Thursday, December 03, 2015

Once, Twice, Three Times a Liar: AAFP Letter to Congress on E-Cigarette Predicate Date Lies Three Times, Yet Still Fails to Make Its Point

In a letter sent yesterday to Representatives Paul Ryan, Kevin McCarthy, and Nancy Pelosi, the American Academy of Family Physicians (AAFP) opposes legislation that would change the predicate date for electronic cigarettes from February 15, 2007 to the effective date of the FDA deeming regulations.

According to the letter: "The TCA [Tobacco Control Act] requires that any new tobacco product introduced, or modified, after February 15, 2007, be reviewed by the FDA before it can be sold. HR 2058 would exempt from review all currently commercially available tobacco products that are not currently regulated by the FDA by changing the statutory “grandfather” date for tobacco products."

Unfortunately, in its attempt to persuade Congress to retain the 2007 predicate date, the AAFP lies to the House members ... not once, not twice, but three times.

The Rest of the Story

Lie #1: "The proposed bill would entirely undermine the FDA’s ability to review tobacco products, such as cigars and e-cigarettes."

The truth is that the bill would not undermine the FDA's ability to review electronic cigarette products. The FDA could still review any aspect of electronic cigarette products that it wished to. In fact, the FDA could promulgate safety standards that all products must follow, such as standards for battery safety, overcharge protection, restriction of certain dangerous flavorings (e.g., diacetyl), leak-proof cartridges, temperature regulation, and quality control. And the FDA could require all companies to document that they are in compliance with these standards, Thus, the FDA could directly review the safety of electronic cigarettes; in fact, in a way that is much more direct than what the AAFP is supporting. Using pre-market tobacco applications to review electronic cigarette products is not only a huge waste of time and resources, but it will result in undermining the public's health by allowing substandard and dangerous products, such as exploding batteries, to remain on the market for years. Direct promulgation of safety standards could take care of such issues in a matter of months.

Lie #2: "Were HR 2058 to pass ... the states would lose any ability to regulate or review tobacco products."

The truth is that the bill would not affect the ability of the states to regulate or review electronic cigarette products. The states are already going to be preempted from regulating aspects of electronic cigarette safety that are occupied by the FDA; however, this legislation does not in any way further tie the hands of the states. They are still free to take any legislative or regulatory actions that are not preempted by federal law.

Lie #3: "Because e-cigarette manufacturers are not yet required to undergo FDA review prior to introducing new products to the market, the FDA is not able to assess whether the thousands of flavors used in these products would likely contribute to the rise in youth e-cigarette use or present other health concerns."

The truth is that the FDA can still assess whether flavors used in e-cigarettes are appealing to youth or presenting other health concerns, even after these products are on the market. In fact, the FDA could set safety standards requiring companies to document basic aspects of flavoring safety. The FDA can also independently assess the safety and youth appeal of e-cigarette flavorings.

Despite this trio of lies, the letter still fails to make its intended point because it does not demonstrate how the public's health will be harmed by the passage of this bill. Every harm it claims will occur as a result from the bill is a lie. All that is left, then, is that the FDA would establish a huge bureaucracy that would take many years to review tens of thousands of product applications, while batteries continue to explode in consumers' faces. This is no way protects the public's health.

(See the op-ed by Scott Ballin and me published in The Hill for a more complete explanation of why the proposed legislation would greatly benefit the public's health.)

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