- Apr 2, 2009
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It looks like Indiana's legislature will soon repeal the monopoly law.
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Indiana Call to Action - Stop the Monopoly
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- Apr 2, 2009
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The conference committee's goal is to work out the differences in the Senate and House approved bills.
I don't see any major differences, and was surprised the Senate didn't agree to the House approved bill.
I don't see any major differences, and was surprised the Senate didn't agree to the House approved bill.
True Bill, that is the theoretical goal of the conference committee. I would have more confidence in this process if the senate had agreed to the House bill instead of passing it to conference. There have been odd things that have happened in conference, in the past, which gives me concerns.
The big thing going for us is the Senate leadership is pushing this hard. As long as that does not waiver, it looks good. I do not want to discount the money and connected people who got the horrible law passed in the first place because they still exist and have even more lobbyists than they did in 2015. We, the Hoosier Vapers, plan on being at the statehouse until the end. It is not time to let our guard down yet.
The big thing going for us is the Senate leadership is pushing this hard. As long as that does not waiver, it looks good. I do not want to discount the money and connected people who got the horrible law passed in the first place because they still exist and have even more lobbyists than they did in 2015. We, the Hoosier Vapers, plan on being at the statehouse until the end. It is not time to let our guard down yet.
I'm getting confusing messages from folks in the committee room. What I'm getting is confusing because some of our calmer heads, not me in that classification, are really "kissed" off.
Kissed just ryhmes....
Kissed just ryhmes....
It sounds like some folks don't realize that jail time might be in their future.
Giving up their "fight" would be very wise on their part.
As predicted it looks like they're trying to get ....y with it.
Issues with vaping law left unresolved
Issues with vaping law left unresolved
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Right you are Verb. Odd to be addressing new subjects in conference instead of homogenization of the two slightly different versions of the bill.
The "face to face" is the most peculiar. How would the state intend to monitor the US mail? They have been smacked in courts for overreach already and have a pending FIB investigation over the 2015 law, but they think it's a good idea to go into mail now?
Someone thinks this will protect the current monopoly members or serve as a stalking tactic or maybe drain more money from us on court cases...or maybe all of that?
This device autocorrects ...... to either missed or kissed, sigh.
There is other stupidity being said in the conference which is all not typical.
The "face to face" is the most peculiar. How would the state intend to monitor the US mail? They have been smacked in courts for overreach already and have a pending FIB investigation over the 2015 law, but they think it's a good idea to go into mail now?
Someone thinks this will protect the current monopoly members or serve as a stalking tactic or maybe drain more money from us on court cases...or maybe all of that?
This device autocorrects ...... to either missed or kissed, sigh.
There is other stupidity being said in the conference which is all not typical.
Bill's positive thoughts seems to have worked!
The monkey business stopped and SB1 is out of conference and starting the process to get to the governor's desk.
I doubt all those articles exposing the true origin of the vaping law had anything to do with the monkey business being abandoned like a flaming car.
The monkey business stopped and SB1 is out of conference and starting the process to get to the governor's desk.
I doubt all those articles exposing the true origin of the vaping law had anything to do with the monkey business being abandoned like a flaming car.
- Apr 2, 2009
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Indiana House and Senate enact Conference Committee Report on bill (S-1) to repeal Indiana e-liquid monopoly law, goes to Governor
Senate Bill 1 - E-liquids
Since the House and Senate votes on S-1 were veto proof super majorities,
I strongly suspect the Governor will sign the bill into law.
I think Congratulations are now in order.
Senate Bill 1 - E-liquids
Since the House and Senate votes on S-1 were veto proof super majorities,
I strongly suspect the Governor will sign the bill into law.
I think Congratulations are now in order.
- Apr 2, 2009
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From Azim Chowdhury
Summary of Manufacturer Requirements in Indiana SEA 1
I. Key Definitions
II. ATC Permit Requirements
III. Packaging and Labeling Requirements
IV. Ingredient Requirements
V. Facility Inspections for Manufacturers and Contract Manufacturers
VI. Annual Reporting Requirements
VII. Penalties
Summary of Manufacturer Requirements in Indiana SEA 1
I. Key Definitions
- E-Liquid - A substance that (1) may or may not contain nicotine and (2) is intended to be vaporized or inhaled using a vapor product. [Note this includes zero-nicotine e-liquids.]
- Manufacturer - a person located inside or outside Indiana that is engaged in manufacturing e-liquid.
- Manufacturing - the process by which an e-liquid is mixed, bottled, and packaged.
- Vapor Product - a powered vaporizer that converts e-liquid to a vapor intended for inhalation. [Note that SEA 1 does not apply to "closed system" vapor products except for certain labeling and reporting requirements detailed below.]
II. ATC Permit Requirements
- A manufacturer of e-liquid may not mix, bottle, package, or sell e-liquid to retailers, consumers, or distributors in Indiana without a permit issued by the ATC.
- A manufacturing permit issued by the ATC is valid for five (5) years and must include the following:
- The name, telephone number, and address of the applicant.
- The name, telephone number, and address of the manufacturing facility.
- The name, telephone number, title, and address of the person responsible for the manufacturing facility.
