Legal Defense for AniCell Biotech

You might have seen or heard that the United States Department of Justice, on behalf of the FDA, has recently filed a complaint against AniCell Biotech LLC.

In 2015, AniCell Biotech pioneered and created a novel, amnion tissue allograft to be used regeneratively for animals. Quite simply, we are in the recycling business, collecting non-invasively what God created all living things from and utilizing it as a physical bio-scaffold to address wounds in companion animals, delivered by licensed veterinarians. Tissue-based products like demineralized bone matrix and porcine bladder products in animal health are characterized as medical devices since the inception of the FDA CVM and currently there is no regulatory language to the contrary.

After we founded the company, the FDA CVM published guidance (not regulation) seeking to categorize all tissue-based products as drugs, even though the 21st Century Cures Act (signed into law on December 13, 2016) on the human side, established a significantly less onerous and separate pathway for tissue-based regenerative products.

After seven years in business, 20,000+ treatments with a 94% efficacy rate and zero severe adverse events recorded, AniCell and myself, as CEO and Founder, have been served with a complaint from the US DOJ seeking a permanent injunction from marketing or selling these products based on some of the language on our previous website and their errant claims that we have never responded, never filed an application for an Investigative New Animal Drug (INAD)and never tried to resolve this issue.

To the contrary, AniCell has had several proactive conversations with the FDA regarding the allegations that our regenerative products are drugs, primarily based on how we initially referred to them on the old website. We corrected our website in 2017 to address any FDA language concerns and then led the way in science to show how these products work as a physical bio-scaffold to achieve the primary intended purpose of wound care. Our regulatory attorneys have repeatedly requested meetings to discuss these issues and have been denied every time. We filed an INAD (INAD file number I-013594) on December 3, 2021, in an attempt to address any lingering concerns. While we, and our legal team have reached out several times to provide data and interact on ony outstanding issues, , interaction was denied.

On the other hand, AniCell has successfully worked with the United States Department of Agriculture (USDA)for several years. Based on the Virus-Serum-Toxin Act of 1913, the USDA has oversight over veterinary biologics. Multiple issues have plagued animal health and at the USDA’s behest, AniCell has achieved positive impact by being deployed at the request of state agencies to lessen the impact of quarantine periods.

Quite simply, this is egregious government overreach, and it will impact all aspects of animal health going forward. We did not skirt government oversight, as evidenced by our three welcomed FDA inspections of our lab which are now referenced in prosecuting us. It is also interesting to note, no other regenerative products or companies are being subjected to this scrutiny; we have been made a target.

What does this mean for you? There is no immediate cease and desist and I believe we are several months from going to trial. So for us it is going to be business as usual.

If you would like to help, please pass this on to your local congressional representatives in DC. This egregious governmental targeting cannot stand and we look forward to our day in court.

We have set up the AniCell Legal Defense Fund on Go Fund Me to help fight this complaint. Please feel free to forward to your customers and others that are against government overreach and targeting.

On behalf of industry and our technology and the animals we love, we will fight this. We are immensely grateful for the help of our team, customers, other industry members, association partnerships and our local members of Congress. We do not know where this targeting originates but believe “because we said so” should be left to our parents, not the federal government.