Tag: FDCA

Navigating Hemp THC Beverages

Nonalcoholic beverages infused with delta-9 tetrahydrocannabinol (THC) derived from hemp (aka intoxicating hemp beverages) are becoming increasingly popular for consumers looking for an alternative to alcohol.

With major alcohol retailers like Total Wine entering the cannabis space, alcohol beverage producers may be looking for opportunities to leverage their existing experience in manufacturing, marketing and distributing alcohol beverages towards the emerging intoxicating hemp beverage market. While intoxicating hemp beverages are arguably legal pursuant to the Agriculture Improvement Act of 2018 (2018 Farm Bill), risks remain under federal and state food and drug laws. Accordingly, beverage producers looking to enter this emerging market should become familiar with the ambiguities involved.

Federal Treatment of Intoxicating Hemp Beverages

The 2018 Farm Bill removed hemp, defined as cannabis (Cannabis sativa L.) and derivatives of cannabis with extremely low concentrations of delta-9 THC (specifically, no more than 0.3 percent THC on a dry weight basis), from the definition of “marijuana” in the Controlled Substances Act. The federal government defines hemp as “the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.” Accordingly, products that meet the definition of “hemp” may be marketed and sold in the United States and are no longer classified under federal law as illegal drugs.

How Is Hemp Regulated?

Under the 2018 Farm Bill, the US Department of Agriculture (USDA) has been assigned to regulate hemp production.

However, any hemp-derived foods, including beverages, are subject to regulation by the US Food & Drug Administration (FDA) under the Food, Drug, and Cosmetics Act (FDCA). While the FDA has largely avoided enforcement actions against such products, focusing most of its efforts on products making unsubstantiated medical and therapeutic claims, it has clearly concluded that it is a prohibited act under federal law to introduce any food in the market to which THC or cannabidiol (CBD) has been added. Therefore, the risk of federal enforcement remains until the agency changes its stance towards THC as a beverage additive.

State Regulation

While the federal government has been inactive in this space, the legal status of intoxicating hemp beverage products varies significantly by state. On the one hand, several states, including Minnesota, have expressly legalized the inclusion of hemp-derived cannabinoids in beverage products, with clear regulations regarding testing, labeling, advertising and more. On the other hand, some states have legalized hemp beverage products but lack a robust regulatory framework – leading to a mostly unregulated, laissez-faire market.

Further, many states fall into a grey area when it comes to the legality of such products. Some of these states have legalized hemp along the lines of the 2018 Farm Bill but have not officially opined on whether it can be added to beverage products, while others do not mention hemp products at all. A subset of states has expressly legalized hemp in beverages, as long as it complies with federal guidance, which currently does not affirmatively allow hemp to be used as a beverage additive.

One of the most extreme measures taken by state officials to ban hemp from beverage products is currently underway in South Carolina. The state’s Department of Health and Environmental Control (DHEC) recently issued a letter to the hemp industry warning that certain hemp products are not approved to be added to beverage products, including delta-9 THC.

In its letter, the DHEC also ruled that labels and packaging may not contain references to “THC,” “CBD” or “delta-9” products, or isolates, as this implies the product is no longer a food item but is a drug and is unlawful.

This new guidance is far from outlawing cannabinoids in beverages, but it affects a growing industry that has already been promoting intoxicating hemp beverages in the state. Indeed, some beverage manufacturers in South Carolina have been forced to halt production, citing confusion over the new labeling and packaging requirements. This demonstrates how the legal landscape around intoxicating hemp beverages can change rapidly.

Finally, it is important to note that even states that expressly allow and regulate THC-infused beverage products fall into a grey area when we consider the current state of federal regulations. Until Congress acts or the FDA changes its stance towards THC as a beverage additive, we will continue seeing a patchwork of different approaches.

 
© 2024 McDermott Will & Emery
by: Alva C. Mather , Christine Dower of McDermott Will & Emery
For more on THC, visit the NLR Biotech, Food, Drug section.

New Tools in the Fight Against Counterfeit Pharmaceuticals

The explosive growth of internet pharmacies and direct-to-consumer shipment of pharmaceuticals has provided increased access to, and reduced the cost of, important medications. Unfortunately, these same forces have increased the risks that counterfeit medicines will make their way to consumers, endangering patient safety and affecting manufacturers’ reputation in the public eye.

While the Food and Drug Administration attempts to police such misconduct through enforcement of the Food, Drug, and Cosmetics Act (FDCA), the resources devoted to enforcement are simply no match for the size and scope of the counterfeiting threat. Fortunately, pharmaceutical manufacturers are not without recourse, as several well-established tools may be used in the right circumstances to stop counterfeiters from profiting from the sale of knock-offs.

Experienced litigators can use the Lanham Act and the Racketeer Influenced Corrupt Organizations (RICO) Act to stop unscrupulous individuals and organizations from deceiving customers with counterfeit versions of trademarked drugs. Until recently, these legal weapons – including search warrants, seizures, forfeitures, and significant penalties – were typically wielded only by the government and only in criminal prosecutions.

