptible and measurable,” said Robert McGorrin, Ph.D., CFS, Department Head and Jacobs-Root Professor, Food Science & Technology, Oregon State University, in his presentation “Protein + Flavor = A Formulation Challenge.”

Creating the right balance of flavors is especially demanding when developing high-protein foods. The addition of protein may alter the flavor by either adding off-flavor notes, such as beany or bitter types often associated with soy protein, or by causing astringency, which falls into the category of chemesthesis, producing a chemical sensation. Proteins may also change the flavor profile through flavor interactions, flavor binding or flavor release, McGorrin noted.

The type of protein can pose a challenge. “Soy, whey, casein, pea, rice, depending on how they are heated—high temperature- short time or ultra-high temperature—can bring in notes we describe as burnt, caramelized, nutty, beany, sulfuric or bitter. Amino acids also provide their own bitterness and metallic off- flavors,” said McGorrin.
Because proteins are good at binding and absorbing flavor, any sensory evaluation done on a new formulation should be delayed for at least a week to give the flavor a chance to equilibrate.

It is important to “bucketload” the formulation with flavor at perhaps four to 10 times the initial quantity needed to basically titrate the active sites on the proteins until that equilibrium point is reached, cost permitting, noted McGorrin. “You have to compensate for flavor loss.” Flavor in clear beverages may be affected by incorporating hydrolyzed protein. These systems require less flavor, because less binding occurs with these proteins, but McGorrin cautioned that more off-flavor defects may be present.

Factors, such as pH, can also influence the protein’s contribution to flavor. Beverages at a pH of 3.5 can accentuate more off-flavor defects (e.g., bitterness, astringency, chalkiness). The optimum pH to avoid a gritty texture or astringent taste is pH 6-7. However, “pH 3.5 is best with citrus beverages to make orange and lemon flavors pop,” explained McGorrin.

Flavor requirements are also dependent on the food product. For example, water activity (aw) is very influential. Protein bars have low moisture (aw= 0.2), undergo non-thermal processing and are stored at room temperature. Conversely, protein beverages are high moisture (aw = 1), are thermally processed and are stored in refrigeration. However, their flavors are unstable, because they are more reactive in solution—finding mobile sites to bind to on the protein; and flavor scalping, or muting, can also occur as protein absorbs the flavor, McGorrin noted.

Flavor masking is a technique used to minimize inherent protein off-flavors. Sweetener modifiers/enhancers or bitter blockers can often help mask off-flavors, as well. Sodium chloride, monosodium glutamate and adenosine monophosphate are examples of bitter taste receptor blockers. Vanilla or peach flavor may help mask beany notes from soy protein. Using a complementary flavor is another method used to mask off- flavors. For example, pea protein contains earthy notes. Soy has beany notes. These flavor notes are also common in peanuts, so adding peanut or nut flavors complements and helps mask these off-notes by creating flavor synergy.

Instead of masking undesirable notes, flavor completion or insertion allows these notes to become part of the flavor system. McGorrin gave the example of undesirable green notes in soy protein. By adding a “jammy-style” strawberry flavor that lacks green notes to the flavor system, the green notes inherent in soy protein complete the perception of the strawberry flavor profile.

McGorrin stressed the importance of involving the flavor supplier to reduce development time. Formulation secrets need not be revealed; but, process method, storage environment, moisture content, pH, added vitamins, presence of high-potency sweeteners and percent protein will help identify an appropriate flavor choice early on, he added.

“Protein + Flavor = A Formulation Challenge,” Robert J. McGorrin, Ph.D., CFS, Department Head and Jacobs-Root Professor, Food Science & Technology, Oregon State University

This presentation was given at the 2018 Protein Trends & Technologies Seminar. To download free presentations and the Post-conference summary of this event, go to https://www.globalfoodforums.com/store/protein-seminars/

See past and future Protein Trends & Technologies Seminars at https://www.globalfoodforums.com/proteinseminar/


Proposed Non-GMO Labeling and Certification Options

Posted on:January 8, 2019
2018 PTT fwp/Proposed Non-GMO Labeling and Certification Options - Nancy Knight

Non-GMO Project is a highly recognized and trusted verification process. Of noted importance is that some of the newer technologies, such as CRISPR-Cas9 (gene editing), will not be able to be certified under the impending bioengineered standard.

