FDA FDA Guidelines: Establishing That a Tobacco Product Was Commercially Marketed in the United States as of February 15, 2007

[AgentAnia]

Have not read it yet, so post it here FYI w/o comment: http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM416498.pdf

 

[aikanae1]

I hadn't seen that before. It seems to exclude ecigs.

GuidanceComplianceRegulatoryInformation/UCM416498.pdf
These finished, regulated tobacco products include the tobacco products named in section 901(b) of the FD&C Act (i.e., cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco) and tobacco products deemed by regulation to be regulated under Chapter IX, as well as the component parts of regulated tobacco products sold or distributed for consumer use (e.g., cigarette rolling papers, filters, or filter tubes sold separately to consumers or as part of kits). FDA does not intend to review grandfathered status for component parts of regulated tobacco products that are sold or distributed solely for further manufacturing into finished tobacco products because at this time the Agency does not intend to enforce the requirements of sections 910 and 905(j) of the FD&C Act for these components.6

The time required to complete this information collection is estimated to average 5 hours per response, including the time to review instructions, search existing data sources, gather the data needed, and complete and review the information collection. Send comments regarding this burden estimate or suggestions for reducing this burden to: Food and Drug Administration, Center for Tobacco Products, Document Control Center, Building 71, Room G335, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002.

 

[Kent C]

Interesting....

"B. What is a new tobacco product?

A new tobacco product is defined in section 910(a)(1) of the FD&C Act 3 as:
(A)
any tobacco product (including those products in test markets) that was not commercially marketed in the United States as of February 15, 2007; or
(B)
any modification (including a change in design, any component, any part, or any constituent, including a smoke constituent, or in the content, delivery or form of nicotine, or any other additive or ingredient) of a tobacco product where the modified product was commercially marketed in the United States after February 15, 2007.

In general, a tobacco product manufacturer must obtain an order under section 910(c)(1)(A)(i) (order after review of a premarket application) before the manufacturer may introduce a new tobacco product into interstate commerce (section 910 of the FD&C Act). An order under section 910(c)(1)(A)(i) is not required, however:
•
•
if a manufacturer submits a substantial equivalence report under section 905(j) of the FD&C Act 4 (a 905(j) report) and obtains an order under section 910(a)(2)(A)(i); or

if FDA has granted a substantial equivalence exemption request submitted under 21 CFR 1107.1 and the manufacturer submits the required report under section 905(j)."

---

21 CFR 1107.1

Exemption Questions & Answers

What information must be included in a request for exemption from the substantial equivalence requirements?

The request for an exemption from substantial equivalence must include the information described in 21 CFR 1107.1(b)21, including all the following:

The manufacturer’s address and contact information
Identification of the tobacco product
A detailed explanation of the purpose of the modification
A detailed explanation of why a Substantial Equivalence Report is not necessary to ensure that permitting the tobacco product to be marketed would be appropriate for protection of the public health
A certification signed by a responsible official of the manufacturer summarizing the supporting evidence and providing the rationale for the official’s determination that the modification does not increase the tobacco product’s appeal to or use by minors, toxicity, addictiveness, or abuse liability
Other information justifying an exemption, and
An environmental assessment under part 25 of this chapter prepared in accordance with the requirements of 21 CFR 25.4022.

Could this be a 'loophole' for tobacco companies' cigalikes? Just wondering.... Sounds like an alternative for product applications - although with the environmental assessment - likely to entail some costs.

Can I submit a single exemption from substantial equivalence request for multiple tobacco products?


Manufacturers may submit one exemption from substantial equivalence request for multiple tobacco products if the request identifies the specific products and if the information submitted under 21 CFR 1107.1(b)27 applies to all the specified products.

A manufacturer may also submit an exemption request for a tobacco product(s) for a minor modification of an additive if the manufacturer specifies a range with a maximum and minimum as has been typically used for that individual tobacco product. Again, the request must include the information required in 21 CFR 1107.1(b)28 in order for FDA to make the necessary findings.

 

[dragonpuff]

I hadn't seen that before. It seems to exclude ecigs.

