In late June, the ITA/ASA teams met with officials at the FDA to provide the Agency with additional information relative to the final disposition of the two pending proposed rules. Everyone who attended the meeting from our camp agreed that it was very worthwhile. The FDA representatives were engaged, asked good questions and seemed to appreciate the information we provided.
As we have previously discussed, the FDA has been working off tanning industry data that is at least five years old. When issuing proposed regulations, an agency is required to take into consideration the impact a new rule will have on the affected businesses. We wanted to make certain the regulators understood that the indoor tanning industry is much smaller than it was when the economic impact study was completed. We presented up-to-date information regarding the numbers of equipment manufacturers, lamp manufacturers, product distributors and salon facilities currently conducting business in the U.S. market.
Our goal was to make sure the Agency has all the facts required to issue a workable final rule. It is my experience that regulators don’t always understand the impact of the rules they issue and enforce. In discussing the current state of the industry, we wanted officials with whom we met to appreciate that tanning industry data is more than numbers; it’s real people working hard every day to make a living and provide for themselves and their families.
We asked the Agency to fully consider the economic impact that any new regulations will have on the indoor tanning industry and the thousands of small businesses that comprise it.
We also discussed in detail the history of the FDA’s regulation of our industry. In 1985, when the Agency issued the performance standard under which we currently operate, they stipulated that the regulations would only apply to sunlamp products manufactured after that date (in 1985). We asked the Agency to follow that precedent and when it finalizes the proposed rule, to grandfather the sunlamp products currently in the marketplace once again.
We are optimistic the FDA understands our concerns.
