Tuesday, April 24, 2012

Apple Gets an FDA Letter

April 23, 2012

Mr. Tim Cook
CEO, Apple Inc
1 Infinite Loop
Cupertino, CA 95014

Mr. Cook:

As I hope you are aware, under USC Title 15, Chapter 48, Section 2101, Congress has expanded the FDA's regulatory powers to cover all businesses that a consumer could reasonably (or unreasonably) believe are in some way involved in the production or distribution of ingested substances. Obviously, a company named Apple is now well within our purview. (And, if I may be frank with you, the use of a business name that creates the expectation of nutritional value when none is provided may, in and of itself, be the violation of several key regulations.)

However, it is my purpose today to provide a warning about Apple's current non-compliant marketing practices, hereafter to be referred to as NCMPs, and an order to cease and desist all such practices immediately. As these issues may be unfamiliar to a businessman who has not had previous dealings, I would encourage you to discuss the contents of this letter (subject to the counsel of your internal legal department) with executives from any pharmaceutical company, who are more than familiar with these regulations and how to comply with them.

Topic A: Promotion of product feature "Siri" included with Apple iPhone 4s

Our regulators have been deeply disturbed by numerous NCMPs associated with your introduction of "Siri". First, our scientific advisors challenge the often-repeated notion that this application represents "artificial intelligence" in any meaningful way. The literature on AI is well-established, and establishing that a device demonstrates it requires, at minimum, that it pass a Turing Test.  As there is no evidence Siri has done so, you are hereby not allowed to use this phrasing, or any similar phrasing, in promotional messages. Additionally, it is an NCMP to refer to Siri as a "personal assistant", as this implies human characteristics and abilities that it cannot possess. (You may use the word "assist" to describe the applications MOA.) To avoid any possible confusion, all television advertisements depicting human users easily and naturally interacting with Siri are deemed not compliant and must be removed from all media immediately. Finally, there is a lack of fair balance in your Siri-related communications. To avoid future NCMPs, you must include the rate at which Siri misinterprets commands given to it, and any possible safety risks associated with such errors.

Topic B: Promotion of "The New iPad"

First, we find the naming of the iPad problematic, and ask you to find a more suitable name within 90 days to avoid the product being withdrawn from the market and the levying of significant financial penalties. As you should realize, there is a high risk of confusion between the iPad and the iPod, which is a completely distinct product with a different indication. Without being too prescriptive, we would suggest that a name like "TouchTablet" would be more clear, and thus in the best interests of users. Additionally, it is a significant NCMP to use the neologism "Resolutionary" to promote the product. The obvious intent is to imply that this is a revolutionary product, when most experts believe that a sharper screen and better cameras represent, at best, an incremental improvement over previous models

Topic C: The Apple Store

An audit of your retail locations has unearthed a number of violations that must be addressed immediately. First, it seems you have been offering free setup of your products for some time, which is an obvious NCMP. Any incentive to purchase a product other than offering certain permitted discounts is a violation of regulations. Second, you are henceforth no longer permitted to call your technical support area a "Genius Bar" unless you can document that the average IQ of your support staff is over 135.

We find that these are the most severe regulatory violations, although we would strongly suggest you establish a registry to help investigators determine whether, as some initial studies indicate, your iPhone products are in fact addictive.

The attached 274 page form should help you get started in your reply to this letter. We look forward to working with you to clear up these violations, and ensure, for the good of the consumer, that your future marketing efforts are conducted in a more thoughtful and balanced way.


Dan Reed
High Inquisitor for Ridiculously Regulated Products

Editor's Note: I have fortunately never received an FDA letter myself, and I'm sure they're a bit more nuanced than my parody. But all of these theoretical violations on Apple's part do parallel the type of rules that pharmaceutical companies have to comply with when they want to talk about their products. So here's my question for my readers: do you think strictly limiting communications in this way actually helps consumers? Or, as I believe, do these rules actually makes it harder to communicate clearly about how health products can help people?

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