As an indication of how slow the rule making process can be – due to the volume of public comments filed with the FDA – five weeks after the deadline, all the comments are still not available on the FDA’s website. As everyone is aware, there are two separate proposed rules pending, and apparently thousands of comments were filed on each.
The next step in the process is for the FDA to make all the comments available to the public and any interested parties. This will occur after the FDA screens the comments to make sure they are applicable to the rule the FDA is proposing. This is an important part of the process for us, as well, because this will be our first opportunity to see what the “other side” is encouraging the FDA to do.
For example, in our comments on the restricted device rule banning under-18 tanning, we argued strenuously that the proposed rule is contrary to law because that restriction does not meet the statutory criteria articulated in § 520(e) of the Federal Drug and Cosmetic Act. We pointed out in 2015, when the FDA reclassified sunbeds to class II devices, that they added a “special control” by requiring an additional warning that the product should not be used by someone under age 18. That only went into effect last October, and we maintain that the Agency did not allowed an adequate period of time for the effectiveness of that special control to be evaluated before deciding that it was ineffective or that it didn’t go far enough.
Our legal team also thinks the FDA’s decision to attempt to ban teen tanning is unconstitutional. In our comments, we pointed out that the U.S. courts have always protected the fundamental right of parents to make decisions concerning the care, custody and control of their children, and this proposed restriction runs counter to that right. Also in our comments, we offered a compromise position requesting that the FDA include a parental waiver or parental consent option.
Although many states have already passed laws restricting teen access, it is still important that we take a strong stand on this issue. Our detractors will almost certainly press for further age restrictions. We have to make it clear that this is important to the industry, and we have solid legal backing to oppose it. Only after we finally have access to all the comments will we fully understand what the other side is advocating.
These points are some of many points we made in our comments. If you have not had an opportunity to read what the ITA and ASA jointly submitted on both the proposed rules, I encourage you to go to the ITA’s website (theita.com) and look under the “Government Relations” tab and read these documents. Although together they are over 300 pages, each submission has a good executive summary which outlines the major arguments. I think you will be impressed.
I encourage you to join the ITA, and join us in our fight to protect YOUR industry.
