The Dietary Supplement Health and Education Act of 1994 (DSHEA) laid the foundation for colossal growth in the natural products industry.
That’s obvious to the industry.
Perhaps less evident is the fact that DSHEA does not operate in a vacuum. Just like the 3-year-old FDA Food Safety Modernization Act (FSMA), DSHEA constituted an amendment to the Federal Food, Drug and Cosmetic Act (FD&C) and gave FDA broader authority to remove dangerous products from the market.
"The concept of adulterated and misbranded, they go back to the 38 Act," Marc Ullman of the law firm Ullman, Shapiro & Ullman, LLP said, referencing the FD&C of 1938. "Those concepts apply as does the concept of criminal liability for selling adulterated or misbranded foods, drugs and cosmetics."
The FD&C defines an adulterated food, in part, as a food that “bears or contains any poisonous or deleterious substance which may render it injurious to health." A misbranded product is essentially one that is mislabeled, reflecting a discrepancy between the label and the actual contents. For instance, labels that are “false or misleading" are considered misbranded under the FD&C.
Peter Barton Hutt of Covington & Burling LLP, legal counsel to the Council for Responsible Nutrition (CRN), cited erroneous beliefs that DSHEA eliminated the food-safety standards under the FD&C.
“In fact, DSHEA did not alter the basic food safety provision in the FD&C Act that has prohibited any poisonous or deleterious substance in food since 1906," he wrote in a white paper that he updated in 2011 for CRN.
DSHEA expanded the definition of “adulteration" under the FD&C to include, in part, dietary supplements containing “a dietary ingredient that presents a significant or unreasonable risk of illness or injury under conditions of use recommended or suggested in labeling, or if no conditions of use are suggested or recommended in the labeling, under ordinary conditions of use."
The U.S. government bears the burden of establishing a dietary supplement is adulterated. This is the same burden of proof applicable to conventional foods, Hutt pointed out.
That means FDA must seek relief in the federal courts before it can take enforcement action against an adulterated product. At least 10 days before FDA refers a matter to the U.S. Department of Justice for civil court enforcement, the agency must first grant a company an opportunity to present its viewpoint, Hutt observed.
But what if FDA needs to take swift action against a dietary supplement firm to prevent imminent harm to the public? Section 4 of DSHEA granted FDA an opportunity to immediately remove dangerous supplements from the market under limited circumstances: through a finding by the Secretary of Health that a dietary supplement poses “an imminent hazard to public health or safety."
“This administrative determination results in an immediate ban of the ingredient or product," Hutt wrote in the white paper. “There is no comparable authority for conventional food."
The FD&C is sometimes referred to as a “strict liability statute," which means prosecutors need not show that the offender intended to commit a prohibited act under the law. Placing an adulterated food—including a dietary supplement—into interstate commerce constitutes such a forbidden act, subjecting the offending party to potential criminal prosecution.
“All FDA really has to show is that when you put the offending product into interstate commerce, you weren’t in a coma," Ullman said.
Consider the deadly Listeria outbreak tied to a cantaloupe farm in Colorado. Last year, the U.S. Attorney’s Office in Denver brought criminal misdemeanor charges against two brothers, Ryan and Eric Jensen. The 2011 case marked one of the largest outbreaks of listeriosis in U.S. history, causing 147 illnesses in 28 states, including 33 deaths and one miscarriage.
Prosecutors never alleged that the defendants intended to place contaminated cantaloupes on the market. In fact, Assistant U.S. Attorney Jaime Pena told a federal judge during the Jensens’ sentencing hearing that the fourth-generation farmers “didn’t intend to hurt anybody."
In January 2014, U.S. District Court Magistrate Judge Michael Hegarty sentenced each brother to five years of probation, $150,000 in restitution, 100 hours of community service and six months of home detention after the Jensens pleaded guilty to six counts of adulteration of a food and aiding and abetting.
The result could have been much worse. The criminal charges carried penalties of up to six years in prison and $1.5 million in fines.
FDA, through the U.S. Attorney’s Office, has brought criminal prosecutions sparingly.
“Those kinds of cases are pathetically few and far between," Ullman said. “The FDA is supposed to be a law enforcement agency. Law enforcement only works when there is an element of deterrence."
Still, the FD&C of 1938, DSHEA and FSMA make it clear that FDA has an ample arsenal of tools to protect public health and deter unlawful behavior. Supplement firms shouldn’t gamble on the odds that FDA won’t use them more often.