WHILE NON-GMO claims are fast growing, the regulatory land- scape is unclear. Nancy Knight, Director of Quality and Regulatory Compliance, Orgain, Inc., discussed current challenges, as well as options for non-GMO labeling in her presentation “Non-GMO Transparency: Understanding Your Options.”

The final rule for the National Bioengineered (BE) Food Disclosure Law is expected to be issued later this year. The Agricultural Marketing Service of USDA comment period ends July 3, 2018. Federal law preempts state law. Knight encourages companies whose brands might be affected to read the lengthy rule.

USDA is silent in the regulation regarding third-party, non- GMO certifications. The proposed rule requires GMO ingredients to be labeled if they ARE in the product. Third-party certifications indicate that GMO ingredients AREN’T in the product. Whether the two approaches to labeling will align is still a grey area.

FDA’s guidance for voluntary labeling was issued November 2015. Certain terms are recommended, such as “not genetically engineered,” “not bioengineered” or “not genetically modified using modern biotechnology.”

The guidance emphasizes avoidance of “GMO-free” claims and to avoid intervening material in the list of ingredients, such as “non-GMO corn.” Knight reasoned that FDA views this as a gateway labeling violation. “In (and of) itself, it’s not that big of a deal,” she said, “but it may indicate that you have people on your staff who don’t know much about labeling.”

Companies seeking non-GMO verification have choices. The nonprofit Non-GMO Project is highly recognized. Their logo has earned consumer trust and retail promotion. They stand by their standards. “The Non-GMO Project thought it important that I state that they are looking at new technologies [used by the industry],” she said. CRISPR and novel technologies will not be able to be certified under the standard.

The process to achieve certification begins with selecting a technical administrator (TA) who is affiliated with an outside agency. The Non-GMO Project requires a license agreement. The TA will complete a product evaluation. Once verified, products will be eligible for marketing. Verification is renewed annually. She cautions it can take four weeks or (up to) a year and a half to get through the process.

“I can’t stress enough how the key to success is partnering with the right TA. Everyone has a different competency. If you [use] citric acid, for example, see if they have certified citric acid before.” TAs must understand how products are made, so it can avoid a lot of education and loss of time if they’ve worked with the product before.

Food Chain ID, NSF, Where Food Comes From and SCS Global are all TAs. Food Chain ID has the longest history of verification. She recommends interviewing the TAs, getting pricing and negotiating. “If you’re big enough, say you want a project manager. Tell them your timeline. The flip side is, make sure someone in your organization is up to speed on the standards and knows what type of documentation is required,” she said.

Other options to the Non-GMO Project include USDA Organic and USDA Process Verified. NutraSource I-Gen, a testing lab, is another alternative with fewer documentation requirements. NSF True North was created in collaboration with Whole Foods. Available to other companies, its advantage is ease of certification if already organic.

Some companies do not follow a certification route and use their own logos. This is acceptable, as long as it meets FDA’s definition of what is truthful and not misleading. Some retailers require third-party certification.

Nevertheless, USDA guidance is coming. “You don’t want to go down the path of a third-party certification that may be inconsistent,” she cautioned. “Some companies, like Whole Foods, are pausing until the rule is clear. They still want third-party verification, but ingredient statements might be affected by the rule.”

“Non-GMO Transparency: Understanding Your Options,” Nancy Knight, Director of Quality and Regulatory Compliance, Orgain, Inc.

This presentation was given at the 2018 Protein Trends & Technologies Seminar. To download free presentations and the Post-conference summary of this event, go to https://www.globalfoodforums.com/store/protein-seminars/

See past and future Protein Trends & Technologies Seminars at https://www.globalfoodforums.com/proteinseminar/


The Value of Protein on Muscle Health During Aging

Posted on:January 3, 2019

RECENT ADVANCES in research show protein’s potential to improve health status in aging adults, according to Douglas Paddon-Jones, Ph.D., FACSM, Department of Nutrition and Metabolism; Center for Recovery, Physical Activity and Nutrition; The University of Texas Medical Branch, Galveston, who spoke on the topic “Nutrition Strategies to Protect Muscle Health During Aging: The Value of Protein.” The most effective interventions to reduce muscle loss during aging include physical activity, overall nutrition and protein, he stated.

