FDA Sampling juice at B&M's

[Ed_C]

Out of all this, the "can no longer advocate" is maybe the most offensive. Being an advocate is not the same as making claims. So much for free speech. You see all the "snake oil" that gets peddled everyday, with no supporting research, whatsoever, and vaping gets singled out.

 

[sofarsogood]

Will there be a lot of passive resistance? There are millions of highly motivated vapers in the US and it's easy to share ideas. The club sounds interesting. The FDA wants to micro manage vaping but doesn't want to impose the controls usually needed to do that. Typically something would only be available by perscription then the doctor and druggest are accountable but we see how that system is used and abused. We sent them 100's of thousands of letters. Is it now the time to ask them 100's of thousands of questions?

Suppose I have a mod bought before 8-8 and I put in a fresh battery bought after 8-8. May be I violated the regulation by doing that. May be 10 or 20 or 50,000 vapers should be asking the FDAsses to answer that one for them. If I put new cotton in my rda have I created a new tobacco product? I think at LEAST 50,000 vapers need to ask that question. I rewick every few days. In fact I might be rewicking tomorrow so the answer is needed urgently.

Well then here's another one. I have a silicone sleve and a faux leather sleeve for the same mod. If I switch from one to the other have I violated the regulation? What about swaping out to a different drip tip? Who knows what could happen. Regardless, is it allowed by the regulations? If I make my own drip tip for perssonal use am I a tobacco manufacturer. There are a LOT of questions that need answering and everybody needs to be asking alll of them. There must be SO many unanswered questions, may be an infinite number, who knows. (end ramble, stop)

 

[VapNMirrors]

Selling juice samples doesn't make you a manufacturer, anymore than a restaurant pouring a Coke makes the restaurant a producer of Coke.

That's not true, under most interpretations it does. If the product is modified in any way, you're now a manufacturer. Just opening the bottle is enough.

This is also why just fiddling with your device is no longer provided by compliant shops.

BTW, here's a link to statements from Avail, the shop doing the private club loophole.

 

[Ed_C]

Under interpretations of the Deeming regulations or more general interpretations? I could buy that the bottle of juice has been modified to an extent and couldn't be sold as a new bottle if it had it's seal broken, but the juice itself has not been modified. Pouring it out for use doesn't make you a manufacturer, regardless of any convoluted legal definitions that may exist. imho

 

[Lessifer]

Under interpretations of the Deeming regulations or more general interpretations? I could buy that the bottle of juice has been modified to an extent and couldn't be sold as a new bottle if it had it's seal broken, but the juice itself has not been modified. Pouring it out for use doesn't make you a manufacturer, regardless of any convoluted legal definitions that may exist. imho

If component A(a CE4) is it's own product, and component B(ego battery) is it's own product, and e-liquid C is a tobacco product, combining ABC is it's own product. Or at least could be interpreted to be. Now, having droppers of liquid that the customer can drip into their own atomizer, no manufacturing going on there.

 

[Ed_C]

If component A(a CE4) is it's own product, and component B(ego battery) is it's own product, and e-liquid C is a tobacco product, combining ABC is it's own product. Or at least could be interpreted to be. Now, having droppers of liquid that the customer can drip into their own atomizer, no manufacturing going on there.

I guess I can sort of buy that logic. So the work around would be for juice makers to supply testers that are sealed, but since these aren't on the market, they would need to submit each tester for approval before it could be used in the market. Not very likely.

 

[B2L]

Maybe you could ask the FDA.
They are there to help.

 

[Ed_C]

I guess if you were to sell juice from a company who made prefilled cartos, like Halo, you might be OK?

 

[Lessifer]

I guess if you were to sell juice from a company who made prefilled cartos, like Halo, you might be OK?

I don't know. I'm still waiting for an official answer from the FDA. Depending on interpretation you could be "sampling" three components/products or more, but who knows what they think?

