Sunday, September 6, 2015

Give the FDA A Piece of Your Mind

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The Food and Drug Administration (FDA) has extended the deadline to September 30, 2015 for its ongoing consultation with key players in the vaping industry, which include vape shop owners, e-juice manufacturers, online retailers, and the vaping community, in general.

Everyone can still submit their comments regarding the agency's agenda to regulate the vaping industry via two methods. One, you may visit regulations.gov and get involved in the rule-making process by following the instructions on how to submit your letters and documents electronically. Two, you may send hard copies of those documents via snail mail to the FDA's docket management office in Rockville, Maryland. The agency has provided the complete mailing address in the ANPRM memo that was circulated both online and offline in July 2015.

The urgency in which the FDA sought to acquire the power and authority to regulate the burgeoning e-cigarette industry was spurred on by alarming reports of accidental nicotine poisoning cases involving children (and sometimes pets). Foremost in the agency's agenda is the correct labeling of ingredients as well as the placement of nicotine exposure warnings on the lable and the standard use of child-proof packaging. Another objective of the FDA was to widely implement age-restriction laws that would curb underage vaping and prevent teens who didn't smoke from even starting a nicotine addiction with e-cigarettes.

It's also very likely that the agency would be limiting the public's accessibility to the raw materials that were used to create e-liquids to only licensed manufacturers. This would effectively stop all unregulated purchases of pure liquid nicotine (that's either extracted from tobacco leaves or synthesized in the laboratory) by private individuals who were mixing their own e-cigarette liquids.

The U.S. government hasn't discussed, at length, the proposed legislation that would redefine certain types of advanced personal vaporizers (APVs). Today, they're simply luxury items that people used for their vaping pleasure, but tomorrow, they could be the kind of gadgets widely recommended by doctors for nicotine replacement therapy (NRT). Public health officials and medical professionals would be able to recommend these APVs as therapeutic devices that could be used under medical supervision by patients who were undergoing tobacco harm reduction and smoking cessation treatments.

Collectively known as Electronic Nicotine Delivery Systems or ENDS in the future, these high-tech devices might also include microchip-controlled transdermal patches designed to deliver different kinds of drugs, such as miniscule amounts of nicotine, directly into a person's bloodstream through semi-automated epithelial injections set to occur at different times throughout each day.

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