Need easy answers from smart forum members

[chellie]

Been vaping for over 3 years. Thanks to this forum - I have learned a lot and love to vape. For me, It got me off of a nearly 40 year analog habit.

I have made it a point to purchase from vendors that post their lab results. My concern is diacetyl because I mainly use vanilla flavors. When I first started vaping, I purchased my e-liquid at Johnson Creek and quickly stopped because they did not disclose their ingredients and have been buying from folks that are part of AEMSA or post a link to their lab results.

Wrote to Johnson Creek awhile back and they actually had a link to lab results for one of their eliquids. Just checked now and here is their answer to this question

Do any of your products contain diacetyl or acetyl propionyl?
The FDA regulations that went into effect on August 8, 2016 prevents us from answering this question. Our products are manufactured in compliance with the FDA regulations.

full answer at Do any of your products contain diacetyl or acetyl propionyl?

My Questions?

- Is it true that e-liquid manufacturers can no longer answer this question? Seems odd that someone cannot tell me what is in their product?
- Can manufacturers still post links for lab results?
- How can I make sure that I know what is in the products I purchase in light of the new regulations?
- Is there any documentation that explains all the new rules in easy-to-understand language?

Thank-you,

 

[chellie]

Note: I did find this on Reddit but it is over a year old. Vanda was one of the flavors I liked and it looks like it does indeed have it.

https://d1fardvzz27152.cloudfront.net/skin/frontend/jcosj/beta2/DAPA Certificates/ALL-JC_LabResults_2015Collection.pdf

 

[endlessendres]

Two things that I hope help you out:

First, any e-liquid that makes it through August 8th, 2018 date will not contain DAPA, as it is a requirement of PMTA approval.

Second, from my understanding companies can provide lab certificates that show results. But... the company cannot make any claims about those chemicals, as those claims could be construed as a Modified Risk Claim.

 

[Kurt]

Two things that I hope help you out:

First, any e-liquid that makes it through August 8th, 2018 date will not contain DAPA, as it is a requirement of PMTA approval.

Second, from my understanding companies can provide lab certificates that show results. But... the company cannot make any claims about those chemicals, as those claims could be construed as a Modified Risk Claim.

This is my understanding too. There are many companies displaying test results. The problem is that if the company had diketones in their e-liquids on Aug 8, then they cannot remove them from formulations, since this would create a new tobacco product. But I don't think there is anything in the regulations that prohibits disclosure of e-liquid components, as long as health claims are not made about these components, or the lack there of.

 

[LaraC]

The problem is that if the company had diketones in their e-liquids on Aug 8, then they cannot remove them from formulations, since this would create a new tobacco product.

A random thought... if a company that did have diketones in their e-liquids on August 8, decided to remove the diketones from their formulation AFTER that date, and then did this:

Gave a bottle of the new diketone-free e-liquid to a vendor who was willing to put it on his shelf and offer it for sale, say during October 2016, AND was willing to say he (the vendor) had received that bottle from the manufacturer (who also was willing to say the same thing) on August 7, 2016...

Illegal, sure.

Not anywhere near as "wrong", however, as what the FDA is doing with their ill-conceived war against electronic cigarettes.

 

[Kurt]

Yes, I think this is fine. As far as I know, as long as a product was on the market (and can be shown to have been for sale) before Aug 8, then it can be sold after Aug 8. So if Vendor X wants to sell diketone-free e-liquids manufactured and sold by Vendor Y, and they were sold before Aug 8 by Vendor Y, this is ok. I think the e-liquid cannot be rebranded, however, as in a new Vendor X label. But Vendor X cannot change any of their Vendor X formulations after Aug 8. This is similar to a vendor selling some hardware that was on the market before Aug 8, even if these new products are still trickling into the main-stream market, as long as SOMEONE was selling them before Aug 8. Similar to the e-liquid example because few in the US are manufacturing their own hardware. Any new gear we see popping up on websites supposedly was on the market before Aug 8, such as through directly buying from Joyetech or Kanger, which is often possible before most vendors have them in stock.

 

[retired1]

A random thought... if a company that did have diketones in their e-liquids on August 8, decided to remove the diketones from their formulation AFTER that date, and then did this:

Gave a bottle of the new diketone-free e-liquid to a vendor who was willing to put it on his shelf and offer it for sale, say during October 2016, AND was willing to say he (the vendor) had received that bottle from the manufacturer (who also was willing to say the same thing) on August 7, 2016...

Illegal, sure.

Not anywhere near as "wrong", however, as what the FDA is doing with their ill-conceived war against electronic cigarettes.

Only one problem with this whole scenario.

In order to maintain good manufacturing practices, you tend to document like crazy during the formulation and packaging process, including the date the product was mixed, when it's bottled, and when it's packaged for shipment/delivery. You would have to falsify a LOT of documentation in order to get away with something like this and if you're caught doing it, the results are not pretty.

