(RxWiki News) The US Food and Drug Administration (FDA) has issued a warning letter to a company for selling illegal products.
These particular products are flavored nicotine gummies. The company under fire is VPR Brands, LP (doing business as, “Krave Nic”).
This is actually the first warning letter for this type of product according to the FDA.
The gummies being sold by VPR Brands, LP contain one milligram of nicotine. There are three flavors available for purchase:
- Blueraz
- Cherry Bomb
- Pineapple
The packaging indicates the gummies don't contain tobacco as they are labeled "tobacco-free nicotine."
The concern?
1. These gummies resemble candy or other types of kid-friendly food and in turn, have the potential to cause severe nicotine toxicity or even death among children. According to the FDA, research has shown if a child under 6 years of age (also depends on the child’s weight) consumes one to four milligrams of nicotine, it can be severely toxic.
Nicotine toxicity in children may lead to:
- nausea/vomiting
- stomach pain
- increased blood pressure and heart rate
- seizures
- breathing issues
- coma
- death
2. The FDA has never received a premarket tobacco product application from this company. Therefore, they are not authorized to make or sell these products in the U.S.
There has been an increase of non-tobacco nicotine in tobacco products (for example: e-cigarettes). As a result, Congress passed a federal law that went into effect on April of this year which states the FDA is authorized to regulate tobacco products containing nicotine from any source.
When digging a little deeper on the Krave Nic's website, it appears the gummies have been discontinued.
The company is expected to send the FDA a written response listing how they plan to address any violations as well how they will bring their products into compliance.
