News: FDA Issues Deeming Regulations

Today the FDA released the regulations they wish to be put in place. The 241 page document can be read here.

While we do not speak for the industry as a whole the guidelines are not as damaging as the worst case scenario. There are however some issues that can change how business is done.

One is that samples can no longer be given. Does this include at the trade show, and what about product for press such magazines and bloggers. Will a sales person be able to give a cigar to a store owner or clerk?

But perhaps the biggest issue is

Manufacturers would be required to register all their products and ingredients with the FDA. They would only be able to market new products after an FDA review, and they would need to provide scientific evidence before making any claims of direct or implied risk reduction associated with their product.

Will this slow down the release of limited edition cigars? How will this effect the little guy and his ability to get a cigar on the market. Lastly, how long is the review process?

There are still a lot of questions that need to be asked and consequently answered but we all should breathe a sigh of relief that the initial proposed guidelines aren’t as bad as it could have been.

Now that we know what we face we must continue to fight and never surrender.