By: Jessica Wasserman, Esq.
As part of the ongoing vaping illness issue, on Friday the US Food and Drug Administration (FDA) strengthened its warning to consumers and issued a statement advising consumers to avoid all THC containing-vaping liquids. The Center for Disease Control (CDC), the federal agency that is on the front lines for any threat to public health, works closely with FDA and state health departments to gather data and then communicates risk to the public.
In these early stages of the investigation into what, exactly, is causing lung injury in vape users, we are left with more questions than answers. CDC reports that most, but not all, victims of respiratory illnesses linked to vaping appear to have used vaping liquids made with tetrahydrocannabinol, or THC, but it is unclear if other cannabinoids were also consistently present. Reportedly, most of the vapes also contained what the agency is referring to as “significant amounts” of vitamin E acetate.
Right now, say investigators, it isn’t clear whether the THC, the vitamin E ingredient or something else is the problem. FDA is urging consumers not to buy vaping products off the street and not to add any substances, including THC, to their vaping liquids until the source the product causing the illnesses is identified. At this stage of the investigation it remains unknown if THC is the cause of the respiratory illnesses being reported, and no one brand, seller, manufacturer, or country of origin has been singled out as a potential source.
How FDA and CDC move forward on this case will depend on whether or not they can pinpoint a source and when the “outbreak” subsides. The investigation is complex because it involves 48 states and over 1,000 impacted consumers. According to FDA, “The outbreak is occurring in the context of a dynamic marketplace for e-cigarette, or vaping, products, which may have a mix of ingredients, complex packaging and supply chains, and include potentially illicit substances. Users may not know what is in their e-cigarette or e-liquid solutions. Many of the products and substances can be modified by suppliers or users. They can be obtained from stores, online retailers, from informal sources (e.g. friends, family members), or “off the street.””
What to Expect Next:
FDA responds to dozens of similar events annually, such as the recent outbreaks and recalls around romaine lettuce and prior to that, peanut butter. Recalls occur when an identifiable source can be associated with a risk to human health and the company either voluntarily conducts a recall or is prompted by FDA.
Recalls are almost always voluntary. Sometimes a company discovers a problem and recalls a product on its own. Other times a company recalls a product after FDA raises concerns. Only in rare cases will FDA request a recall. But in every case, FDA’s role is to oversee a company’s strategy and assess the adequacy of the recall.
FDA first hears about a problem product in several ways:
A company discovers a problem and contacts FDA.
FDA inspects a manufacturing facility and determines the potential for a recall.
FDA receives reports of health problems through various reporting systems.
The Centers for Disease Control and Prevention (CDC) contacts FDA.
FDA uses public alerts and seeks publicity about a recall only when it believes the public needs to be alerted to a serious hazard. When a product has been widely distributed, the news media is used to reach large numbers of people. FDA can hold press conferences, issue press releases, and post updates to its website regularly, to alert people.
Product Recalls
FDA products subject to recall include:
human drugs
animal drugs
medical devices
radiation-emitting products
vaccines
blood and blood products
transplantable human tissue
animal feed
cosmetics
about 80 percent of the foods eaten in the United States
In the case of the vape investigation, FDA and CDA are following the contours of a foodborne illness investigation:
Epidemiologic Data:
Patterns in the geographic distribution of illnesses, the time periods when people got sick.
Foods or other exposures occurring more often in sick people than expected.
Clusters of unrelated sick people who purchased at the same retail outlet or attended the same event.
Traceback Data:
A common point of contamination in the distribution chain, identified by reviewing records collected from locations and stores where sick people purchased product.
Findings of environmental assessments in production facilities, farms, and events identifying food safety risks.
Products and Environmental Testing Data:
The chemical or ingredient that caused illness found in a food item collected from a sick person’s home, a retail location, or in the food production environment.
The same DNA fingerprint linking germs found in foods or production environments to germs found in sick people.
The goal is to pinpoint the cause and eliminate it. Health officials don’t solve every outbreak. Sometimes outbreaks end before enough information is gathered to identify the likely source.
Ongoing Investigation
Ongoing CDC investigation activities:
CDC is working 24/7 to identify the cause or causes of this outbreak through partnerships with states and other federal agencies.
CDC has activated the Emergency Operations Center (EOC) to coordinate activities and provide assistance to states, public health partners and clinicians around the nation.
CDC’s Lung Injury response efforts are committed to:
Identify and define the risk factors and the source for lung disease associated with e-cigarette product use, or vaping.
Detect and track confirmed and probable cases in the US.
Communicate actionable recommendations to state, local, and clinical audiences.
Establish lab procedures that can assist with the public heath investigation and patient care.
CDC continues to work closely with FDA, states, public health partners, and clinicians on this investigation by providing consultation and technical assistance to states on communication, health alerts, public outreach, and surveillance.
CDC is maintaining an outbreak webpage with key messages and weekly updates on case counts, deaths, and resources.
CDC is holding congressional briefings, media telebriefings, and regular calls with health departments, clinicians to provide timely updates.
CDC worked with states to create a case definition [cdc.gov] to classify confirmed and probable cases in a consistent way. States are in the process of classifying patients. We expect that states and clinicians may look back for past lung injury cases based on CDC’s case definition CDC will report numbers of confirmed and probable lung injury cases once states have finalized their classification of cases.
By invitation, CDC has deployed Epidemic Intelligence Service (EIS) officers to states to conduct Epi-Aids.
CDC has started collecting and testing clinical lab specimens to learn more about this lung injury.
CDC developed guidance documents for were created to assist public health laboratories, healthcare providers, and pathologists, and others, with specimen collection, storage, and submission.
For more information and resources visit For the Public [cdc.gov], For Healthcare Providers [cdc.gov] and For State and Local Health Departments [cdc.gov].
Criminal Action Possible
In the case of THC vapes, FDA is conducting a parallel criminal investigation. In relatively rare cases, the enforcement arm of the FDA will conduct a parallel criminal probe to the public health investigation. FDA refers the case to the Department of Justice which investigate if the product wasintentionally and knowingly distributed adulterated product. In the case of THC vape products, the THC is an unapproved FDA drug for general non- prescription vape use (THC has been approved as prescription drug in Marinol), for which manufacturers could be liable. FDA and DOJ have made clear that they are not pursuing individual users but rather are investigating the supply chain, i.e. manufactures, distributors and retailers.
Long Term Impact
CDC declares an outbreak as over when people stop being sick and reports to CDC cease. CDC makes a public statement at that time. It takes time for the named product category to recover market share. Even if the source is traced to one particular company, consumers will avoid the category for a period of time. After the recent romaine lettuce foodborne illness outbreak, romaine lettuce lost market share for 6 months but is now back to normal sales levels.
If you are seeking advice on these matters, please contact Greenspoon Marder partner, Jessica Wasserman at 202-669-9449 or jessica [email protected]
