FDA Small Business Administration submits comment on FDA proposed rule

[aikanae1]

I was wondering how much teeth the SBA has as well. After looking at it, the SBA comments on many regulatory actions. Their points are valid and worth repeating, but it doesn't appear (imo) that they can "force" anything. I'm not that familiar with how this works.

Advocacy was established pursuant to Pub. L. 94-305 to represent the views of small entities before federal agencies and Congress. Advocacy is an independent office within SBA, so the views expressed by Advocacy do not necessarily reflect the views of the SBA or the Administration. The RFA, as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA),[4] gives small entities a voice in the rulemaking process. For all rules that are expected to have a significant economic impact on a substantial number of small entities, federal agencies are required by the RFA to assess the impact of the proposed rule on small business and to consider less burdensome alternatives.

 

[Jman8]

SBA puts FDA's (Proverbial) Queen: En Garde

 

[Kent C]

SBA puts FDA's (Proverbial) Queen: En Garde

It's more like they make sure the FDA pieces make the right moves. But they really can't stop them from checkmate.

 

[Jman8]

Only 2 ways I see the FDA gets put into checkmate.

1 - By Congress (seems unlikely to me, but putting them into check seems very possible)

2 - By FDA exercising harsh restrictions or banning. While opposite of check would be immediate experience of this for most people, it would be far more likely to result in checkmate than anything Congress can reasonably do.

Anyway, SBA has taken what I see as most key step to date for vapers, since 4/24/14.

 

[Kent C]

Only 2 ways I see the FDA gets put into checkmate.

1 - By Congress (seems unlikely to me, but putting them into check seems very possible)

2 - By FDA exercising harsh restrictions or banning. While opposite of check would be immediate experience of this for most people, it would be far more likely to result in checkmate than anything Congress can reasonably do.

Anyway, SBA has taken what I see as most key step to date for vapers, since 4/24/14.

For vendors perhaps, but that's their job. They don't really affect the game that much, imo. Either the Congress (perhaps under new leadership) or the Courts can affect FDA's game plan. And if it goes to the court, unless something comes down from the very top - such as a "hands off", then the SBA could be a player.

 

[Endor]

This is perfect timing. I'm just now getting to completing the CASAA 3rd call to action, and incorporated this into the boiler-plate comment section:

On the surface, the FDA’s proposed regulations are described in terms of protecting public health and safety. Upon closer investigation, they constitute a de facto ban of all e-cigarettes with the exception of low quality options currently mass produced by established tobacco companies. In fact, by the FDA’s own estimates, these regulations are expected to eliminate 99.9% of the products on the market because their manufacturers cannot afford the paperwork burden that would be imposed on them. The SBA Office of Advocacy recently published a comment to the FDA regarding the massive impact these regulations will have on small businesses that is not adequately represented in the proposed regulations (hxxp://www.sba.gov/advocacy/816/1086461]). Such a loss of variety, quality, and innovation would mean many people would be forced to consider returning to smoking and/or acquire products on a newly created black market.