- Verification that the facility will comply with applicable tobacco products good manufacturing practices promulgated under 21 U.S.C. 387f(e) of the federal Food, Drug, and Cosmetic Act. [Note no federal GMPs have been established yet.]
- Verification that the manufacturer will comply with the applicable ingredient listing required by 21 U.S.C. 387d(a)(1) of the federal Food, Drug, and Cosmetic Act. [For a summary of the FDA ingredient reporting process, see Keller and Heckman's alert here and upcoming May 9, 2017 complimentary webinarhere.]
- Written consent allowing the state police department to conduct a state or national criminal history background check on any person listed on the application. ATC will forward a copy of the permit application to the state police department for state or national background checks; ATC is required to cover the cost of the background check. [Note that the permit will be denied if the manufacturer or any person listed on the application has been convicted of various federal crimes or Indiana felonies set forth in the statute within ten (10) years before the date of the application.]
- A nonrefundable initial application fee of one thousand dollars ($1,000). The five year renewal application fee is $500.
- If a completed application for a permit is denied, ATC must state the reasons for the denial. The applicant may reapply within thirty (30) days after the date of the denial. There is no application fee for a reapplication.
III. Packaging and Labeling Requirements
- An e-liquid container must use a child proof cap that has the child resistant effectiveness set forth in the federal poison prevention packaging standards, 16 CFR 1700.15(b)(1). [For more on the federal child-resistant packaging requirements for e-liquid containers, see Keller and Heckman's alert here.]
- An e-liquid container must use a tamper evident package, which is defined as a package having at least one (1) indicator or barrier to entry that, if breached or missing, can reasonably be expected to provide visible evidence to consumers that tampering has occurred. The tamper evident package feature must be designed to and remain intact when handled in a reasonable manner during the manufacture, distribution, and retail display of the e-liquid container.
- The label on an e-liquid container must meet the nicotine addictiveness warning statement requirements set forth in 21 CFR 1143.3 ("WARNING: THIS PRODUCT CONTAINS NICOTINE. NICOTINE IS AN ADDICTIVE CHEMICAL."). That nicotine warning must be present on the label or container by May 31, 2018.
- E-liquid labels or containers must also include an identifiable and trackable code, the manufacturing date and the Indiana e-liquid manufacturing permit number. This requirement also applies to closed system vapor products.
- E-Liquid labels should not contain any claims of "modified risk" (i.e., this product is less harmful than smoking or cigarettes). A Modified Risk Tobacco Product is defined to mean any tobacco product that is sold or distributed to reduce harm or the risk of tobacco related disease associated with commercially marketed tobacco products. [Note this is slightly different than the definition in the Tobacco Control Act, see here.] A manufacturer, distributor, or retailer may not market e-liquid with claims of modified or reduced risk that has not been designated as a Modified Risk Tobacco Product by FDA.
IV. Ingredient Requirements
- A manufacturer or retailer may not add an adulterated product to any e-liquid produced for sale in Indiana. Under the new law, a product is "adulterated" if it (a) consists in whole or in part of any filthy, putrid, or decomposed substance; or (b) is contaminated by any added poisonous or added deleterious substance that may render the product injurious to health.
- A manufacturer may use any "flavoring" as an ingredient in an e-liquid. A flavoring is defined as a food grade additive or synthetic flavoring substance that is used to add flavor, and that is not prohibited by FDA as an additive in vapor products.
- Note that Indiana retailers are prohibited from selling e-liquid that contains more than seventy-five (75) milligrams per milliliter of nicotine.
V. Facility Inspections for Manufacturers and Contract Manufacturers
- A manufacturer must submit to random site visits by ATC. The manufacturer may: (a) own and control both the e-liquid manufacturing process and the bottling process; or (b) subcontract with another manufacturer for the performance of the e-liquid manufacturing service, the bottling services, or both services. Both entities must meet the requirements of the law. In other words, both types of manufacturers may be subjected to random visits by the ATC.
VI. Annual Reporting Requirements
- E-liquid manufacturers must annually submit confidential reports to the ATC setting forth:
- Each new product that a manufacturer is producing and selling in Indiana with a list of the contents and ingredients by volume, and whether the manufacturer has stopped producing products previously produced and sold in Indiana, unless amanufacturer (for both open and closed system vapor products) submits to the ATC a certification, by October 1 of each year, that each of the manufacturer's vapor products sold in Indiana has been "filed" with FDA.
- Although not entirely clear at this point, a product being "filed" with FDA may be a product that, if manufactured in the U.S., is listed as part of a U.S. manufacturing establishment registration (see Keller and Heckman FDA registration client alert here), or whose ingredients have been listed with FDA.
- The milligrams per milliliter of nicotine in each product the manufacturer produces; and the milliliters of each product sold that current year.
VII. Penalties
- If a manufacturer, distributor, or retailer violates the new law, the manufacturer, distributor, or retailer may be reprimanded, assessed a civil penalty, or have the manufacturer's permit, distributor's license, or retailer's tobacco sales certificate suspended.
- ATC may assess a civil penalty against a manufacturer, distributor, or retailer for a violation of the new law in an amount that does not exceed ten thousand dollars ($10,000). A civil penalty may be assessed in addition to other penalties allowed under this article.
It is awesome..... one less reason for me wanting to move far away from this state.
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