Fully Loaded Chew Files PMTA Application with FDA
A little-known provision in a recently passed government budget allows the Food and Drug Administration to regulate nicotine from any source, including synthetic nicotine. The bill, passed on March 11, 2022, gave Fully Loaded a very short window to file for permission to continue to sell our products to the public.
Let’s be clear, Fully Loaded is 100% TOBACCO FREE. Even our nicotine is the purest form of lab-derived nicotine available. Unlike other tobacco “alternatives,” Fully Loaded does not use Tobacco Derived Nicotine (TDN), thus does not contain several of the top carcinogens found in tobacco or TDN.
While the timeline provided by the FDA was extremely short – only 30 days – the Fully Loaded team worked around the clock to submit all applications by May 14, 2022.
This was a monumental task for such a short amount of time. Other brands have chosen to either ignore the mandate, and sell illegally, or to simply close shop and walk away.
Unfortunately, we did have to make the tough decision to remove a few of our products from the lineup. There simply wasn’t enough time or resources to be able to submit comprehensive studies for every single nicotine product we sell.
Fully Loaded was started by people just like our customers – hard-working, passionate fighters. Just like them, we don't give up.
While we have submitted the applications, this isn't the end of this process, not by a long shot. Filing the application was the first step and now our fate rests in the hands of the FDA to evaluate our product, look at the science, and review the THOUSANDS of letters of support and reviews our dippers have shared with us. They are truly in this with us, and we couldn't keep up this fight without them. But now, WE WAIT.
Most importantly, our extensive independent lab testing allowed us to compare our products to some of the top tobacco brands on the market. We've included a few charts below to show the hard science behind why Fully Loaded is the right choice as a tobacco alternative.
Please look at the data below. It will show how Fully Loaded contains ZERO chemicals widely recognized as the top cancer-causing agents in other tobacco products called NNN and NNK. Please keep in mind that many other tobacco alternatives use Tobacco Derived Nicotine that still contain these cancer-causing agents! Consumers deserve to know the truth. They deserve to know what they are putting in your body. And they deserve to LIVE FULLY LOADED!
Table 1. Demonstrates how Fully Loaded contains ZERO trace of NNN - a known carcinogen in Tobacco and Tobacco Alternatives using TFN.
Table 2. Demonstrates how Fully Loaded contains ZERO trace of NNK - a known carcinogen in Tobacco and Tobacco Alternatives using TFN.
Table 3. Demonstrates how Fully Loaded compares to Copenhagen Long Cut for various chemical compounds found in tobacco