FDA New Regulation to Penalize Freedom of Speech About Vaping Products and Consumer Opinion

“To CRA or not to CRA?  

CRA you say?  What the heck is that?  The Congressional Review Act is a law enacted in 1996, which basically creates an opportunity for Congress to negate or invalidate a regulation put forth by an executive branch agency.  Do I have your attention now?

The Congressional Review Act (CRA) states that before a rule can take effect, an agency must submit the rule to Congress with a statement on its impact and whether it is a major rule.  Upon receipt of this report, Congress will have 60 legislative days in which to take action on a joint resolution of disapproval of the rule.  If the joint resolution of disapproval is submitted within the CRA specified deadline, and signed by the president, the “rule shall not take effect (or continue).”  Such rule would be deemed not to have any effect at any time – even provisions that had become effective would be retroactively negated.

What’s more, if enacted with regard to a rule, the CRA prohibits that agency from issuing any rule that is substantially the same in the future, and prohibits judicial review of this action!

I know what you are thinking…. THE FDA DEEMING RULE!  Unfortunately, the 60 legislative day limit – looking back 60 days in which Congress was in session and doing legislative business – only takes us back to early July. And, the FDA final deeming rule was submitted to Congress in May. Basically, the deeming rule was too long ago to exercise CRA option on it. So, we will have to use other tools at our disposal to address the deeming rule – including changing the predicate date and working with the new administration, etc.

However, there is another very important rule to which Congress could – and should – apply the CRA process.  I refer to the rule made final earlier this month by FDA, which I call the “Intended Use” rule.

The Intended Use rule is nefarious because it is how FDA will extend its prohibition on free speech and possibly hold manufacturers accountable for what OTHERS say about their products. That is, they prohibit you and anyone who sells vapor products from making truthful statements about relative risks of vapor products and smoking. This rule prohibits you from even citing peer reviewed scientific studies such as the Royal College of Physicians or Public Health England studies in conjunction with your business. Click here to read the rule.

Not only does this rule prohibit manufacturers and retailers from making certain truthful statements regarding risk, smoking cessation, and health issues, but it goes even further. The FDA is giving itself the authority to use not only statements made by you to determine whether prohibited health claims are being made, it also says FDA may consider other evidence of intended use, which may include “circumstantial evidence.”

FDA could use this as justification to force products off the market as unapproved medicine, medical devices, or combination products. Remember, this is the same justification the FDA used to seize vapor products several years ago before the federal court system told them (Sottera v. FDA) that they could not do this because the manufacturers who sued the FDA were not making health claims in marketing e-cigarettes.

This new restriction and enforcement power really bothers me. Because, once freedom of speech is so severely restricted, open debate about our products and public health can be critically harmed. Truthful statements should be allowed and their veracity can be tested through other mechanisms.

If this rule remains in effect, we will not only be keeping life-saving facts from the public.  We will also be left fighting this battle without being able to state facts to public audiences whose opinions sway the will of elected officials. 

In any case, NO governmental organization should be permitted to use “circumstantial evidence” (presumably what consumers are saying about cessation online??) to stop a product from being sold.

How are we, as a society, going to have an honest and open discussion of tobacco harm reduction if one side is prohibited from educating customers and the public while the other is constantly pumping out ridiculous propaganda?

Congress should consider submitting a resolution of disapproval on this new FDA “intended use” rule. If you agree, please call or email your Congressmen and urge them to apply the CRA to this rule promptly, before it does irreversible damage.”


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