Last week, the FDA sent a warning letter to Procter & Gamble, presumably the same one that was posted a few weeks before by the agency, and then retracted. Well, it is either back, or we are all experiencing a profound sense of Déjà vu. In fact, the FDA's press release states that they are the same ones that were mistakenly posted on October 14 due to computer error. (Really, the computer did it?)
The targeted products were Vick's Dayquil and Nyquil both with vitamin C added. The reason? According to the release the reasoning was:
- To clarify that these single dosage form combinations of drug ingredients and dietary ingredients legally cannot be marketed because they have not been proven safe and effective, and
- Because the agency previously determined that there are insufficient data to show that vitamin C is safe and effective in preventing or treating the common cold.
While technically accurate, it does seem odd when you stop to think that a HUGE percentage of people who get a cold start beefing up their Vitamin C. So why not offer a product that does it for you and relieve the consumer of a little pill burden. Well, the reason is that the FDA has said Vitamin C is not effective and expressed that in several Warning Letters previously.
It is one of those cases, of which there are a growing number (like the action against paid search), where regulatory action is taken to keep a company from doing something that does not comport with the true reality of consumer uses. Still, the FDA does have to protect the integrity of the process and, where it has said Vitamin C is not effective, stick to the story.
And the vehicle of a Warning Letter was probably based on the fact that the release states that the agency has enunciated this principle in prior Warning Letters. Though they are not cited in the release, they are cited in the Warning Letter to P&G. Some of these were recent and some went back to 2001.
A few thoughts on this. Warning Letters are reserved for issues that involve matters of true public health concern. This obviously does not qualify in that regard since most consumers are popping Vitamin C during a cold as frequently as aspirin. But they are also issued when there is an issue that has been around for a long time and people don't seem to be getting the point.
So the takeaway lesson here is that it pays to examine and analyze Warning Letters as they come take away key findings that companies use to integrate in their own planning and to use to re-evaluate its own activities and product marketing for risk exposure. That is one of the many reasons, Eye on FDA supplies you with quarterly overviews of Warning Letters. Speaking of which, we are due for one later this week.