GEN-MKT-18-7897-A
Sep 26, 2019 | Blogs, Food / Beverage | 0 comments
The safety of vaping has recently become a topic of concern. The public wants answers about the safety of these products. Health authorities are scrambling to find the cause of the mysterious vaping illness that has been seen in hundreds of cases across the U.S., and that has caused multiple deaths.
Current news highlights related to recent cases:
Vaping has been around for years. It is too soon to know whether the recent cases are a new type of outbreak or something common that is just being seen through a lens of heightened awareness. The question remains: What is causing this illness?
Is investigating vitamin E acetate or polyethylene glycol the right focus? What about the questions surrounding the use of tetrahydrocannabinol (THC) as an ingredient in these e-cigarettes? Is mixing THC and nicotine to blame? The search for answers continues.
It makes sense to look at how an outbreak like this could happen. How could something unsafe make it into vaping products? One possible contributor to the situation is the lack of regulations around ingredients in both tobacco and cannabis vaping products. There is little transparency around ingredient labeling and few restrictions on additives. In an effort to further protect children, the FDA has announced plans to ban all non-tobacco e-cigarettes.
Another piece of the puzzle is the increase in counterfeit and illegal vaping products that have infected the market. Products are tampered with and adulterated, without consideration for the user’s safety. For instance, Wisconsin police reported a drug operation that was filling 3000-5000 illegal THC-infused vape cartridges a day for 2 years! Also, extremely concerning is that the THC potency of these products was 157 times higher than indicated on the labels. Imagine someone purchasing a vape pen from what they assume is a safe and reputable vendor (who follows strict testing protocols) only to find that it’s laced with synthetic cannabinoids, or worse, fentanyl.
Other states may soon follow Hawaii’s lead in regulating CBD products, now that the risk of vaping illness is very real. This might also impact CBD-infused drinks found on shelves in established institutions—due to a lack of testing to demonstrate product safety. It will be interesting to see how regulations evolve. Will the rest of the world follow India and ban e-cigarettes entirely, too?
As analytical scientists, we want to understand what about the vaping chemistry is causing injury. Is it a single toxic compound, or a mixture of substances? Is there a mechanism or trace-level compound that we’re not examining?
Stay tuned for part 2 of this piece where we discuss vaping chemistry and share what we found when we tested several commercial vape products.
As of the writing of this article, these were the most up to date facts and figures.
As an analytical strategy, middle-down mass spectrometry (MS) workflows characterize biotherapeutic proteins by analyzing large, digested protein fragments or defined subunits, rather than fully intact proteins (top-down) or digested peptides (bottom-up). A middle-down strategy combines the strengths of top-down and bottom-up approaches by delivering high sequence coverage and structural specificity while maintaining relatively simple sample preparation. In practice, middle-down analysis enables accurate mass measurement, rapid sequence confirmation, and localization of key post-translational modifications (PTMs) on protein subunits that are directly relevant to product quality.
In biopharmaceutical development, sequence variants (SV) are considered an inherent risk of producing complex proteins in living systems. Sequence variants are unintended changes to the amino acid sequence of a biotherapeutic and can be caused by errors in transcription or translation in the host cell, or cell culture and process conditions. Detailed analysis of SVs is important in process and product development to ensure the drug’s safety and efficacy. Even low‑level sequence variants can have significant implications for product quality, safety, and efficacy, making their accurate detection and characterization a critical requirement across development, process optimization, and regulatory submission.
CE‑SDS remains a cornerstone assay for characterizing fragmentation, aggregation, and product‑related impurities in therapeutic proteins. UV detection has been the long‑standing standard. However, it frequently struggles with baseline noise, limited sensitivity for minor fragments, and subjective integration.
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