As one recent case demonstrates, however, many of the tools that law enforcement has used for years to combat counterfeiters are also available to pharmaceutical manufacturers. In Gilead Sciences, Inc. v. Safe Chain Solutions, LLC, et al., the manufacturer of several trademarked HIV medications filed a civil complaint, under seal, alleging violations of the Lanham Act and RICO against scores of individuals and companies that were allegedly selling counterfeit versions of these drugs to patients across the country.

By deploying private investigators and techniques typically used by law enforcement, Gilead was able to gather a substantial amount of evidence before even filing the case. The company then used this evidence to secure ex parte seizure warrants and asset freezes, allowing it to locate and seize thousands of counterfeit pills and packaging before they could be shipped to unsuspecting consumers. Through the seizure of the financial proceeds of the alleged counterfeiting, Gilead prevented the dissipation of assets. If the company can successfully prove its RICO case, it stands to recover treble damages and attorneys’ fees as well.

Manufacturers of trademarked pharmaceuticals may consider using these and other tools to tackle the threat posed by counterfeiters. By drawing upon the experience and skills of trained litigators – particularly counsel who previously deployed these tools on behalf of the government while serving as federal prosecutors – companies can proactively protect their intellectual property and the consumers who depend on their products.

Article By Eric J. Beste, Anthony J. Burba and Heather F. Delgado of Barnes & Thornburg LLP

For more health law legal news, click here to visit the National Law Review.

© 2022 BARNES & THORNBURG LLP

Scrutiny of Nail Salon Chemicals Raises Mass Tort Risk

Recent reports purport to link certain chemicals used in nail salon products to serious health problems such as cancer, asthma, respiratory disease, and miscarriages.  Though past efforts to impose stricter regulations on these chemicals have been largely unsuccessful, a recent slew of New York Times articles have drawn significant attention to the issue. 126504560 In response, New York Governor Andrew Cuomo issued a number of emergency regulations to protect salon workers, and New York City mayor Bill de Blasio has announced his own efforts to address the issue.  These responses could indicate a willingness on the part of lawmakers to revisit the laws regulating the cosmetics industry.

The Food, Drug, and Cosmetics Act of 1938, bans harmful chemicals from cosmetics.  The law is over 75 years old and, many believe, outdated.  It does not require FDA preapproval before chemicals are marketed, and does not mandate that chemical companies test the effects of the chemicals.  Nor does the law require cosmetic chemical manufacturers to share safety information with the FDA.  Senators Diane Feinstein (D-CA) and Susan Collins (R-ME) recently introduced a bipartisan bill that would expand FDA oversight of cosmetics.  But critics say that the bill does not go far enough because it allows the cosmetic industry to essentially continue regulating itself.  The bill may also preempt states’ ability to implement stricter regulations.

OSHA has identified at least twelve chemicals it says causes serious health problems for salon workers.  Three of these, dibutyl phthalate, formaldehyde, and toluene, which some have dubbed the “toxic trio,” have been purportedly linked to the most serious problems, such as cancer, lung and kidney failure, birth defects, and miscarriages.  These chemicals have been banned in several countries and, in others, require labels indicating the potential consequences of exposure.  No such rules currently exist in the United States.

[S]alon workers can be exposed to levels of chemicals that are legal according to OSHA but are still dangerous . . . .

In response to recent New York Times articles highlighting the working conditions of nail salon employees, Governor Cuomo issued emergency regulations to address the potential health hazards these workers face.  Thenew rules, which require manicurists to wear gloves and masks and mandate ventilation at salons, are expected to become permanent in the coming months.  NYC Mayor Bill de Blasio has also announced steps to address this issue.  In addition, NYC’s Department of Consumer Affairs has been visiting salons to collect and test products.  The Department indicated it would issue subpoenas to the manufacturers of products labeled free of a certain toxin if the product is found to contain that toxin.  The Department has also started a petition directed at the Personal Care Products Council, the cosmetic chemical industry’s main trade group, to urge its members to stop using ingredients linked to certain ailments.  The agency has sent similar letters to the FDA and OSHA.  David Michaels, the labor secretary who heads OSHA, believes OSHA’s standards are outdated and has said that salon workers can be exposed to levels of chemicals that are legal according to OSHA but are still dangerous to the workers.

The increased regulatory and media focus on the health threats facing salon workers suggests the potential for lawsuits arising from cosmetic chemical exposure.   As in other mass or “toxic tort” claims, salon worker lawsuits may involve a large number of defendants, since workers often use a variety of products made by different manufacturers.  In states that impose strict product liability on anyone in a product’s chain of distribution, nail salon lawsuits may implicate not only manufacturers, but also wholesale and retail distributors of chemical products.  As in other “toxic tort” cases, nail salon lawsuits would likely involve competing expert testimony from toxicologists, industrial hygienists, and epidemiologists regarding a numerous issues not that least of which being general and specific causation.

ARTICLE BY Jamie Lynn Lanphear & Yakov P. Wiegmann of Schiff Hardin LLP
© 2015 Schiff Hardin LLP