To our customers, partners, and the public:
We would like to immediately clarify that the regulatory matter with the FDA, referenced in a recent Forbes article, was a civil case which has been fully settled and closed. This matter has been completely resolved and was not a cease-and-desist order.
This memorandum is also in response to the same article, the contents of which I found deeply concerning. Now that the FDA case is closed, I feel it is necessary to correct the record on several other key points from that article.
First, the claim that I, as CEO, made over $8.2 million is inaccurate. Since inventing the first anti-choking device over 15 years ago, Dechoker has yet to turn a true profit. In fact, I have often funded the company’s operations out of my own pocket, alongside the support of our investor partners.
Equally false is the assertion that anti-choking devices do more harm than good. These devices have saved hundreds of lives, particularly the lives of children.
While the FDA matter is now settled, it is important to understand the regulatory context behind it. The article correctly notes that we received a seizure warrant. This stemmed from a previous application we had pending for approval with the FDA. When an initial application for a new device that has never been on the market is turned down, it is immediately reclassified as a Class III device.
As a result of this reclassification, the device was considered “adulterated” under FDA regulations, and we were instructed to remove it from the market. We acknowledge that we did not move fast enough to pull the device from the US market, as this instruction coincided with several other events, including an FDA site audit.
It is also important to note that this scrutiny is not limited to Dechoker. As you might be aware, our competitor, the LifeVac, has also been pulled from the market. The FDA’s goal is to ensure that these devices are safe for the general public, and we support them 100% in this endeavor.
We deeply respect the authority of the FDA. They are the most comprehensive regulatory health agency in the world, and their approval is the toughest to get.
They have been very patient in working with Dechoker and continue to do so. They do a great job, are wonderful people, and we have enjoyed our time working with them over the past few years. When they tell you something, they mean it.
Following the settlement, we are now in the final stages of our new application, which has been submitted to the FDA. Having followed their instructions to the letter, we are confident that we will have the FDA’s approval in the near future. We are eagerly awaiting this approval to be allowed to sell in the US market again.
In the meantime, Dechoker continues to actively manufacture in Mexico and distribute its products globally. We hold approvals in other countries around the world and are actively selling and saving lives.
Nothing great ever came easy. This journey has been challenging, but it is a mission we will never abandon. These anti-choking devices are paramount for public safety. Hundreds of children are able to enjoy their lives today because of the successful intervention of the Dechoker. We will continue to work tirelessly and collaboratively with the FDA to ensure families everywhere have access to this life-saving technology.
We ask for your patience, and we ask you to stand with us in this essential cause. These must be made available globally in every store, pharmacy, nursing home, restaurant, first-aid kit and home in America, and in the world.
We appreciate Forbes for bringing this matter to the public's attention, and we will continue our mission with the full support of parents and children everywhere.
