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April 11, 2011

Week 11 – Our 21st-Century Regulatory System

We continue to monitor the progress being made on President Obama’s “21st-Century Regulatory System” initiative intended to not only promote “economic growth, innovation, competitiveness, and job creation," but also to “root out regulations that are not worth the cost, or that are just plain dumb,” and yet at the same time “won't shy away from addressing obvious gaps.” 

This week we examine one small corner of what is perhaps the President’s signature attempt at streamlining federal regulations:

The 2000-plus pages of new federal regulations contained in the Patient Protection and Affordable Care Act of 2010, otherwise known as “Obamacare.”

Of course, those 2000 pages make up only a barebones outline, the actual regulations must be written by Executive Branch bureaucrats, those unsung heroes on whose shoulders rest the burden of determining whether or not vending machine labeling provisions apply to candy which can be picked up by maneuvering a large claw arm:

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Food Labeling; Calorie Labeling of Articles of Food in Vending Machines

C. Who Is Not Required to Comply With This Rule

Further, FDA tentatively concludes that vending machines that may dispense food as part of a game or other non-food related activity are not covered by 403(q)(5)(H) of the FD&C Act. For example, a vending machine may contain a variety of items ranging from small toys, coins, or individually wrapped candies that can be picked up by maneuvering a large claw arm. In this instance, the vending machine does not sell articles of food, even though in the course of maneuvering the arm, candies could be dispensed. The vending machine is selling the opportunity to play the game. FDA seeks comment on this tentative conclusion.

All we can say is thank goodness Congress reached a budget agreement, otherwise the highly paid professionals of the FDA wouldn’t be able to conduct their critical investigatory work into Congress’ original intent regarding arcade games.

Which brings us to perhaps the greatest constitutional crisis since the Kansas-Nebraska Act of 1854:

Does a “crank” fall within the penumbra of “button” and if so, what are the ramifications as it applies to bulk vending machines?

It’s a little long, but be sure to read the whole thing because only then can you truly see the world as they see it:

Bulk vending machines dispense unpackaged articles of food in preselected amounts (e.g. gumball machines, mixed nut machines). FDA received a few comments suggesting that bulk vending machines are different from ``more modern types of vending machines,'' and therefore should be exempt from these disclosure requirements. The comments argued that bulk vending machines should be distinguished from other vending machines for three reasons. First, they noted that these machines do not have selection buttons, and as a result a vending machine operator could not place a sign ``in close proximity to * * * the selection button'' that includes the calorie information required by section 403(a)(5)(H)(viii)(I) of the FD&C Act. Second, they argued that food sold from bulk vending machines represents only a small fraction of overall market sales of the vending machine industry.

Finally, the comments stated that there is no reported association between foods sold from bulk vending machines and obesity.

FDA notes that section 403(q)(5)(H)(viii) of the FD&C Act does not limit its applicability to vending machines for which there has been a reported association between the food vended by the machine and obesity. However, section 403(q)(5)(H)(viii) provides that for covered vending machine food, the vending machine operator must provide a sign disclosing the number of calories contained in the food ``in close proximity to each article of food or the selection button.'' FDA tentatively concludes that the reference to ``selection button'' in the statute can be read to mean that the types of vending machines subject to requirements in section 403(q)(5)(H)(viii) are those with selection buttons. FDA is not aware of vending machines without selection buttons other than bulk vending machines that dispense, by use of a crank, single types of unpackaged articles of food in preselected amounts (e.g., a single piece of gum or a handful of candy or nuts). FDA tentatively concludes that vending machines, including bulk vending machines, without any type of selection button are not covered by section 403(q)(5)(H)(viii). However, FDA tentatively concludes that a bulk vending machine that has a selection button, regardless of the type of food it dispenses, e.g., unpackaged articles of food such as soup, popcorn, or hot or cold beverages, is covered under section 403(q)(5)(H)(viii), if it meets the other statutory criteria. FDA is proposing in Sec.  101.8(c)(1)(i)(C) that the nutrition labeling requirements of Sec.  101.8 apply to an article of food sold from a vending machine that, among other things, has a selection button. FDA seeks comment on these tentative conclusions. FDA is also interested in comments demonstrating any unintended adverse effect resulting from the exclusion of vending machines without selection buttons from the calorie labeling requirements.

Some people seek greatness while others have greatness thrust upon them.  The men and women of the FDA probably never anticipated that they would find themselves suddenly enmeshed in this unforeseen dilemma but did they shrink from the challenge?  No! They embraced it putting forth their conclusions, tentative though they may be.

J.

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April 11, 2011 at 11:07 AM in Our 21st-Century Regulatory System | Permalink

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Comments

At first glance it seems like the "low hanging fruit" approach to political comedy to simply reproduce a huge chunk of FDA request-for-comments language and play it as satire, but somehow...it works.

Posted by: Michael | Apr 11, 2011 11:48:55 PM

Would it be possible to revisit the government shutdown event but make it selective?

Posted by: barryjo | Apr 12, 2011 9:37:54 AM

Barryjo,
are you under the impression that FDA-level efficiency is an exception in the federal government?

Posted by: Marty | Apr 12, 2011 10:43:18 PM

Marty,
Not at all. But we must start somewhere.

Posted by: barryjo | Apr 15, 2011 9:03:22 AM

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