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As lawyers allege adulteration is rampant, APHA urges FDA to change guidelines on how proteins in food are defined

Joysa Winter

December 1, 2014

9 Min Read
Lawsuits Target “Protein Spiking”

Adulteration is rampant in the protein market. And after years in the dark, consumers and lawyers are calling manufacturers out in class-action lawsuits that could be just the start of an industry shakeout.

Frank Jaksch, cofounder and CEO of the analytical testing company ChromaDex, says as many as 50 percent of all the protein products he has tested have shown evidence of adulteration. While Jaksch is quick to point out that those findings are for just 50 percent of what he’s tested and not necessarily representative of the entire market, they still point to a troubling lack of purity.

The method in question is known as “protein spiking,” “amino spiking,” or “nitrogen spiking.” It involves the addition of inexpensive free-form amino acids and non-protein ingredients to increase a supplement’s nitrogen content. Since standard tests use nitrogen levels as an indirect measure of protein content, such manipulation lets manufacturers cut costs associated with whey protein while still passing the tests.

But whey protein is a complete protein source that contains all of the essential amino acids necessary for building muscle tissue, skin, hair, and fingernails. “Individual amino acids are not a substitute for protein,” Jaksch says. “Individual amino acids can be added to a product and, depending on the qualities of that individual acid, it could confer some other benefits. But free-form aminos do not act as proteins in the body.”

The first class-action lawsuit over protein spiking was filed in August in New York. A second, by the same legal team, was filed in October. Nick Suciu III of Barbat, Mansour & Suciu, the lawyer leading both cases, says he has up to 10 more in the works. And while he says he isn’t aware of any other law firms pursuing similar actions, copycat lawsuits are common in the class-action world. So these current cases could be just the tip of the iceberg.

 “We’ve known this has been going on for about four years,” says Anthony Almada, president and CEO of GENR8, a sport-nutrition company. “It’s been the industry’s dirty little secret. This is why the notion that industry will police itself is bogus. Economic interest is always protected before consumer interest.”

The first suit was filed against United States Nutrition Inc., Healthwatchers Inc., and parent company NBTY Inc., alleging that Body Fortress Super Advanced Whey Protein contains less protein than advertised. NBTY is a company behind many popular and respected brands, including Vitamin World, Solgar, Balance Bar, Ester-C, and Puritan’s Pride.

The plaintiffs are six men from Colorado, Florida, Pennsylvania, Oregon, Kentucky and South Carolina, who purchased the protein supplement at various stores in their home states over several years, according to the lawsuit filed in the U.S. District Court for the Eastern District of New York, where NBTY is based. They are seeking class certification and compensatory damages and are represented by Suciu; Jonathan Shub of Seeger Weiss LLP; and Jordan L. Chaikin of Parker Waichman LLP.

The complaint states that the company features “the name of the ingredient sought by millions of American consumers, ‘whey protein,’ by predominantly featuring it … on the [product] containers.” The packaging claims that the product delivers 30 grams of protein per serving, yet the suit states that scientific testing showed the actual content to be just 21.5 grams of protein per serving once spiking agents were removed.

This, the lawsuit states, violates trade-practice and consumer-protection laws in multiple states.

 “The whey protein industry is a growing and extremely competitive business environment,” the complaint reads. “However, the price of wholesale whey protein keeps increasing and is usually purchased for roughly $15-$18/kilo., making the profit margins on whey protein very low.”

The second class-action suit, filed in California, claims that Giant Sports Delicious Protein contains 60 percent less protein than advertised and that it is spiked with amino acids and other nonprotein compounds, such as creatine monohydrate.

Giant Sports is a New Jersey-based company selling bodybuilding and weight-loss products under the tag line “superior sports nutrition.” According to its website, the company is GMP-certified.

For Suciu, the lawsuits grew out of personal interest. A bodybuilder and self-described gym rat, Suciu started his legal work in the dietary supplement world on the other side of the aisle, defending manufacturers against lawsuits. But within a few years, his sympathies shifted.

“I represented bodybuilding supplement companies in a few class actions,” Suciu says. “That’s what gave me the idea to go the other way in terms of doing class-action work. I learned a lot about the science during my time there, and I thought I could do a better job on the scientific side working with plaintiffs. I’ve been lifting and had that lifestyle for a while, and when I learned what was going on, it was troubling to me.”

Whey Protein

One of the issues at the heart of these lawsuits is the rising price of whey protein, a once worthless dairy byproduct that now powers a massive industry sector, valuable both to animal-feed purchasers and as a food ingredient. Wisconsin’s 113-year-old Alto Dairy used to spread it on fields as a fertilizer but now sells the 80 million pounds of whey it produces at its cheese plant every year for about $0.70 per pound, double what it was selling for just four years ago. That rise is attributed in part to growing demand in Asia.