That's interesting because it was just published. They may be preparing for the possibility that the court will force them to exclude e-cigs from these regulations.... although, at the same time, they are also not mentioning anything else in this document that they consider a tobacco product (hookah, snuff, dissolvables, etc.).

 

[Jman8]

By FDA's definition, I see eCig products as new tobacco products.

Deemed this way after 2007, and thus bringing into question the integrity of FDA's approach to regulation, if not the integrity of FSPTCA.

If wanting to play by FDA rules and work with FDA, then I continue to see most viable solution, for all involved (including FDA), as moving the grandfather date. Best moved to the date that the final rule is in place, not including any extensions that FDA may grant specifically for eCig related products. So, that grandfather date could be, theoretically, 2 years after the final rule is in place.

If not wanting to go this route and instead challenge the FDA's ruling of eCigs as tobacco product, and essentially challenge integrity of FSPTCA, then I see court battles that will do this, and may win, whereby FDA is not able to deem eCig products a tobacco product. What happens then, exactly? I dunno.

 

[Kent C]

It goes like this:

There was an mini explosion of ecigs on the market.

FDA doesn't like that, so they confiscate products at customs under the idea that it was a drug device under their authority.

Ecig sellers filed suit.

Judge Leon says to the FDA, it's not under your authority.

Congress and Obama puts tobacco products under the FDA authority.

Ecigs now in a boom.

FDA issues the deeming doc, redefining ecigs as tobacco products, stating how now they are under their authority.

 

[LoveVanilla]

Oh [censored]........

 

[pamdis]

I hadn't seen that before. It seems to exclude ecigs.

GuidanceComplianceRegulatoryInformation/UCM416498.pdf
These finished, regulated tobacco products include the tobacco products named in section 901(b) of the FD&C Act (i.e., cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco) and tobacco products deemed by regulation to be regulated under Chapter IX, as well as the component parts of regulated tobacco products sold or distributed for consumer use (e.g., cigarette rolling papers, filters, or filter tubes sold separately to consumers or as part of kits). FDA does not intend to review grandfathered status for component parts of regulated tobacco products that are sold or distributed solely for further manufacturing into finished tobacco products because at this time the Agency does not intend to enforce the requirements of sections 910 and 905(j) of the FD&C Act for these components.6

The time required to complete this information collection is estimated to average 5 hours per response, including the time to review instructions, search existing data sources, gather the data needed, and complete and review the information collection. Send comments regarding this burden estimate or suggestions for reducing this burden to: Food and Drug Administration, Center for Tobacco Products, Document Control Center, Building 71, Room G335, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002.

Doesn't exclude anything.

 

[Bill Godshall]

Legally, this new guidance only pertains to cigarettes, RYO and smokeless tobacco unless and until FDA issues a Final Rule for its proposed Deeming Regulation, which almost certainly won't occur for at least another year (and hopefully will never occur).

But even if FDA issues the Final Rule for its proposed Deeming Regulation, I'd be shocked if the FDA accepted any SE report from an e-cig manufacturer (in the event that any e-cig manufacturer actually submits an SE report to the FDA, which I consider doubtful).

 

[bigdancehawk]

Legally, this new guidance only pertains to cigarettes, RYO and smokeless tobacco unless and until FDA issues a Final Rule for its proposed Deeming Regulation, which almost certainly won't occur for at least another year (and hopefully will never occur).

But even if FDA issues the Final Rule for its proposed Deeming Regulation, I'd be shocked if the FDA accepted any SE report from an e-cig manufacturer (in the event that any e-cig manufacturer actually submits an SE report to the FDA, which I consider doubtful).

Right. SE approval will be almost impossible to get. As has been pointed out in this forum about a million times, e-cigs are a square peg in the round hole of the enabling statute. It should be a simple matter of amending the statute to exempt e-cigs. Then they could pass some appropriate legislation. But I suspect that won't happen in my lifetime. Instead, our tax dollars will continue to be devoted to funding CDC and FDA "science-based" efforts to help smokers die prematurely.