Last night I must of fielded about 2 dozen text messages and at least that many private messages on Facebook asking what the FDA regulations are and what is the OMB. I’ll be honest with you a lot of the process is something I had to research and teach myself last night but here goes…
We have known that the FDA was looking to regulate cigars, pipe tobacco, e-cigarettes, hookah and more since April of 2014. The process has been on going for a couple of years and it all came to a head last year when the FDA proposed the Deeming Regulations which was made public and was open to a public commenting period.
The nine step process of having such regulations put into place moves into step number 8 with the White House Office of Management & Budget (OMB) receiving the final deeming regulations. These regulations could have changed from that which was made public last year as the FDA, although unlikely, listened to the comments.
Once the OMB has the regulations they have 90 days to review the FDA recommendations and if needed they can request a 30 day extension. We learned yesterday from Cigar Rights of America that the FDA has requested that this matter be expedited so therefore it could be much quicker than that.
Once changes are made by the OMB, if any, step 9 would be the publication of the final rule and it would go into effect 30 days after that. However, there is sure to be lawsuits that will attempt to delay the enforcement and attempts to have changes made.
There are two options that are a possibility.
Option 1: This would regulate all cigars, pipe tobacco, electronic cigarettes, nicotine gels, hookah tobacco and dissolvables, except accessories of a tobacco product.
Option 2: would regulate these six categories of tobacco products, but exempt premium cigars and tobacco product accessories from regulations. Exempt accessories would include such items as lighters, cigar cutters, humidors and cases. The initial FDA document defined premium cigars as having a minimum cost of $10.00
According to the National Association of Tobacco Outlets (NATO), the FDA has proposed nine kinds of regulations that are currently already applicable to cigarettes, RYO and chewing tobacco. If Option 1 is passed, these 9 regulations would apply to all the categories listed above. Option 2 would exempt the premium cigars from these regulations.
- Manufacturers would be required to register each of their tobacco manufacturing facilities with the FDA, and report any harmful and potentially harmful constituents.
- Manufacturers would be required to submit a list of the tobacco products they produce and a list of ingredients in each product.
- Modified risk descriptors such as “light,” “low” and “mild” could not be used to describe a regulated tobacco product.
- Free samples of the deemed tobacco products would not be allowed.
- For e-cigarettes and other newer novel tobacco products that were not on the market as of Feb. 15, 2007, manufacturers of these products would need to submit a premarket tobacco application (PMTA) to the FDA within 24 months following the effective date of the final deeming regulations. If a PMTA application is filed with the FDA during this 24-month period, then the manufacturer can continue to market its products unless and until the FDA responds to the application. The PMTA process allows the FDA to authorize the introduction of products into the market where appropriate for the protection of the public health and prevent introduction of products that are detrimental to the public health.
- FDA enforcement actions can be taken against manufacturers whose tobacco products are determined to be adulterated or misbranded.
- The minimum age to purchase deemed tobacco products would be 18 years old and retailers would be required to verify through photographic identification the legal minimum age of a customer who is younger than 27 years old.
- A new health warning would be required on all deemed tobacco products, plus all cigarette tobacco and roll-your-own tobacco, and in all advertisements for these tobacco products. This warning would read: “WARNING: This product contains nicotine derived from tobacco. Nicotine is an addictive chemical.”This new health warning would not be required for cigarettes or smokeless tobacco products because federal law already requires health warnings on these two products. However, this new health warning would be required on advertisements created by retailers for deemed tobacco products, cigarette tobacco and RYO tobacco.
- A prohibition on the sale of the deemed tobacco products through vending machines, unless the machine is located in an adult only facility.
