FDA Highlights Risks of Lung Illnesses Related to Vaping Products

The recent vaping crisis has drawn the attention of both the Food and Drug Administration (FDA) and the Centers for Disease Control (CDC). Although the effects are not fully known yet, the two agencies are rapidly investigating individual cases to try and determine the cause of recent lung conditions related to vaping.

While more research is still necessary to determine a possible link between vaping and respiratory illness, many patients have shown the following symptoms:

• Difficulty breathing
• Shortness of breath
• Chest pain
• Gastrointestinal distress (vomiting, diarrhea, fever, fatigue, etc.)
• Popcorn lung

The majority of individual cases are linked to THC use. As of now, both the FDA and CDC will continue to work with state health departments to gather additional information.

The FDA is actively analyzing and researching products and substances to find a cause for these illnesses, though no single substance is to blame yet. So far, the agency has analyzed 1,100 samples from 25 states, 908 of which were connected with consumers, hospitals, and state offices that have ties to patients experiencing vaping-related illness.

Is THC To Blame?

As mentioned, the FDA has not linked a single product to every case. However, THC use is widely prevalent among patients assessed. Out of 699 sample patients tested, 448 included THC. Additionally:

• 49% of these THC products contain the diluent vitamin E acetate, the concentration of which ranges from 23% to 88%.
• 24% of these THC products contain another diluent, such as medium-chain triglycerides.

The Facts and Figures So Far

• As of November 27, 2019, approximately 545 samples are directly linked to 74 patients, with CDC case numbers and samples from 70 of these patients having been analyzed.
• 79% of these 70 patients include links to THC products.
• 76% of these cases included products that had vitamin E acetate.
• 33% included products with aliphatic esters as a diluent (e.g., triglycerides).
• 5% included products with polyethylene glycol as a diluent.

Why Does This Matter to You?

If you are engaged in the manufacturing of vaping products, remember that process validation, analyzing adverse effects, and quality control should be a high priority. The FDA will be paying attention to these products, and your organization may require additional pharmaceutical training courses and certifications to stay compliant.

The recent vaping crisis has put vaping, THC, and other related products in the spotlight of the FDA. While no formal regulations have been issued as of yet, manufacturers should prepare themselves for new regulations as they are passed.

The recent vaping crisis highlights the importance of quality control and process validation. Please contact the Center for Professional Education and Innovation (CfPIE) if you are interested in updating your pharmaceutical training and certifications. Our team is available by phone at 1-610-648-7550 or by email at [email protected].