Hirsute
Used to have fun with Commander Yellow Pantyhose
Gents,
We've known that increased federal regulation of tobacco products was coming. Well, it's here.
Today the FDA published the final rule for pipe tobacco and cigars. You can read the regulation through a link on the Federal Register page here:
https://www.federalregister.gov/art...-food-drug-and-cosmetic-act-as-amended-by-the
The posting is 499 page pdf, so it's a lot to wade through. I'm a lawyer and dig this kind of stuff, so I've gone through it quickly and pulled out some highlights (or lowlights if you like):
- FDA regulations that already apply to cigarettes, RYO tobacco, and smokeless tobacco are extended to 6 additional product categories, and "include currently marketed products such as dissolvables notalready regulated by FDA, gels, waterpipe tobacco, ENDS* (including e-cigarettes, e-hookah, ecigars,vape pens, advanced refillable personal vaporizers, and electronic pipes), cigars, and pipetobacco." *ENDS are Electronic Nicotine Delivery Systems
- The rule also deems any future new products not currently marketed to be covered by the regulations, such as nicotine nasal sprays, etc.
- The FDA selected "Option 1" of their proposed rule which DOES NOT exempt premium cigars (Option 2 would have exempted premium cigars).
- manufacturers of tobacco products must submit ingredient lists and report HPHC (harmful and potentially harmful constituents) for each product
- new products must be reviewed by the FDA before they can be marketed.
- after the effective date, no one may manufacture for sale or distribution in the US any product that does not comply with the rule;
- 30 days after the effective date, a manufacturer may not introduce into domestic commerce any product, regardless of the date of manufacture, that does not comply with the rule;
- after the effective date, a distributor or retailer may not sell, offer to sell, distribute, or import for sale or distribution in the US any product whose package does not comply with the regulation unless the product was manufactured prior to the effective date
- The rule allows some staggered grandfathering: manufacturers of newly deemed tobacco products will have 12, 18, or 24 month initial compliance period in which to prepare applications for marketing authorization as well as 12-month continued compliance period; essentially, companies have 24, 30, or 36 months to comply with premarketing compliance rules.
- Manufacturers can apply to establish that a tobacco product was commercially marketed as of Feb 15, 2007, or that the product is substantially similar to a product marketed as of that date
- The FDA has rules specifically addressing small-scale manufacturers, which the rule defines as "a manufacturer of any regulated tobacco product that employs 150 or fewer full-timeequivalent employees and has annual total revenues of $5,000,000 or less." The FDA will not target small-scale manufacturers for enforcement during the 12 months after the rule, and will provide additional time and assistance for them to comply with the regulations.
The FDA received over 135,000 comments on the proposed rule before deciding on this final rule.
This is essentially the last step in the regulatory rule-making process, and the rule will go into effect 90 days from the date of publication in the Federal Register.
Also, the FDA is slated to post regulations regarding e-cigarettes tomorrow, so more news to come.
Let the mad rush to the store and hoarding of favorite products begin...
(Oh, and I feel obliged to mention that civil discussion of political topics is allowed in the forums, but if the discussion becomes too sharp the mods will shut this thread down, so let's keep it civil gents)
We've known that increased federal regulation of tobacco products was coming. Well, it's here.
Today the FDA published the final rule for pipe tobacco and cigars. You can read the regulation through a link on the Federal Register page here:
https://www.federalregister.gov/art...-food-drug-and-cosmetic-act-as-amended-by-the
The posting is 499 page pdf, so it's a lot to wade through. I'm a lawyer and dig this kind of stuff, so I've gone through it quickly and pulled out some highlights (or lowlights if you like):
- FDA regulations that already apply to cigarettes, RYO tobacco, and smokeless tobacco are extended to 6 additional product categories, and "include currently marketed products such as dissolvables notalready regulated by FDA, gels, waterpipe tobacco, ENDS* (including e-cigarettes, e-hookah, ecigars,vape pens, advanced refillable personal vaporizers, and electronic pipes), cigars, and pipetobacco." *ENDS are Electronic Nicotine Delivery Systems
- The rule also deems any future new products not currently marketed to be covered by the regulations, such as nicotine nasal sprays, etc.
- The FDA selected "Option 1" of their proposed rule which DOES NOT exempt premium cigars (Option 2 would have exempted premium cigars).
- manufacturers of tobacco products must submit ingredient lists and report HPHC (harmful and potentially harmful constituents) for each product
- new products must be reviewed by the FDA before they can be marketed.
- after the effective date, no one may manufacture for sale or distribution in the US any product that does not comply with the rule;
- 30 days after the effective date, a manufacturer may not introduce into domestic commerce any product, regardless of the date of manufacture, that does not comply with the rule;
- after the effective date, a distributor or retailer may not sell, offer to sell, distribute, or import for sale or distribution in the US any product whose package does not comply with the regulation unless the product was manufactured prior to the effective date
- The rule allows some staggered grandfathering: manufacturers of newly deemed tobacco products will have 12, 18, or 24 month initial compliance period in which to prepare applications for marketing authorization as well as 12-month continued compliance period; essentially, companies have 24, 30, or 36 months to comply with premarketing compliance rules.
- Manufacturers can apply to establish that a tobacco product was commercially marketed as of Feb 15, 2007, or that the product is substantially similar to a product marketed as of that date
- The FDA has rules specifically addressing small-scale manufacturers, which the rule defines as "a manufacturer of any regulated tobacco product that employs 150 or fewer full-timeequivalent employees and has annual total revenues of $5,000,000 or less." The FDA will not target small-scale manufacturers for enforcement during the 12 months after the rule, and will provide additional time and assistance for them to comply with the regulations.
The FDA received over 135,000 comments on the proposed rule before deciding on this final rule.
This is essentially the last step in the regulatory rule-making process, and the rule will go into effect 90 days from the date of publication in the Federal Register.
Also, the FDA is slated to post regulations regarding e-cigarettes tomorrow, so more news to come.
Let the mad rush to the store and hoarding of favorite products begin...
(Oh, and I feel obliged to mention that civil discussion of political topics is allowed in the forums, but if the discussion becomes too sharp the mods will shut this thread down, so let's keep it civil gents)
