Brick by Brick: the Challenge of Regulating

Overview of the regulatory process and the balance the FDA needs to strike.

Today I want to talk about the challenge of regulation, both in general and in the case of the FDA’s deeming proposal.

To start, where do regulations come from? The basic process:

  1. Congress passes a law, which is signed by the president. The law contains goals and general frameworks for regulation, but is something like a blueprint.
  2. The regulatory agency then takes that blueprint and tries to draft regulations based on it.
  3. The proposal bounces around inside the executive branch, to OMB and back to the agency, until a final proposal is ready.
  4. The proposal is announced (officially, via the Federal Register, and in media via press releases and press conferences).
  5. A period of comment is allowed for feedback on the various aspects of the proposal.
  6. The agency takes comments into consideration and refines the proposal into a final rule.
  7. The final rule bounces back and forth between OMB and the agency until ready.
  8. The final rule may be released, or another proposed version with another comment period may be used for further refinements.
  9. Once the agency begins enforcement actions, the affected parties may bring suits under a variety of causes, challenging the regulations.

The actual process is a little messier than the above, but that’s the basic framework. We are at step five in the process.

Now, the statute is law. Regulations have the force of law, but they are inferior to statute. So when people complain about an agency’s regulations, they may be off-base. Often, the statute, and by extension the congress, bears more blame for bad regulations than the agency.

Agencies can interpret statutes incorrectly (sometimes by mistake, other times due to vague or inconsistent statutory language). And they can overreach. But most agencies under most administrations try to follow the law, including the vague goals set in law by Congress.

Now to the proposal. The FSPTCA was designed for regular tobacco products, particularly cigarettes. Several years ago FDA took enforcement actions against ecigs as drug delivery devices. Why? Because under their interpretation of the law, they thought that action fit, and they enforce the law.

The judge in Sottera said that it did not fit, and suggested that FDA might regulate under the then-newly-passed FSPTCA. So FDA is going forward under the assumption that FSPTCA gives them authority, even if the law wasn’t written or intended to regulate ecigs. Keep in mind the FDA is still coming to terms with operating under the FSPTCA, as their regulatory history is of very different cloth.

When regulating drugs, FDA has a clear partner and adversary in the pharmaceutical industry. They have a clear mandate and a long history of how drugs get approved, and their employment and measures reflect a particular understanding of their duty. The culture for tobacco products at FDA is still nascent.

As they attempt to regulate ecigs, or even traditional tobacco, there are sure signs of the opposing forces of their drug regulation culture and the statutory requirements for tobacco products. They aren’t used to dealing with an industry without doctors, for example. Drugs mostly go through doctors and pharmacists.

They aren’t used to consumer products, as drugs and medical devices don’t tweet every time you use them (okay, so no ecig does that yet). And medical products tend to be expensive, so FDA isn’t used to products that need to retain reasonable prices.

The regulatory schema for food under FDA is very different. It’s mostly a matter of safety. Keep out cancer-causing substances, for example. And some of the authority over food sits with the USDA, which means FDA only partially controls the landscape.

FDA wants to strike the right balance, while upholding the law. That’s their job. But as consumers our chance to tell the FDA what that balance should be is the comment period. By submitting good comments, we can help the FDA understand the proper model for regulation here, and in doing so help them develop the right culture for all tobacco regulation going forward.


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