I sent them a stern letter. They will ignore it. They will say; "Almost everyone is willing to compromise except for the lunatic fringe, who are easily recognized by their reference to the archaic concept 'liberty'."
Then they will compromise.
Then they will move the goalposts.
I always like to gather as much information as I can before forming an opinion. Since I was reading through the proposed rule anyway, I thought it may be helpful for me to pull out the most pertinent information and share it here. The full proposal can be found here: http://www.regulations.gov/#!documentDetail;D=FDA-2014-N-0189-0001
In short, the proposal is to add a variety of tobacco and tobacco related products to the list of products that can be regulated under the Food Drug and Cosmetic Act (FD&C Act). Products like cigarettes and roll your own tobacco are already covered under this act, and the proposal is to include a broader range of tobacco products to the list of "deemed products." This would include cigars (the reason we're all here), hookah tobacco, smokeless tobacco, etc., as well as a variety of non-tobacco products like e-cigarettes, dissolvables, filters, and flavor additives (flavored hookah coals, which I didn't even know existed). Accessories like lighters, cutters, and storage devices are exempt.
"Once finalized, products deemed under this rule will be subject to the
same FD&C Act provisions that cigarettes, roll-your-own tobacco, and
smokeless tobacco are subject to, with respect to the following: (1)
Enforcement action against products determined to be adulterated and
misbranded; (2) required submission of ingredient listing and reporting
of harmful and potentially harmful constituents (HPHCs) for all tobacco
products; (3) required registration and product listing for all tobacco
products; (4) prohibition against use of modified risk descriptors
(e.g., “light,” “low,” and “mild” descriptors) and claims unless FDA
issues an order permitting their use; (5) prohibition on the
distribution of free samples (same as for cigarettes); and (6) premarket
review requirements." ^These are the specific provisions that deemed products would be subject to. Of course, this list could change in the future, if the FD&C is modified.
The proposal contains two options for regulation. Under option 1, all cigars would be subject to FDA regulations. Under Option 2, "premium cigars" are exempt from regulation. "1. As noted previously, given that different kinds of cigars may have
the potential for varying effects on public health, FDA is proposing two
options for the categories of cigars that would be covered by this
rule. FDA is specifically seeking comment on whether all cigars should
be subject to deeming and what provisions of the proposed rule may be
appropriate or not appropriate for different kinds of cigars. ... 10. FDA is proposing that any cigar that is sold in product packaging
bear a health warning that would be randomly displayed and distributed
on cigar product packages and rotated in advertisements. In addition,
FDA is proposing that warnings for cigars sold individually and not
within productpackages all be included on a sign located at the
point-of-sale at each cash register in any retail establishment where
such cigars are sold. FDA requests comment as to whether all cigars sold
without product packaging, including those cigars we refer to as
“premium cigars,” should be exempt from the warning requirements.
11. As explained in the Initial Regulatory Flexibility Analysis, FDA
finds that this rule would have a significant economic impact on a
substantial number of small entities. FDA is seeking comments about any
unique challenges faced by small manufacturers of proposed deemed
tobacco products and how they should be addressed."
^ These are the some specific topics on which the FDA is seeking comment.
"Under Option 2, the proposed rule would extend FDA's authority to a
subset of cigars (defined as “covered cigars”) and to other products
meeting the definition of “tobacco product,” except the accessories of
such products. In order to define the products that would be subject to
this approach, FDA would propose to define a covered cigar to mean: any
cigar as defined in this part, except a cigar that: (1) Is wrapped in
whole tobacco leaf; (2) contains a 100 percent leaf tobacco binder; (3)
contains primarily long filler tobacco; (4) is made by combining
manually the wrapper, filler, and binder; (5) has no filter, tip, or
non-tobacco mouthpiece and is capped by hand; (6) has a retail price
(after any discounts or coupons) of no less than $10 per cigar
(adjusted, as necessary, every 2 years, effective July 1st, to account
for any increases in the price of tobacco products since the last price
adjustment); (7) does not have a characterizing flavor other than
tobacco; and (8) weighs more than 6 pounds per 1000 units." ^This is the way the FDA proposes to define "premium cigars." I have bolded the verbiage related to pricing, but a cigar must meet all these requirements in order to be exempt from regulation. Number 7 may give pause to any fans of infused cigars.
Is this proposed definition of “covered cigar”
appropriate to capture those products that, because of how they are
used, may have less of a public health impact than other types of
cigars?
Should long filler tobacco content be included as one of required
elements of a “premium” cigar (excluded from the definition of a
“covered cigar”)? If so, what percentage of the tobacco contained in the
cigar should be required to be long filler tobacco in order for the
cigar to be considered “premium”?
Is it appropriate to include the $10 price point in differentiating
“premium” cigars from other cigars? Please provide any data or
information that supports the selection of a $10 price point or, if you
believe a different price point is more appropriate, that supports the
selection of that price point.
Should a volume/rate restriction (e.g., “is produced at a rate of
no more than [insert number] units per minute”) be included as one of
required elements of a “premium” cigar (excluded from the definition of a
“covered cigar”)? If we were to include this restriction, what should
the rate be? How would FDA determine compliance with such a restriction?
