FDA Detains Back Pain “Relief” Braces

The FDA is detaining foreign shipments of leg braces claiming to relieve back pain until the importers and distributors can prove that the braces are compliant with the classification requirements of the 510(k) clearance program.

The importers and distributors, Plymouth Direct Inc. and Nature’s Pillows Inc., filed suit in federal court on November 3, 2014, saying that the agency initially told them that the device did not require clearance and considered the device, the BeActive leg brace, a Class 1 product. Class 1 devices are exempt from 510(k) clearance requirements.

On April 24, 2014, the FDA’s Sylvia Gaytan emailed the company and said:

Thank you for your patience while waiting for our response on the subject. CDRH [Center for Devices and Radiological Health] has determined that the brace as described below would fall under 21 CFR 890.3475 as Class I, 510(k) exempt. However, your firm will have to register and list the product and comply with the general requirements for record and complaint files.

The FDA then noticed that the labeling on the device packaging suggested that it relieves pregnancy-related back pain. That claim, says the agency, would require obtaining 510(k) clearance.

The agency then detained the braces which are manufactured in China, through its “detention without physical examination” (DWPE) authority under the Federal Food, Drug and Cosmetic Act (FD&C).

According to a November 11, 2014 MED Device Online article by Nick Otto, the companies argue that the agency’s decision to detain the braces is “arbitrary and capricious, ” and that the agency hasn’t “articulated any rationale” in supporting the conclusion that the initial determination to categorize the devices as a Class 1 device as incorrect. This has shades of the recent appeals court ruling that the agency lacked authority to withdraw 510(k) clearance without proof of wrongdoing. In this case the companies are assumed to be guilty until they can prove their innocence.

Otto writes that according to Registrar Corp, “Products subject to DWPE will be detained at the U.S. border without being examined by FDA. The importer or exporter of the product must then prove to FDA that the shipment is compliant in order for the product to be released into the United States.”

According to the FDA, a DWPE will be recommended if there is evidence that shipments from an importer don’t follow legal regulation. Some examples the agency provides include:

• There is information received from other government agencies concerning violative practices by the importer or the importer’s foreign suppliers that would cause the articles to appear violative.
• There is a documented history of attempted importation of violative articles that has resulted in the issuance of a warning letter to the importer with no subsequent response from such importer or which does not result in the correction of such practice.
• There is verifiable information in the form of consumer or trade complaints, or otherwise, that has the effect of causing the articles offered for import to appear adulterated, misbranded, or otherwise in violation of the FD&C Act.

The beactivebrace.com website makes the following claims:

REVOLUTIONARY DISCOVERY:

• The patented pressure pad in the brace applies targeted pressure to the specific point that provides back pain relief
• Reduces back pain
• Quick and easy to apply
• Works on either left or right leg
• Discreet and easily hidden under your clothing
• Holds firm and comfortably while exercising or at work

Oh, and buy one and get on free for just $19.99.

Sales and Customer Satisfaction Claims

In its lawsuit, Nature’s Pillow claims it sold more than 600, 000 units worth $4.7 million in the U.S. from August 2014 through October 2014. Overall, more than 2.2 million units have been ordered by U.S. customers. The company tells the court that customer satisfaction is “exceptionally high, ” having a return rate of only 0.51%, “well below” the industry standard.