 

[Rossum]

Will there be a lot of passive resistance? There are millions of highly motivated vapers in the US and it's easy to share ideas. The club sounds interesting. The FDA wants to micro manage vaping but doesn't want to impose the controls usually needed to do that. Typically something would only be available by perscription then the doctor and druggest are accountable but we see how that system is used and abused. We sent them 100's of thousands of letters. Is it now the time to ask them 100's of thousands of questions?

Suppose I have a mod bought before 8-8 and I put in a fresh battery bought after 8-8. May be I violated the regulation by doing that. May be 10 or 20 or 50,000 vapers should be asking the FDAsses to answer that one for them. If I put new cotton in my rda have I created a new tobacco product? I think at LEAST 50,000 vapers need to ask that question. I rewick every few days. In fact I might be rewicking tomorrow so the answer is needed urgently.

Well then here's another one. I have a silicone sleve and a faux leather sleeve for the same mod. If I switch from one to the other have I violated the regulation? What about swaping out to a different drip tip? Who knows what could happen. Regardless, is it allowed by the regulations? If I make my own drip tip for perssonal use am I a tobacco manufacturer. There are a LOT of questions that need answering and everybody needs to be asking alll of them. There must be SO many unanswered questions, may be an infinite number, who knows. (end ramble, stop)

The problem with this approach is that it might give them the impression that we respect them and intend to abide by their arbitrary and capricious regulations.

 

[sofarsogood]

The problem with this approach is that it might give them the impression that we respect them and intend to abide by their arbitrary and capricious regulations.

Putting the FDA in charge of tobacco was a mistake because they cannot resist pressure from the very large number of people who benefit from tobacco money. Ecigs, free of government interference, can end tobacco use more effectively than anything the FDA could ever do. Perversely the FDA is now being used to prevent that.

 

[Lessifer]

So, they finally "answered" me, see below. Needless to say, I will be contacting them again for clarification.

Thank you for contacting the U.S. Food and Drug Administration (FDA) regarding its recently finalized rule, “Deeming Tobacco Products to be Subject to the Federal Food, Drug and Cosmetic Act,as Amended by the Family Smoking Prevention and Tobacco Control Act” (Deeming rule).


You asked about the lowest price that may be charged for sampling under the Deeming Rule for newly deemed products. In this rule, FDA is not modifying the existing restriction on distributing free samples of “tobacco products” (21 CFR 1140.16(d)), as defined under section 201(rr) of the FD&C Act. As a result, the prohibition on the distribution of free samples applies to all newly deemed tobacco products, including their components and parts, but not accessories. Allowing prospective adult buyers to smell or handle one of the newly deemed products is not considered distribution of a "free sample" as long as the product is not actually consumed, in whole or in part, in the retail facility for free and the prospective buyer does not leave the facility with a free tobacco product. We believe that in most circumstances, retail facilities, including electronic nicotine delivery systems (ENDS) retail establishments, can allow customers to touch, hold, and smell their products without violating the free sample ban. However, if the prospective buyer lights and draws, puffs on, or otherwise consumes the tobacco product, or leaves the retail establishment with a free tobacco product, this would constitute a "free sample" in violation of 21 CFR 1140.16.

For More Information

To assist the newly-regulated tobacco industry in complying with the requirements being announced, the FDA is also publishing several other regulatory documents that provide additional clarity, instructions and/or the FDA’s current thinking on issues specific to the newly-regulated products.

Final Rule and Accompanying Documents

• Final Rule: Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products
• Small Entity Compliance Guide: FDA Deems Certain Tobacco Products Subject to FDA Authority, Sales and Distribution Restrictions, and Health Warning Requirements for Packages and Advertisements
• Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems (ENDS); Draft Guidance for Industry
• Tobacco Product Master Files; Guidance for Industry

Resources for Additional Information

FDA continues to update its Deeming webpage to provide information designed to help industry understand the Deeming rule. We anticipate that many of your questions will be addressed by the resources available on this website. We have also created a chart that may help you determine which provisions apply to you and the timeframes for complying. In addition, FDA has posted Tobacco Compliance Webinars, including one specifically addressing requirements for vape shops, to our website and updates will be provided as additional webinars are available.