Is it appropriate to include the proposed weight restriction (6
pounds per 1000 units) in differentiating “premium” cigars from other
cigars?
Would a different regulatory scheme for covered cigars, as defined
here, or other category of cigars adequately address the dangers of
tobacco use by adults or the proven dangers associated with use of
cigars (such as increased risk of several cancers even among those users
who do not inhale, and risk associated with lower levels of use as
discussed in section VII)?
How should the fact that studies indicate that young adults likely
prefer cigarillos, as opposed to traditional large cigars, affect FDA's
decision about whether to regulate “premium” cigars?
^These are the specific aspects of the definition for "premium cigar" on which the FDA is seeking comment.
I hope this is helpful in understanding the proposed rules. None of this is relevant if you object to regulation on ideological grounds. If the details matter to you, this may help you form an opinion.
Opinion time: It seems like an exemption for premium cigars is warranted, as the market for these products is fundamentally different from the broader tobacco market (also, I love them, and I selfishly don't want to pay more for them). The definition of "premium cigar" proposed seems too limited in relation to pricing, size, flavoring, and even filler composition. I'll send a comment along these lines.
That said, I don't see that all cigars will jump to $10.00 each if this goes through. Manufacturers will be subject to additional regulations, which will undoubtedly increase prices. For cigars close to $10.00, it may be cheaper for manufacturers to set an MSRP at or above $10.00 rather than comply with additional regulations for that particular product. It seems unlikely that the cost of compliance would be enough to bring a $5-$6 stick to $10.00. This may not be relevant to whether the proposal is justified, but it may help calm some fears.
Thank you for contacting me about the Traditional Cigar Manufacturing and Small Business Jobs Preservation Act (S. 772). I appreciate hearing from you.
In July 2009, President Obama signed into law the Family Smoking Prevention and Control Act (P.L. 111-31), which gives the Food and Drug Administration (FDA) the authority to regulate premium cigars and other tobacco products. As you may know, on April 18, 2013, Senator Bill Nelson (D-FL) introduced S. 772, of which I am proud to be a cosponsor. Among its provisions, this measure would exempt traditional large and premium cigars from the FDA's regulatory powers. I understand your concern with the effects increased regulation may have on access to premium cigars and employment in the cigar industry. S. 772 is currently pending before the Senate Committee on Health, Education, Labor, and Pensions for review. Like you, I am hopeful this measure will be signed by the President and enacted into law.
In addition, on August 8, 2014, I joined several of my Senate colleagues in urging the FDA to provide premium cigars a meaningful exemption in their proposed rule to deem additional tobacco products subject to regulation. Please know that I will keep your comments in mind as I continue to monitor this issue.
Thank you again for your correspondence. Please do not hesitate to contact me in the future if I can be of assistance.
Comments
In short, the proposal is to add a variety of tobacco and tobacco related products to the list of products that can be regulated under the Food Drug and Cosmetic Act (FD&C Act). Products like cigarettes and roll your own tobacco are already covered under this act, and the proposal is to include a broader range of tobacco products to the list of "deemed products." This would include cigars (the reason we're all here), hookah tobacco, smokeless tobacco, etc., as well as a variety of non-tobacco products like e-cigarettes, dissolvables, filters, and flavor additives (flavored hookah coals, which I didn't even know existed). Accessories like lighters, cutters, and storage devices are exempt.
"Once finalized, products deemed under this rule will be subject to the same FD&C Act provisions that cigarettes, roll-your-own tobacco, and smokeless tobacco are subject to, with respect to the following: (1) Enforcement action against products determined to be adulterated and misbranded; (2) required submission of ingredient listing and reporting of harmful and potentially harmful constituents (HPHCs) for all tobacco products; (3) required registration and product listing for all tobacco products; (4) prohibition against use of modified risk descriptors (e.g., “light,” “low,” and “mild” descriptors) and claims unless FDA issues an order permitting their use; (5) prohibition on the distribution of free samples (same as for cigarettes); and (6) premarket review requirements."
^These are the specific provisions that deemed products would be subject to. Of course, this list could change in the future, if the FD&C is modified.
The proposal contains two options for regulation. Under option 1, all cigars would be subject to FDA regulations. Under Option 2, "premium cigars" are exempt from regulation.
"1. As noted previously, given that different kinds of cigars may have the potential for varying effects on public health, FDA is proposing two options for the categories of cigars that would be covered by this rule. FDA is specifically seeking comment on whether all cigars should be subject to deeming and what provisions of the proposed rule may be appropriate or not appropriate for different kinds of cigars.
...
10. FDA is proposing that any cigar that is sold in product packaging bear a health warning that would be randomly displayed and distributed on cigar product packages and rotated in advertisements. In addition, FDA is proposing that warnings for cigars sold individually and not within productpackages all be included on a sign located at the point-of-sale at each cash register in any retail establishment where such cigars are sold. FDA requests comment as to whether all cigars sold without product packaging, including those cigars we refer to as “premium cigars,” should be exempt from the warning requirements.