Paddon-Jones’s research has shown that the ingestion of sufficient protein is important for muscle protein synthesis (MPS) and maintenance of muscle mass and function. He described a study that looked at MPS in healthy young (41 years +/- 8) and elderly (70 years +/- 5) adults (Symons, TB et al. 2007. Am J Clin Nutr./ https://bit.ly/2yu8Gt7). Basal MPS was measured prior to and after the consumption of a 4oz serving of lean beef containing 30g of protein. “Very encouraging results showed that decrements in MPS did not occur in the elderly,” noted Paddon-Jones. “There was a 50% increase in MPS, suggesting that aging doesn’t impair the ability of the body to build and repair muscle.”

Recognizing that typical intakes of protein are much greater than 30g, further research sought to compare changes in MPS following a single moderate serving (113g; 220Kcal; 30g protein) or large serving (340g; 660Kcal; 90g protein) of lean beef in young and elderly adults (Symons et al. 2009. J Am Diet Assoc./ https://bit.ly/2tg5yfm). Despite a threefold increase in protein and energy content, there was no further increase in MPS. “This is a powerful example that suggests an ‘intake ceiling’ of 30g of protein for optimum muscle building,” he said.

The synergistic effects of resistance exercise and a protein-rich meal on MPS has been evaluated (Symons, TB, et al. 2011. J Nutr Health Aging./ https://bit.ly/2u3xi6s). Following ingestion of 340g lean beef and resistance exercise (knee extensions) in healthy young (29 years ±3) and older (67 years ±2) adults, Paddon-Jones reported that “the results were encouraging, as muscle building increased by approximately 108% in young and older adults following the protein and resistance exercise.”

“Our research suggests that protein intake should be optimized at every meal to positively impact MPS,” noted Paddon-Jones, “If you are consuming 65g of protein at dinner, your muscle is only using 50% of this.” His research has also shown that MPS is blunted in the elderly, when the quantity of protein is less than about 20g per meal (Paddon-Jones D and Rasmussen, BB. 2009. Curr Opin Clin Nutr Metab Care. / https://bit.ly/2s6ClC1).

Bed rest has a profoundly negative effect on muscle metabolism, mass and function in adults. In one study, patients remained in bed 95% of the time over four days with no activity. The remaining 5% of the time involved only about 15 steps per minute, resulting in rapid muscle atrophy. Middle-aged adults showed few phenotypic signs of aging, yet they may be more susceptible to inactivity than younger adults (English et al. 2016, Am J Clin Nutr./ https://bit.ly/2K6LO7z). “We need to start focusing on muscle health the same way as we do bone health,” Paddon-Jones stressed.

Nutrition is one area where a difference can be made. Paddon-Jones’s research also examined whether leucine, a branch-chain amino acid and stimulator of skeletal MPS, can protect skeletal muscle health during bed rest (English et al. 2016 / http://bit.ly/2OqoSC8). Middle-aged adults (52 years ± 1) were supplemented with leucine (0.06g/kg/meal or about 4g/meal) or an alanine control during 14 days of bed rest. Bed rest decreased post-absorptive MPS by 30% ± 9% (Control group) and by 10% ± 10% (LEU group). Leucine protected knee-extensor peak torque and endurance. “Interestingly, leucine prevented an increase in body fat percentage and reduced whole-body lean mass loss after seven days,” noted Paddon-Jones, “but not at 14 days of bed rest. Perhaps leucine supplementation could partially protect muscle health during relatively brief periods of physical inactivity,” he concluded.

“Strategies to Protect Muscle Health During Aging: The Value of Protein,” Douglas Paddon-Jones, PhD, Professor, Department of Nutrition and Metabolism, The University of Texas Medical Branch

This presentation was given at the 2018 Protein Trends & Technologies Seminar. To download free presentations and the Post-conference summary of this event, go to https://www.globalfoodforums.com/store/protein-seminars/

See past and future Protein Trends & Technologies Seminars at https://www.globalfoodforums.com/proteinseminar/

 


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