We also encourage you to subscribe to FDA’s “This Week in CTP.” By subscribing, you’ll receive updates about regulatory activities, retailer notices, upcoming events, and public education campaigns.


Should you have further questions after reviewing this information, you may contact CTP using the following communication methods:


Email:

SmallBiz.Tobacco@fda.hhs.gov

Phone:

1-877-287-1373

Mail:

Food and Drug Administration

Center for Tobacco Products

10903 New Hampshire Avenue

Silver Spring, MD 20993


--------------------------------------

Center for Tobacco Products

Food and Drug Administration

CTP Call Center: 1-877-CTP-1373

www.fda.gov/tobaccoproducts

 

[Ed_C]

Looks like they stated your question nicely, but then forgot to answer it. Nice.

 

[Lessifer]

Looks like they stated your question nicely, but then forgot to answer it. Nice.

Yeah, seriously. This was my initial email to them, that sparked the above response:
"It is clear that free samples are not allowed. How can a vapor store, that only allows customers of legal age to enter, allow customers to sample the liquids, meaning taste test using a vaporizer, in the store while staying within regulatory compliance? Would you have to charge per flavor sampled? Would a fee of say $1 for unlimited sampling during a visit suffice? Would this need to be a product tracked in inventory? Sampling is an important part of the retail vapor experience."

and I just now responded with:
"I've kept the below email chain for reference. My question was about customers TASTE testing samples in an e-liquid shop and what would be sufficient to conform to the no free samples restriction. Handling and smelling is not tasting. If a shop has vaporizers set up, with e-liquid in them, can the shop charge a fee such as $1 for sampling per visit and then allow the customers to taste test using the provided equipment and liquid? Does there need to be a charge per sample? If there is a charge per sample, does that include just the liquid or also the vaporized used?"

It took them a month to respond by quoting the regs which don't actually answer what I'm asking, I guess we'll see how long it takes them to respond again, and if they actually provide any new information.

 

[Ed_C]

I imagine they might stop the sell of samples at some point, as it's not legal to sell individual cigarettes, if I'm not mistaken.

 

[Lessifer]

I imagine they might stop the sell of samples at some point, as it's not legal to sell individual cigarettes, if I'm not mistaken.

You're right, single cigarettes are not legal. I've read about cigar stores providing samples of cigars so that customers can decide if they want to purchase large quantities, but they obviously have to provide the whole cigar so that might be easier. I suppose a more direct comparison would be a pipe tobacconist providing a bowlful for their customer to sample, but I haven't been able to see if that is even done. Of course they're under the same regs now too, so they may not know either.

I'm upset that it appears that they didn't actually even read my question. I expect the twitter bot to provide canned answers, but when they take a month to reply to my email, it would be great if they actually answer the question.

 

[DC2]

I'm upset that it appears that they didn't actually even read my question. I expect the twitter bot to provide canned answers, but when they take a month to reply to my email, it would be great if they actually answer the question.

Ha ha. You so silly.

 

[Sanctuary Denied]

I don't know if I should even post this, but I went to a B&M and they said I could touch and smell the open bottle but could not sample it.
As person set the bottle on the table, turned his back to me, and walked away this person said "if I catch you trying to sample it you will get a warning. I can not stop you by making physical contact if you do. You only get one thousand warnings then I have to kick you out."
Luckily I didn't have to be kicked out.

 

[Ed_C]

I'm upset that it appears that they didn't actually even read my question. I expect the twitter bot to provide canned answers, but when they take a month to reply to my email, it would be great if they actually answer the question.

Actually, it looks like they summarized your question at the top of their response. Perhaps they didn't answer it because they have no answer.

 

[Ed_C]

Not everyone is on the same page about sampling. Anyone read this?
Charging to try flavors?