“The increasing price and the fear of actual lack of material in the future are pushing the large milk protein uses in sports and infant nutrition to look for other options to replace the preferred proteins, even if only partly,” says a 2013 story on HealthGauge.com. “This has resulted in increased use of vegetable proteins in the sports nutrition segments over the last years…The price for pea protein concentrate has gone up 30 percent in the last months, reaching prices above €5.00 ($6.24) a kilogram. It is mainly the lack of material of European source that is pushing prices up.”

Some relief might be on the horizon

“Compared to a year ago August, exports were 20 percent lower for dry whey, 36 percent lower for whey protein concentrate and 11 percent lower for lactose,” HealthGauge.com says. “But cheese was still 11 percent higher. Due to increase in world milk production and China’s much lower dairy imports than earlier in the year, world dairy product prices have declined substantially and are considerably lower than U.S. prices, lowering U.S. exports.”

But Chromadex’s Jaksch doesn’t share the optimism that whey prices are going to let up anytime soon. “Why would they?” he asks. “There’s no reason for them to go down. We keep seeing an increase in demand; protein has become synonymous with healthy weight loss; its use is expanding. This is a trend I see just based on the number of calls we get of people trying to enter the market.

“People call us every day, literally from all over the world. People who don’t have protein ingredients who are trying to break in; people who have new novel proteins they think will change the protein game. Protein demand isn’t going down anytime soon.”

How Spiking Works

Manufacturers are able to cut costs with spiking Jaksch says, because the industry standard for measuring protein levels—known as the Kjeldahl nitrogen test—is easily fooled. According to John Travis, senior research scientist at NSF International, “The Kjeldahl method involves liberating reduced nitrogen as ammonia and then measuring the ammonia. Since this test determines the nitrogen content, it is used to calculate the total grams of protein in a protein supplement. The Kjeldahl test could imply a given supplement contains more whole protein than it actually does if the test measures a non-protein substance simply by its nitrogen content.”

Jaksch points out that it was a reliance on nitrogen testing that led to the 1998 melamine scandal. Back then, product manufacturers, particularly in China, began adding melamine, a nitrogen-rich chemical sometimes used as fertilizer, to infant formula, wheat gluten, rice protein concentrate, and corn gluten without setting of test alarms.

“When something passes the Kjeldahl method, all that tells you is that you have something in your product with a certain amount of nitrogen in it,” Jaksch says. “That has some value only as long as you are doing other tests to prove the identity of your protein. At the root of all protein-spiking is the fact you are using a nonspecific test to measure protein.”

Which describes exactly how protein-product manufacturers are tricking the test. By adding inexpensive, nitrogen-rich free-form amino acids, they make the total protein content look higher than it actually is.

Top amino spiking agents include arginine, which has three times more nitrogen than whey protein, and creatine, which has 1.5 times more nitrogen at less than half the price of whey protein, according to Tim Ziegenfuss, CEO of the Center for Applied Health Sciences, a clinical research group.

A Simple Fix

It isn’t as if coming up with an alternate test would be that expensive. While no single group has proposed a specific named test to replace Kjeldahl’s, groups like Chromadex can run a series of tests on a product sample that determines: the source of the protein, its bound and unbound amino acid profile, and the nitrogen content.

“A deep-dive study like that costs only $250 to $500 and takes about 10 days for the finished results,” Jaksch says.

The American Herbal Products Association (AHPA) is the first trade association to recognize a need for clarity in how protein is labeled. In April, four months before the first class-action lawsuit made its way to court, the association issued guidance on the labeling of protein in food and dietary products, seeking to establish a standard for measuring protein content in food products.

“AHPA’s work in this matter started with the realization that FDA had written a regulation that is unclear, since it states that the amount of protein in a food or supplement may be calculated as a factor of the product’s nitrogen content,” said AHPA President Michael McGuffin. “But there are nitrogen sources that are not protein, which can lead to errors when calculating protein, even if in complete compliance with FDA’s rule.”

The AHPA guidance defines protein as “a chain of amino acids connected by peptide bonds” and recommends that the protein content of foods and dietary supplements should be calculated based on that definition, and that non-protein nitrogen-containing substances should not be included in that calculation. AHPA encourages all supplement makers to adopt this standard of measuring their protein content.

Sports nutrition giant Dymatize of Texas is one of the protein manufacturers who, from the beginning, has been supportive of AHPA’s efforts.

“Since many free amino acids and creatine cost less to formulate with than intact protein, this creates an opportunity for products containing less real protein to be lower priced and thus more attractive on the retail shelf,” explains Robert Wildman, AHPA's chief science officer. “However, I have to believe that when the consumer buys a protein product with a specific protein claim, they think it is coming from the protein(s) in the ingredient listing.”

Good news could be on the horizon for consumers. According to Wildman, the FDA will be amending labeling guidelines next year. The agency could take that opportunity to say that protein listed on labels should come only from intact proteins, thus ruling out spiking from a regulatory standpoint instead of leaving it up to the courts.

About the Author(s)

Joysa Winter

Joysa has been reporting on the healthy foods and dietary supplements industry for more than a decade. She is a graduate of the University of Missouri-Columbia School of Journalism and has a master's degree in Hebrew Letters.

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