FDA Enforcement: Protecting Consumers and Enhancing Public Confidence

By: Howard Sklamberg, J.D. and Michael R. Taylor, J.D.

Under the Federal Food, Drug, and Cosmetic Act, companies producing food, including dietary supplement products, for American consumers have a legal responsibility to make them safe. Most companies take this responsibility seriously. FDA will work collaboratively with companies that are making a good faith effort to produce safe products and meet regulatory requirements.

The case involves Raw Deal, Inc., a manufacturer of dietary supplements based in Flanders, N.J. On September 9, Raw Deal’s owner and president, Barry Steinlight, pled guilty to one count of conspiracy to commit wire fraud involving a scheme to introduce adulterated and misbranded products into interstate commerce. Steinlight was sentenced to 40 months in prison and ordered to forfeit $1 million in profits from the fraudulent scheme.But when companies fail to meet their responsibility and violate the law in a way that jeopardizes public health, FDA can—and will—move decisively. This fall, for example, a federal court case in New Jersey illustrates the careful field work, close teamwork, and skillful investigation that are hallmarks of FDA criminal enforcement, which plays a vital role in food and dietary supplement safety.

Then, today the company’s former executive vice president, Catherine Palmer, was sentenced to a year’s probation and a criminal forfeiture of $100,000, after she pled guilty to obstructing an FDA investigation.

Last year, we wrote about federal-court convictions in the Peanut Corporation of America (PCA) case involving Salmonella-tainted peanuts and peanut products. In that case, two former officials of, and one broker for, PCA were prosecuted for practices that led to a deadly 46-state outbreak of Salmonella poisoning in 2009.

This story begins more than four years ago. Over the course of those years, FDA undertook a number of enforcement activities before criminal charges were filed by the U.S. Department of Justice:Today, we are highlighting the Raw Deal prosecution, which demonstrates our enforcement work in the dietary supplement field. The convictions arose from illegal practices by the firm, which included manufacturing adulterated and misbranded products by using fillers to cut costs, reusing returned and contaminated products, and falsifying batch records and certificates of analysis.

• In August 2011, FDA’s Office of Criminal Investigations (OCI), now headed by Director George Karavetsos, received an anonymous complaint that Raw Deal was manufacturing dietary supplements with fillers such as wheat-based products and the food additive Maltodextrin. The complainant also informed OCI that the manufacturer resold returned products that contained such contaminants as E. coli bacteria, lead and mold.
• During the OCI investigation, FDA’s Office of Regulatory Affairs’ New Jersey District Office received four anonymous letters that described Raw Deal’s adulteration scheme, including the creation of false certificates of analysis.
• The District Office conducted a compliance inspection and found that the manufacturer substituted ingredients without informing customers of the presence of fillers. As a result, the District Office issued Raw Deal a Warning Letter citing misbranding and adulteration violations.
• OCI later determined that Raw Deal did not heed this warning and instead continued misbranding and adulterating its products. OCI then obtained and executed a search warrant at the manufacturing facility, with some of the samples collected subsequently revealing the presence of Salmonella, a bacterium frequently associated with foodborne illnesses.
• This resulted in a Class I recall of certain Raw Deal products in March 2014. This recall classification means the products could cause serious health problems or death.

This case is just one example of FDA enforcement in action. Companies are given the opportunity to correct violations but if they don’t, there are serious consequences. Indeed, during the past two years, FDA criminal enforcement has resulted in 407 cases opened, 348 arrests, 305 convictions, and $694,131,579 in fines and restitutions.

Of note in this case is an excerpt from U.S District Court Judge Esther Salas’ remarks at Steinlight’s sentencing hearing:

“There is nothing more sacred than consumers having some peace of mind that people who are selling these supplements are doing it the right way, and are abiding by the laws and regulations that are put forth to protect the consumer…and my sentence has to be one that promotes respect for the law. Because what the FDA does is so critical…they are making sure that the products that we consume and the products that we use are safe for consumption, are safe for usage. And I am going to sentence you to a sentence, sir, that continues to give them the teeth they need, the power they need, to send a message to our society.”

Criminal enforcement actions protect consumers by punishing violators and deterring bad behavior by others. Strong enforcement helps industry too – by maintaining a level playing field for the production of safe foods and products.

FDA is strongly committed to working with companies that take their safety responsibilities seriously – and equally committed to dealing strongly with those that don’t.

Howard Sklamberg, J.D., is FDA’s Deputy Commissioner for Global Regulatory Operations and Policy

 

 

Michael R. Taylor, J.D., is FDA’s Deputy Commissioner for Foods and Veterinary Medicine

 

 

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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