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papipeguy

papipeguy

Lifer
Jul 31, 2010
15,778
35
Bethlehem, Pa.
6 weeks ago I submitted a question to the FDA asking them to distinguish between samples and gifts. My thinking was that if a shop or any vendor "gifts" someone a bit of tobacco is it really a free sample. I realized that it is semantics but the two words do have different definitions. Anyway, here's the response from the FDA. It's pretty much what I expected but a lawyer should have a field day with this if push comes to shove.
Thank you for submitting a question to the U.S. Food and Drug Administration (FDA) during our May 25, 2016 webinar 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). Below, you will find information related to your submission and links to some related websites.
You asked about free samples 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.
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 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 to our website.
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
May 25, 2016 Webinar Question: Free Samples
Please distinguish between free sample and gift from the retailer.
IM1070277

 
A

aldecaker

Lifer
Feb 13, 2015
4,407
42
Oddly, it seems like an uncharacteristically clear answer. I thank you for taking the time to inquire about it, and posting the answer here. Every bit of info we can get helps.
It does continue to strike me how deeply entrenched these assholes are when it comes to propagandizing their dictatorial overreach, though. The "FAMILY" Smoking Prevention and Tobacco Control Act. Seriously? So, orphans, bachelors, and spinsters are off the hook? The government doesn't give a shit if they smoke? It's just silly. I'm truly more scared of the type of knee-jerk, warm-fuzzy loving imbeciles that are gulled by that horseshit than the amoral spin doctors who use it.

 
peckinpahhombre

peckinpahhombre

Lifer
Dec 24, 2012
7,195
456
I don't think it would take too long for a court to conclude that tobacco given by a retailer but called a gift is a free sample. A gift is a voluntary transfer of property with donative intent. Simply calling something a gift does not mean that it is a gift. The only reason a retailer would give tobacco as a "gift" is because they are expecting something in return in the form of promoting their business, which hopefully will ultimately lead to higher sales. A retailer can call it a gift if they want, but it is not that. Businesses operate for profit and they don't generally give their assets away unless they are expecting some ultimate benefit from doing so.
The more interesting question to me is whether the provision of a sample for, say, a bright shiny penny would constitute a free sample.
On the one hand, there is consideration being paid for the sample, so you can take the position that it is not "free".
On the other hand, if I was the FDA I would argue that the sale of any tobacco for a price that is below an arm's length price for such a sale (ie below what the retailer could otherwise reasonably receive for the tobacco in the market) does constitute a free sample to the extent that the amount paid by the patron is less than what the retailer could otherwise charge. It would not shock me if a judge, interpreting the language in the context of its legislative purpose, would agree with this interpretation. Or at least, it's not a hill that I would want to die on.

 
tmb152

tmb152

Can't Leave
Apr 26, 2016
392
5
Actually, I don't see where they ever really addressed the OP's question at all! I don't see the word gift anywhere in their diatribe. Frankly, it is none of the gov's business how a company conducts its affairs, and so long as the company is not selling or giving away to minors, I say: BUG OFF!
But one way around this is for companies to give out a "Rewards" card, for every dollar spent, you accrue points which have a dollar value which can be redeemed on a future purchase. The net effect is the same, you will eventually get a "gift" or a "free sample," but you will have earned it, and it might be one way of shoving the big fat bone up the damn fed's ass. Who in Congress came up with this bloody idea in the first place?

 
A

aldecaker

Lifer
Feb 13, 2015
4,407
42
@tmb- The answer makes it clear that the transfer of tobacco from a vendor to a customer must be for compensation. They state very clearly, "not for free". "Not for free" is the opposite of the definition of "gift", so there is the answer to the question, stated exceptionally clearly. It is not the answer we wanted, but it is a very clear answer.

 
A

aldecaker

Lifer
Feb 13, 2015
4,407
42
I'm not sure where anyone is seeing any wiggle room here. They are pretty clear on saying a vendor can't give away free tobacco. Period. You can call it a sample, a gift, or Frederick the Great if you want to, but if it's free, it's against the reg.

 
peckinpahhombre

peckinpahhombre

Lifer
Dec 24, 2012
7,195
456
But one way around this is for companies to give out a "Rewards" card
Click to expand...
I don't see anything wrong with a rewards card and see nothing in the FDA materials I saw that would prevent it. Also, the FDA has already stated that it would be ok if you have a sale such as "buy two cigars get one free". That is a discount available to all, and is effectively a sale where the retailer is functionally selling three cigars for the price of two, so the "free" cigar isn't really free at all.This begs the question then of whether it would be a problem if you have a sale where someone buys a tin and they get 1 oz of a tobacco for free. Seems to me that would not be a problem under the regs as long as the "sample" is tied to a sale.
The penny sample (without being tied to a real sale) is to me a bit grey because the consideration being paid (a penny) is trivial.

 
jndyer

jndyer

Lifer
Jul 1, 2012
1,020
725
Central Oregon
The only way I see this from what was posted was to charge a small fee for the tobacco sample.The good news is that at a pipe show you could bring or buy a smaller pipe and be charged a dime for each sample (which would not be far off from the actual price that a retailer would pay).

 
woodsroad

woodsroad

Lifer
Oct 10, 2013
11,798
16,168
SE PA USA
The other issue with samples is the size. Part of the deeming regs deals with new products, and the FDA considers a change in product weight or size to be a new product. New products must go through the FDA approval process. So unless a manufacturer was already selling sample-sized packages prior to the deeming regs enactment, I have to believe that they would be within the law to consider samples to be new products and requiring that they seek FDA approval through one of the three pathways.

 
peckinpahhombre

peckinpahhombre

Lifer
Dec 24, 2012
7,195
456
Great point Woodsroad.
So if you are giving samples (even if tied to a sale) the sample itself must adhere to FDA requirements. What a mess.

 
A

aldecaker

Lifer
Feb 13, 2015
4,407
42
@shotime and jndyer- a favorite tactic of the creeping incrementalist prohibition zealots was the "liquor by the drink" blue laws. I wouldn't be surprised to see some parallels to that with vaping or tobacco samples branded as "nicotine by the hit".

 
mso489

mso489

Lifer
Feb 21, 2013
41,210
60,459
I think many pipe show patrons would be glad to pay a modest but proportionate fee for a sample table, like three dollars for three, or five, samples. Still this runs headlong into local tobacco sales laws and taxes that might make it too much trouble for the blenders. How about a sampling table where participants, not exhibitors, would each bring a tin and lay them open so all could try any of it? It wouldn't serve the immediate interests of blender exhibitors, but it would permit sample tasting and generate interest in various blends.

 
dochudson

dochudson

Lifer
May 11, 2012
1,635
12
I dont get out much.. the only show I attend is the upcoming one in Columbus. Where are you guys getting enough free samples that not getting them would be a hardship?

 
mso489

mso489

Lifer
Feb 21, 2013
41,210
60,459
doc', I don't think it's a hardship question. Rather, part of the festive aspect of a pipe show, and part of the benefit of admission is/was a chance to try some various blends that you might like to buy. The actual sale of tobacco seems to have been discouraged at the most recent two pipe shows in my state, but I tasted samples at each of those that prompted me to go buy them online. So rather than hardship, it was part of the festivities and pipe culture. How about New Orleans Mardi Gras without the parade; well, it might be okay, but it would lack an important feature. Same with the samples at pipe shows. Same with samples at pipe shops, though there it is not festivity but a friendly, generous ambiance.

 
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