The BeActive® brace is a leg wrap that reduces tension on the sciatic nerve, thereby reducing lower back pain. It is sold through television advertising, a website, a distributor, and most “big-box” retail channels. It is a huge success, with more than 3 million braces sold.
FDA Flip Flops: What Kind of Medical Device Is It?
Although the brace is not marketed as a medical product intended to cure any disease, it is nonetheless a Food and Drug Administration (FDA)-regulated “device” because it is “intended to affect the structure or any function of the body of man.” Unless specifically exempted, all new devices must receive premarket clearance from the FDA. The FDA requires a very expensive and time-consuming “premarket approval” for all new medical devices, unless the marketer can demonstrate that the new device is “substantially equivalent” to a pre-existing, legally marketed device by filing a Premarket Notification (510(k)).
Initially, the FDA headquarters — specifically, the Center for Devices and Radiological Health (CDRH) — determined that the BeActive® Brace was a 510(k)-exempt device. Yet, in fall 2014, an FDA district office began detaining imported shipments of the braces for lack of a 510(k). Headquarters then reversed its position, supporting the district office’s detentions, leaving product marketer Top Dog Direct’s shipments and the future of its business in jeopardy.
How Would You Get a Shipment Released by the FDA?
The executive team at Top Dog Direct and its affiliated companies, Plymouth Direct and Natures’ Pillows, turned to trusted advisors FDAImports.com and Benjamin L. England & Associates to tap into their decades of FDA regulatory and legal experience to craft and execute a way through the FDA. In the first few weeks, FDAImports.com was able to get around a dozen shipments released using legal advocacy, procedural techniques, and their extensive relationships at the FDA — but then the FDA locked down again.
BeActive® attempted to pacify the FDA by proposing new advertising wording and new labeling claims on the box. Since all advertising in traditional media and on the internet can be considered part of a product’s “intended use,” this represents a significant undertaking. FDAImports.com and BeActive® even offered to proceed with a 510(k) filing, even though they believed it wasn’t necessary, if the FDA would go back to allowing their shipments to proceed to market. The FDA failed to respond to the company’s offers.
With inventories rapidly disappearing, the company knew it was in trouble if it could not get braces onto store shelves and in distribution soon. The relationships the company developed with mass merchants would have been seriously damaged and its investment in advertising would have gone down the drain. According to Bill McAlister of Top Dog Direct, “BeActive® would have gone out of business, plain and simple.”
You Know, You Can Sue the FDA
FDAImports.com and Benjamin L. England & Associates, LLC suggested a strong course of action: sue the FDA. As Steve Silbiger of Plymouth Direct recalls, “We felt there were no alternatives to suing the agency. For the FDA, time was not of the essence — but it was for us.”
So, on a Monday, the companies filed a motion for temporary restraining order (TRO) in a United States District Court to halt the FDA’s detention of shipments. Within three days, and without trial, the FDA caved. An agreement was reached, whereby the FDA would allow shipments to be imported and distributed, and BeActive® would proceed with the 510(k) clearance process. The results: contracts fulfilled, relationships maintained, and product moving into the hands of consumers.
Today, the BeActive® team is excited to have its brace 510(k) FDA-cleared — and with stronger marketing claims! The marketers are looking forward to sharing additional product benefits in a new campaign soon.
FDAImports.com Is Like a Partner
Recently Steve Silbiger reflected on the support the marketers received from FDAImports.com. “They didn’t just know the procedures at FDA, but understood how the place works,” he said. With 120 years of in-house FDA experience on its team, FDAImports.com’s regulatory specialists and affiliated attorneys get to the heart of claims issues with the FDA and the Federal Trade Commission (FTC).
“FDAImports.com gave us great advice and has been our partner,” said Bill McAlister. “They can navigate through any FDA issues that come up.”
Companies with medical devices, cosmetics, over-the-counter drugs, homeopathic remedies, dietary supplements, functional foods, and other FDA-regulated products turn to FDAImports.com and Benjamin L. England & Associates for new product, manufacturing, importing, advertising and marketing issues.