What Difference Does FDA Market Authorization For a Tobacco Alternative Make?

Since its beginnings, the tobacco industry has been notorious for its efforts at deceiving regulatory establishments as well as consumers. From vintage ads targeting women who wanted to lose weight and promising that smoking would help your cough, to more recent efforts discrediting the idea that smoking has a direct correlation with lung cancer, and that nicotine is addictive, tobacco companies have shown that the bottom line is more important than consumer well-being.

The FDA currently has jurisdiction over all tobacco products as well as “deemed” tobacco products like e-cigarettes, hookahs, and tobacco alternatives. However, if a product manages to slip through the cracks and remain on the market despite lack of compliance with FDA guidelines (there are over 400 million products currently listed and required to submit paperwork, so enforcement is a challenge), there is little in the way of it’s manufacturer making bogus claims or using harmful ingredients.

On the other hand, companies in the tobacco industry that welcome strict FDA oversight invest significant amounts of research into the risks their products pose to individual and public health, the environment, and minors. Companies like Black Buffalo are eager to meet FDA guidelines for quality and safety; and they offer products that people who love dip or are looking to quit can count on, to be made with their interests in mind.

Challenges in Regulation

Despite the fact that anti-tobacco messaging has been telling us that tobacco is hazardous to our health since the late 1960s, the FDA only recently took control of regulating the industry. In the interest of protecting American consumers, the administration declared nicotine a drug, asserting jurisdiction over all tobacco products in 1995. 

Big Tobacco fought the decision, and the Supreme Court ruled regulation unconstitutional just five years later. It was not until 2009, when Congress passed its own legislation, that the FDA was finally allowed to fully provide oversight to roll-your-own and smokeless tobacco, as well as cigarettes. 

A 2016 ruling by a district court ultimately declared that the administration also had regulatory power over e-cigarettes, hookahs, and tobacco alternatives. Companies that made these products would have to submit a Pre-Market Tobacco Application (PMTA), making ingredients, processing and manufacturing techniques, and marketing strategies clear to the FDA. They had until September 1, 2020 to submit their application.

Regulatory enforcement, however, is still in question. The FDA has a year to review all the applications that it receives, but the administration will likely not finish in time. With so many products on the market and depleted resources as a result of COVID, as well as constantly-changing leadership, it is unclear how the FDA will keep non-compliant products off of store shelves.

Many companies may end up milking their time without oversight, flying under the FDA’s radar for as long as possible. This means that consumers could remain unprotected for the foreseeable future, in spite of the administration’s best efforts. 

Black Buffalo is Looking Out For its Customers

Black Buffalo cares about offering consumers the best possible products that are fully in compliance with the requirements set forth by the FDA. The team worked with attorneys, researchers, and consultants to put together an application that meets or exceeds the standards for its three pouch-format tobacco alternative products and five long-cut tobacco alternative products. These products are completely free of tobacco leaves and stems, and they deliver medical-grade nicotine without compromising taste or texture. 

While the company’s application has yet to be reviewed, Black Buffalo has invested extensively in submitting all the elements required for approval. These include product ingredient risk assessments; complete manufacturing and supply chain information; in-vitro toxicology testing; product perception and user intention analysis; clinical studies; marketing, packaging, and postmarket surveillance reviews; population impact studies; a thorough scientific literature review; and environmental assessments.

The Best of Both Worlds

When the tobacco industry was unregulated, the whole market was essentially a free-for-all. FDA oversight for tobacco protects consumers from bogus or inflated claims, and from excessively harmful products. It creates guidelines for companies to follow that increase transparency and consumer awareness, and it gives consumers the security of knowing they can count on ingredients lists and claims to be honest.

Black Buffalo is the first smokeless tobacco alternative maker to give dip lovers everywhere a product that truly satisfies while maintaining concern for compliance. Most products in this category that are in compliance with FDA policies do not actually replicate the chew that users love, making it difficult to quit tobacco for good. But Black Buffalo is different.

Not only has the company submitted its PMTA to the FDA for market authorization, demonstrating its care for customers, but it also makes the most authentic tobacco-free chew around. Though the company has not yet been reviewed by the administration, it has taken the steps necessary to protect consumers that are looking to keep everything they love about their dip, while ditching the tobacco.

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