The U.S. Food & Drug Administration (FDA) is at it again with more proposed regulations that are likely to affect salon owners in a big way.
The Indoor Tanning Association recently became aware of the FDA’s attempts to regulate the indoor tanning industry yet again. While neither the ITA nor anyone else outside of the government knows the details of the FDA’s proposal, members of the ITA believe the Federal organization will seek a national under-18 tanning ban as well regulations that allow the FDA to oversee the way salons advertise to their customers. Because of this, the ITA is gearing up for what is sure to be another major battle at the Federal level.
Members of the ITA were made aware of these latest developments by closely monitoring all activities of the FDA, says John Overstreet, ITA Executive Director. He explained, “Before an agency such as the FDA can propose new regulations, those proposed regulations must be cleared by the Office of Management and Budget (OMB) regarding how they might affect jobs and the economy.” When the FDA submitted the proposed rule to the OMB it was logged onto the OMB’s website, which is how Overstreet and the ITA Board became aware of the threat.
“Unfortunately, we still don’t know the details of the proposal,” Overstreet said.
Given Overstreet’s political experience, he believes he knows what to expect from this issue. “The FDA is asking OMB to sign off on making all sunlamp products “restricted medical devices,” a designation that would give the FDA a great deal more scrutiny over our entire industry,” he said. “With this designation, the FDA could also put restrictions on sale or distribution of tanning devices, such as requiring a prescription and/or specific training to operate a salon.” With the restricted device designation, the FDA will have the authority to oversee salon-to-consumer advertising. “Right now, the FDA only has authority over manufacturer- and distributor-to-salon advertising,” he added.
Now that the FDA has proposed this rule, the OMB can approve, reject or direct the FDA to do additional work on the proposal and/or make changes. Given the regulatory attitude of the current administration, Overstreet believes the possibility of the OMB rejecting the proposal is highly unlikely. However, it does not appear that the FDA has done its homework regarding the potential impact of this designation. He added, “Our next step is to find out the details of the proposal, which we are working on. We plan to then enlist the support of the Small Business Administration to help us show the OMB that this proposal, coupled with the recent reclassification, and the possibility of amendments to the performance standard (21 CFR 1040.20), will have a severe negative impact on tens of thousands of tanning salons.”
The ITA plans to call upon the political leaders with whom the organization has developed close relationships over the years to brief them and gain their support in this effort. Overstreet added that he expects the ITA to schedule a meeting with the OMB to make its case as soon as possible. “This is a multi-step process that could stretch out over many months but because of the potential negative impact this proposed rule could have on our industry; it is a matter of the highest priority for the Association.”
The FDA’s recent proposal comes on the heels of its decision to reclassify tanning units and sunlamps as Class II medical devices, which became law earlier this year. The ruling requires tanning system manufacturers to prominently feature revised warning labels on their products as well as to supply brochures informing people – mostly those under 18 – that multiple use increases the risk of cancer. The ITA and other industry experts did not consider the ruling to be excessive governmental interference, especially when compared to the Federal Tan Tax and several under-18 tanning bans.
As the ITA heads into what might well be another Federal battle to defend salon owners’ right to do business, there are two things you can do to help. The first, all-too-crucial step is to join the ITA, and reaching out to state and Federal lawmakers is the second way to help. By getting to know their lawmakers on a first-name basis, salon owners can form relationships that are very helpful both now and in the future.
The ITA is the only organization looking out for salon owners’ interests, so the organization deserves your support! To join, contact the ITA today at 703.336.3632, email admin@theita.com or visit theita.com. ■
Executive Director’s Report
The Industry’s New Challenges from the FDA
Accompanying this report is an article by John Ribner that explores in greater detail how we learned in October that if the FDA has its way, all sunlamp products, sunbeds and sunlamps will become “restricted” medical devices.
On a scale of 1-10, with 10 being as bad as it gets, this may be an 8 or it may be an 11 … we won’t know until we see the FDA’s proposal in writing. Until then, we can surmise with a high degree of reliability that we won’t like what they are proposing.
We also learned in October that the FDA is in the final stages of drafting amendments to the performance standard (21 CFR 1040.20). Depending on the details, this too could have a significant impact on how all of you run your businesses.
If there is any good news, even bad government often moves at a snail’s pace and we think we will have a number of months and possibly even a year to plan our defense and build a war chest to fight this. Unfortunately, this will be a very expensive fight.
Because of the cutbacks the Board has made over the past 18 months, the ITA will enter 2015 on the best financial footing we have had in 3-4 years. But the revenue targets we established in 2014 carried over to 2015 may not provide us with the resources we will need to address these challenges next year.
For too long, too many have remained on the sidelines and let others worry about these issues. If we are all to succeed, this has to change. Right now, the overwhelming majority of ITA members are manufacturers and distributors. They have carried the financial load for this organization for the past three years. It is time for others to step up.
At the Board meeting in September, dues for salon members were lowered to $200/location per year. If only 30% of salon businesses in the U.S. supported this effort, we could raise $1,000,000 and ensure that we have the best legal team and lobbyists in the city working on your behalf.
Join our team now! Visit theita.com and become a member. If you wait for someone else to fight this battle, ultimately there may be no more battles left to fight. ■
Thanks,
John Overstreet
