Posts Tagged ‘faux flugelhorn’

TubularArtCarOne of the things I tell students is that you can learn a lot about document requirements by back-engineering from failed documents or from situations where people run afoul of the law [or simply common sense: those endless “stupid” instructions about not taking a bath with your curling iron clearly indicate that some fool out there did exactly that, with Darwin-award-winnng results].

So, if you look at the FDA Enforcement summaries for 2008, you can learn a lot about what ridiculous things people try, and what you would need to do differently in order to land on the right side of the law. One outrageous example is as follows:

Internet Selling of Illicit Street Drug
On January 31, 2008, the FDA sent a Warning Letter to Ms. Jennifer Gulla of Laguna Niguel, California, for marketing the product “Blow” on her Website. “Blow” is marketed as an alternative to an illicit street drug and is intended to affect the structure or function of the body. “Blow” is well known street drug terminology for illicit cocaine, and the term may suggest that the product has effects on the body similar to cocaine.

The FDA had become aware of the proliferation of various products that were being manufactured, marketed, or distributed as alternatives to illicit street drugs. FDA is concerned that these products pose a potential threat to the public health. Some street drug alternatives are being marketed as dietary supplements. FDA does not believe that street drug alternatives are intended to be used to augment the diet, to promote health, or to reduce the risk of disease.

Accordingly, street drug alternatives do not qualify as dietary supplements. In March of 2000, FDA made available guidance for industry on street drug alternatives. This document contains additional information and is available at:

FDA considers “Blow” a drug because it was intended to affect the structure or function of the body of man or other animals. Moreover, this product is a new drug because it was not generally recognized as safe and effective for its labeled uses. The sale of “Blow” without an approved application violates the law.

To view the full text of the Warning Letters:  http://www.fda.gov/foi/warning_letters/s6674c.htm

Source: FDA Enforcement Story for 2008, Chapter 3, pages 17-18

Now, as you may have noticed, we have a bonus hairpin turn in this example: the FDA says that faux street drugs cannot be sold as “dietary supplements”, but since they are being sold as something to affect the function of the human body, they are “drugs”, and therefore must undergo years of testing to demonstrate that they are

  1. A consistent chemical formulation
  2. Formulated in a safe, clean manufacturing environment
  3. Safe for humans to use in established doses
  4. Effective at doing what they claim to do

And, of course, if they _are_ effective, they will be banned as purposless intoxicants anyway, unless you happen to be a celebrity or anyone with more money than sense.  Whee!

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