11. As explained in the Initial Regulatory Flexibility Analysis, FDA finds that this rule would have a significant economic impact on a substantial number of small entities. FDA is seeking comments about any unique challenges faced by small manufacturers of proposed deemed tobacco products and how they should be addressed."
^ These are the some specific topics on which the FDA is seeking comment.
"Under Option 2, the proposed rule would extend FDA's authority to a subset of cigars (defined as “covered cigars”) and to other products meeting the definition of “tobacco product,” except the accessories of such products. In order to define the products that would be subject to this approach, FDA would propose to define a covered cigar to mean: any cigar as defined in this part, except a cigar that: (1) Is wrapped in whole tobacco leaf; (2) contains a 100 percent leaf tobacco binder; (3) contains primarily long filler tobacco; (4) is made by combining manually the wrapper, filler, and binder; (5) has no filter, tip, or non-tobacco mouthpiece and is capped by hand; (6) has a retail price (after any discounts or coupons) of no less than $10 per cigar (adjusted, as necessary, every 2 years, effective July 1st, to account for any increases in the price of tobacco products since the last price adjustment); (7) does not have a characterizing flavor other than tobacco; and (8) weighs more than 6 pounds per 1000 units."
^This is the way the FDA proposes to define "premium cigars." I have bolded the verbiage related to pricing, but a cigar must meet all these requirements in order to be exempt from regulation. Number 7 may give pause to any fans of infused cigars.
- Is this proposed definition of “covered cigar”
appropriate to capture those products that, because of how they are
used, may have less of a public health impact than other types of
cigars?
- Should long filler tobacco content be included as one of required
elements of a “premium” cigar (excluded from the definition of a
“covered cigar”)? If so, what percentage of the tobacco contained in the
cigar should be required to be long filler tobacco in order for the
cigar to be considered “premium”?
- Is it appropriate to include the $10 price point in differentiating
“premium” cigars from other cigars? Please provide any data or
information that supports the selection of a $10 price point or, if you
believe a different price point is more appropriate, that supports the
selection of that price point.
- Should a volume/rate restriction (e.g., “is produced at a rate of
no more than [insert number] units per minute”) be included as one of
required elements of a “premium” cigar (excluded from the definition of a
“covered cigar”)? If we were to include this restriction, what should
the rate be? How would FDA determine compliance with such a restriction?
- Is it appropriate to include the proposed weight restriction (6
pounds per 1000 units) in differentiating “premium” cigars from other
cigars?
- Would a different regulatory scheme for covered cigars, as defined
here, or other category of cigars adequately address the dangers of
tobacco use by adults or the proven dangers associated with use of
cigars (such as increased risk of several cancers even among those users
who do not inhale, and risk associated with lower levels of use as
discussed in section VII)?
- How should the fact that studies indicate that young adults likely
prefer cigarillos, as opposed to traditional large cigars, affect FDA's
decision about whether to regulate “premium” cigars?
^These are the specific aspects of the definition for "premium cigar" on which the FDA is seeking comment.I hope this is helpful in understanding the proposed rules. None of this is relevant if you object to regulation on ideological grounds. If the details matter to you, this may help you form an opinion.
Opinion time: It seems like an exemption for premium cigars is warranted, as the market for these products is fundamentally different from the broader tobacco market (also, I love them, and I selfishly don't want to pay more for them). The definition of "premium cigar" proposed seems too limited in relation to pricing, size, flavoring, and even filler composition. I'll send a comment along these lines.
That said, I don't see that all cigars will jump to $10.00 each if this goes through. Manufacturers will be subject to additional regulations, which will undoubtedly increase prices. For cigars close to $10.00, it may be cheaper for manufacturers to set an MSRP at or above $10.00 rather than comply with additional regulations for that particular product. It seems unlikely that the cost of compliance would be enough to bring a $5-$6 stick to $10.00. This may not be relevant to whether the proposal is justified, but it may help calm some fears.
More information is always a good thing.
-------------------------------------------------------
Dear Douglas,
Thank you for contacting me about the Traditional Cigar Manufacturing and Small Business Jobs Preservation Act (S. 772). I appreciate hearing from you.
In July 2009, President Obama signed into law the Family Smoking Prevention and Control Act (P.L. 111-31), which gives the Food and Drug Administration (FDA) the authority to regulate premium cigars and other tobacco products. As you may know, on April 18, 2013, Senator Bill Nelson (D-FL) introduced S. 772, of which I am proud to be a cosponsor. Among its provisions, this measure would exempt traditional large and premium cigars from the FDA's regulatory powers. I understand your concern with the effects increased regulation may have on access to premium cigars and employment in the cigar industry. S. 772 is currently pending before the Senate Committee on Health, Education, Labor, and Pensions for review. Like you, I am hopeful this measure will be signed by the President and enacted into law.
In addition, on August 8, 2014, I joined several of my Senate colleagues in urging the FDA to provide premium cigars a meaningful exemption in their proposed rule to deem additional tobacco products subject to regulation. Please know that I will keep your comments in mind as I continue to monitor this issue.
Thank you again for your correspondence. Please do not hesitate to contact me in the future if I can be of assistance.
Sincerely,
Pat Toomey
U.S. Senator, Pennsylvania
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