Now, let's say you have a product that causes an issue, and you need to go back to your records to see if there's an issue with the entire lot. This could prove problematic if you've falsified your records as now you won't be entirely sure what's going on with your product.

And for those companies that rely on formulation and filling by 3rd parties, there's no way you're going to get them to falsify their records. And if you falsify yours to attempt an end run around the August 8th deadline, and it's compared to the records at the 3rd party formulation/filling company, you're now facing something bigger than if you had just left well enough alone. If you think the FDA is harsh now, watch what happens to a company when they're caught falsifying records. At that point, if the company is already on thin profit margins, you're going to see one less vape shop doing business.

 

[randyith]

interesting

 

[chellie]

I have found that some of the companies I have dealt with in the past have used the new rulings to their advantage, in my opinion, to mislead consumers. I mentioned Johnson Creek who I no longer patronize ----really irritated me to have them state that the new laws prevented them from doing certain things which is just not true. I had also purchased every now and then from Mt Baker. I had not purchased from the for some time and made an order after the laws changed. I noticed they did not have the larger size bottles and wrote ot them. They responsed that the new law prevented them from using the large sizes. That is just not true. They did receive quite a bit of negative publicity about this and kept coming up with new and improved reasons. I would have preferred the truth which was along the lines of them deciding to take to repackage their formulas at approximately the same and thus increase prices. If they would have been honest I would have made a purchase becaue things do change. When I receive a BS answer or I tink a company is talking down to me like I am a ....., I scratch them off my list asnd move on.

As much as I do not like the US Gov now "regulating" the industry which is my opinion is simply because of $$'s. really glad I am not in the UK. CHeck this out,

How strict new e-cig laws coming into force next month will affect you

 

[endlessendres]

I have found that some of the companies I have dealt with in the past have used the new rulings to their advantage, in my opinion, to mislead consumers. I mentioned Johnson Creek who I no longer patronize ----really irritated me to have them state that the new laws prevented them from doing certain things which is just not true.

Looking back at your post on JC, I'm still not sure why you feel their comments were false. You asked if a specific product contained DAPA and although they stated they couldn't tell you due to regulations (which is true, as it would be considered a modified risk claim), they still showed you by providing test results. What did they do wrong?

 

[zoiDman]

...

Do any of your products contain diacetyl or acetyl propionyl?
The FDA regulations that went into effect on August 8, 2016 prevents us from answering this question. Our products are manufactured in compliance with the FDA regulations.

full answer at Do any of your products contain diacetyl or acetyl propionyl?

My Questions?

- Is it true that e-liquid manufacturers can no longer answer this question? Seems odd that someone cannot tell me what is in their product?
- Can manufacturers still post links for lab results?
- How can I make sure that I know what is in the products I purchase in light of the new regulations?
- Is there any documentation that explains all the new rules in easy-to-understand language?

Thank-you,

The disclosure of DA and or AP in an e-Liquid is somewhat of a Grey Area.

Some are arguing (FDA, Anti e-Cigarette Groups) that by saying that an e-Liquid is DA or AP Free is making an "Implied Modified Risk Claim". And can not be done so without having been issued a MRTP Order.

And use this as a Legal Justification...

Special Rule for Certain Products

1. In General. The Secretary may issue an order that a tobacco product may be introduced or delivered for introduction into interstate commerce, pursuant to an application under this section, with respect to a tobacco product that may not be commercially marketed under paragraph (1) if the Secretary makes the findings required under this paragraph and determines that the applicant has demonstrated that
   1. such order would be appropriate to promote the public health;
   2. any aspect of the label, labeling, and advertising for such product that would cause the tobacco product to be a modified risk tobacco product under subsection (b) is limited to an explicit or implicit representation that such tobacco product or its smoke does not contain or is free of a substance or contains a reduced level of a substance, or presents a reduced exposure to a substance in tobacco smoke;

Section 911 of the Federal Food, Drug, and Cosmetic Act - Modified Risk Tobacco Products

I think much of the FDA's current Interpretation and Implementation will have to go thru the Court System for there to be a Definitive answer as to what a Retailer/OEM can and can not say about their products.

And it is Also another example of why e-Cigarettes do work well in the One-Size-Fits-All, Combustible Tobacco scheme that the previous FDA(s) used.

Because Many/Most are Arguing that ALL e-Cigarettes are Modified Risk if compared to Combustible Tobacco Products. So they Shouldn't be held to a Risk Standard to those Products.

So can a Retailer/OEM say if there is DA or AP in their e-Liquids? I'm not sure why a Retailer/OEM would want to do this before a Court Ruled one way or another if this was actually making an Implied Modified Risk statement?

 

[zoiDman]

BTW - If e-Liquids are currently being sold, and if DA or AP are viewed as having Potential Risk, how does Restricting the Disclosure of DA or AP Free e-Liquids promote Public Health on the Population Level?

Or enhance a Consumer's Ability to make an Informed Choice?