Today’s Deadline for Seeking FDA Approval of Vaping Products Means Small Businesses Have To Pray for Bureaucratic Flexibility

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The industry’s fate depends on the whims of an agency charged with deciding what is “appropriate for public health.”

When the Food and Drug Administration (FDA) first outlined its plan to regulate vaping equipment and nicotine e-liquids as “tobacco products” in 2014, it estimated that it would receive 25 applications a year. Since the vaping industry includes thousands of manufacturers, ranging from big companies like Juul to mom-and-pop shops that mix the e-liquids they sell, the implication was that FDA regulation would wipe out almost all of them. Today the deadline for submitting applications, which has been moved repeatedly by the FDA and the courts, finally arrived, and the outlook for small businesses, though still daunting and highly uncertain, is not quite as dire as the agency initially suggested.

Under the Family Smoking Prevention and Tobacco Control Act of 2009, which the FDA is using to regulate nicotine vaping products, the entire industry officially exists only by the agency’s sufferance. The law required FDA approval of all tobacco products that were not marketed prior to February 15, 2007, before the vaping industry emerged in the United States. Once the FDA decided to treat nicotine vapes as tobacco products, it was only the agency’s enforcement discretion (combined with the practical difficulties of eliminating an industry with millions of customers) that allowed them to remain on the market. For companies that managed to meet today’s deadline, that sufferance will now be extended for a year as the FDA considers their applications.

Read full article here.

Jacob Sullum | Reason Magazine | September 9, 2020.

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