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Higdon, Jr. announced that a federal grand jury has returned a 41-count Indictment, charging ABHISHEK KRISHNAN, owner of American Pure Whey, LLC, of mail fraud, introducing adulterated and misbranded foods into interstate commerce, and money laundering. The Indictment seeks forfeiture of approximately six million dollars and several Raleigh, North Carolina real properties. According to the Indictment, American Pure Whey sold protein powders in bulk to other dietary supplement manufacturers and in retail quantities to the public. Other dietary supplement suppliers purchased American Pure Whey products, but packaged them with their own labels, similarly reflecting high protein and low carbohydrate content. The American Pure Whey products were manufactured and packaged in New Bern, North Carolina. KRISHNAN promoted the products on the website, www.americanpurewhey.com, which claimed the company followed strict quality control standards to produce the highest quality protein powder. In a single 33 gram serving, the website represented that the protein powder products contained as high as 29 grams of protein and as low as 1.58 grams of carbohydrates. The labels affixed to the products manufactured by American Pure Whey also represented the high protein and low carbohydrate amounts. The Indictment alleges, however, that contrary to the representations on American Pure Whey’s website and on the product labels, the protein powder products manufactured and sold by American Pure Whey contained markedly lower protein and significantly higher carbohydrate contents in order to fraudulently increase the companies’ profit margin. The Indictment further alleges that between August 2015 and December 2018, U.S. Food and Drug Administration (FDA) agents acting in an undercover capacity and posing as consumers made six purchases on American Pure Whey’s website of various types of protein powder products. FDA analysis for protein and carbohydrate contents revealed significantly less protein and substantially more carbohydrates per serving than represented on the respective labels. For example, the 100% Whey Protein Isolate, cake batter flavor, purchased in December 2018, contained only ten grams of protein when the label declared 29 grams per serving. Further, there was 27 grams of carbohydrates when the label represented just 1.58 grams per serving. The Indictment also alleged that contrary to KRISHNAN’S statements about American Pure Whey’s strict quality control standards, APW lacked basic quality control procedures in the manufacturing, packaging and labeling of APW products. The Indictment further describes KRISHNAN and American Pure Whey’s past interactions with the United States Food and Drug Administration (FDA), which conducted three regulatory inspections of American Pure Whey’s facilities between September 2015 and July 2019. At the close of each inspection, the FDA observed and noted numerous deficiencies in American Pure Whey’s manufacturing processes and procedures, including repeated issues with APW’s master manufacturing and batch production records. In addition, the FDA sent a Warning Letter to KRISHNAN in May 2016, informing him that all of American Pure Whey’s protein powder products were adulterated because they were manufactured under conditions that did not conform to current good manufacturing practice, and at least one product was misbranded because FDA analysis revealed that the product contained less than half the amount of protein declared on the label. KRISHNAN repeatedly responded to the FDA stating that he would take corrective actions to address the deficiencies. Mr. Higdon commented: “This case is about honesty and integrity when offering a product to the public. And those principles are critical when a manufacturer offers food and dietary products. The FDA and the Justice Department are committed to ensuring that the public knows what it is getting when it purchases products of this sort. And we are committed to prosecuting those who willfully ignore the law.” “American consumers rely on the FDA to ensure that their foods, including dietary supplements, are safe, wholesome, and properly labeled. When criminals manufacture and sell adulterated and misbranded dietary supplements, they not only cheat consumers, but also place the U.S. public health at risk,” said Justin C. Fielder, Acting Special Agent in Charge, FDA Office of Criminal Investigations, Miami Field Office. “FDA remains fully committed to pursuing and bringing to justice those who ignore the law.” Investigation of this case was conducted by the FDA, Office of Criminal Investigation, and the United States Department of Homeland Security. The prosecution is being handled by Assistant United States Attorney Susan B. Menzer and Special Assistant United States Attorney and FDA Associate General Counsel Shannon M. Singleton. The charges and allegations contained in the Indictment are merely accusations. The defendant is presumed innocent unless and until proven guilty in a court of law. Component(s): USAO - North Carolina, Eastern Content current as of: 08/12/2019 Press Releases Footer Links FDA Archive About FDA Accessibility Visitor Information Website Policies / Privacy No FEAR Act Vulnerability Disclosure Policy FOIA HHS.gov USA.gov Contact FDA Follow FDA on Facebook Follow FDA on Twitter View FDA videos on YouTube Subscribe to FDA RSS feeds FDA Homepage Contact Number 1-888-INFO-FDA (1-888-463-6332) Back to Top