The U.S. Food and Drug Administration (FDA) is investigating companies that produce and sell poppy seeds due to growing concerns over contamination with a controlled substance. In doing so, it is collaborating with the Drug Enforcement Administration (DEA) and the Federal Bureau of Investigation (FBI). There is evidence to suggest that multiple individuals have died as a result of the suspected contamination, and there is a high likelihood that the FDA will continue its investigative efforts until it is able to identify and take action against the source of the problem.

Concerns about poppy seed contamination are not new. The plant that produces poppy seeds, Papaver somniferum (commonly known as the breadseed poppy or opium poppy), also produces the opiates morphine and codeine. These opiates are not present in poppy seeds themselves, however poppy seeds can become contaminated with morphine and codeine during the harvesting process.

What is unique about the FDA’s current investigation is that the agency is not concerned about contamination during harvesting. Instead, the concern appears to be that poppy seeds are being laced with an as-yet-unidentified controlled substance. This is a much more serious allegation (although companies targeted for inadvertent contamination can also face severe consequences), and it is one which has raised significant concerns for federal authorities.

“We’ve seen opioid contamination cases involving poppy seeds before. However, the FDA’s current allegations, that one or more parties are intentionally lacing poppy seeds with a controlled substance, are new. These are serious allegations, particularly since there are concerns that the laced poppy seeds may be causing death. Any individuals or companies charged as a result of the FDA’s investigation can expect to face substantial penalties.” – Dr. Nick Oberheiden, Founding Attorney of Oberheiden P.C.

At this stage, relatively little is known about the specific focus of the FDA’s collaborative effort with the DEA and FBI. However, it is clear that these agencies are devoting substantial resources to the effort, and it also appears to be the case that the majority of the work is being done out of the FDA’s field offices in Miami and Los Angeles.

FDA Oversight of the Poppy Seed Industry

The FDA holds primary responsibility for overseeing the poppy seed industry in the United States. As a food, poppy seeds fall squarely within the FDA’s jurisdiction, and the FDA has authority over the use of morphine and codeine (and other opiates) for medical purposes as well.

Historically, the FDA has focused its efforts on preventing the sale of poppy seeds contaminated with morphine and codeine due to inadequate washing and processing. It has also targeted companies for making false claims about poppy seeds’ medicinal qualities. As the current wave of investigations potentially involves both poppy seeds and controlled substances falling outside of the FDA’s wheelhouse, it makes sense that the DEA is involved. The FBI’s involvement further signifies the severity of the allegations at hand, as well as the potential for charges that are not related specifically to companies’ production and sale of contaminated poppy seeds.

Prosecution Risks for Companies that Produce and Sell Laced Poppy Seeds

Indeed, individuals and companies targeted in the FDA, DEA, and FBI’s ongoing investigative efforts could potentially face a multitude of serious federal charges. Based on what is known so far, it appears that possible charges could include:

• Adulteration of a Food – Adulteration of a food is a federal offense that carries fines and federal prison time. Even if not directly involved in the adulteration process, companies, their owners and executives, and even their personnel could face charges for aiding and abetting.
• Drug Distribution – Distribution of controlled substances is a federal crime under 21 U.S.C. Section 841. Penalties under Section 841 are determined based upon the specific drug and quantity distributed. In cases involving alleged large-scale drug distribution (such as those currently under investigation), defendants can easily face multi-million-dollar fines and decades of federal imprisonment.
• Conspiracy to Distribute Drugs – Under 21 U.S.C. Section 846, defendants who participate in a conspiracy to distribute drugs can face the same penalties as those who are directly involved in the drugs’ distribution. In cases such as those currently under investigation, federal prosecutors frequently use conspiracy charges to cast a wide net and target multiple defendants.
• Conspiracy to Defraud Consumers – Conspiracy to defraud consumers is a federal charge that falls within the FDA’s enforcement jurisdiction. Selling laced poppy seed products with inadequate labeling could lead to such a charge for all parties involved.
• Conspiracy to Defraud the FDA – Companies and individuals that sell adulterated poppy seed products could also face charges for defrauding, or conspiring to defraud, the FDA. Under 18 U.S.C. Section 1001, making false statements to a federal agency or concealing material information from a federal agency is a crime that carries statutory fines and up to five years of federal imprisonment.
• Wrongful Death (“Death By Distribution”) – If laced poppy seeds are in fact resulting in fatal overdoses as suspected, those involved could also conceivably face wrongful death charges. In drug overdose cases, prosecutors will often pursue wrongful death charges based on the theory of “death by distribution.”

Defense Strategies for Companies Targeted By the FDA, DEA, and FBI

Regardless of the specific allegations at issue, companies targeted by the FDA, DEA, and FBI for selling laced poppy seeds will need to execute a strategic and rigorous defense. These investigations are likely to move swiftly, and prosecutors will be prepared to aggressively pursue charges when they have the evidence they need.

With regard to specific defense strategies, the options that companies (and their owners, executives, and personnel) will have available will depend on the specific allegations at issue. In some cases, asserting lack of knowledge and intent may be a viable defense strategy—if those targeted were truly unaware of what was being done. However, constructive knowledge is enough to warrant federal criminal prosecution in many cases, so defendants and their counsel will need to be very careful when choosing the defenses they put forward.