FDA Just how secure are trade secrets once in the hands of the FDA?

[Gato del Jugo]

From what I understand, the FDA is requiring all manufacturers -- including juice-makers, mind you -- to submit "a listing of all ingredients, including tobacco, substances, compounds, and additives that are, as of such date, added by the manufacturer to the tobacco,paper, filter, or other part of each tobacco product by brand and by quantity in each brand and subbrand"...

904(a)(1) and 904(c)(1)

Regulations.gov


Isn't this basically handing over exact e-liquid recipes?


And, "hypothetically speaking," of course.. How much is this information worth to, say, BT..?

 

[stevegmu]

Nothing. BT has chemists, consultants, research teams of their own. They don't want the publicity of a lawsuit from Halo, Johnson Creek, or the like...

 

[Gato del Jugo]

Nothing. BT has chemists, consultants, research teams of their own. They don't want the publicity of a lawsuit from Halo, Johnson Creek, or the like...

Lawsuits? What lawsuits..?


Nobody has to know about this...

*wink wink*

 

[edyle]

Is there anything unique about this to eliquids?

I mean is there anything new there that does not apply to food and/or drugs generally.

 

[stevegmu]

Why would they risk a leak, which generally happens when Washington is involved, when they can buy e-juice and discover the exact ingredients and ratios with a simple lab analysis?

 

[Gato del Jugo]

Why would they risk a leak, which generally happens when Washington is involved, when they can buy e-juice and discover the exact ingredients and ratios with a simple lab analysis?

Given all that we know about the FDA, you certainly place much trust in them..


You also appear to have much confidence in BT's scientists -- whose employers, mind you, for some odd reason still use lousy, nasty e-liquid in their cigalikes, while plenty of non-BT juice-makers have been putting out some tasty, delicious stuff for years now...

 

[stevegmu]

Given all that we know about the FDA, you certainly place much trust in them..


You also appear to have much confidence in BT's scientists -- whose employers, mind you, for some odd reason still use lousy, nasty e-liquid in their cigalikes, while plenty of non-BT juice-makers have been putting out some tasty, delicious stuff for years now...

I just know how the government works, and know that regular people work for the government, not mysterious men in black with agendas...
Cigalikes are the vast majority of the e-cig market, not re-fillables... Johnson Creek makes the juice for BLU, which I like from time to time-

 

[Gato del Jugo]

I just know how the government works, and know that regular people work for the government, not mysterious men in black with agendas...

In that case, somebody should have told these guys, for example, that they were just being silly & wasting their time by submitting a letter to the FDA like this...


"The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading research-based pharmaceutical and biotechnology companies, which are devoted to inventing medicines that allow patients to lead longer, happier, healthier and more productive lives. Investing over $26 billion annually in discovering and developing new medicines, PhRMA companies are leading the way in the search for cures.

PhRMA is pleased to submit these comments on FDA’s Guidance for Industry: Disclosing Information Provided to Advisory Committees in Connection with Open Advisory Committee Meetings Related to the Testing or Approval of New Drugs and Convened by the Center for Drug Evaluation and Research. PhRMA’s members routinely submit new drug applications to CDER and participate in advisory committee meetings relating to those applications.

In these comments, PhRMA explains that the FDA’s Draft Guidance does not adequately protect industry trade secrets and confidential commercial information. If adopted as currently drafted, the Draft Guidance will place the Food and Drug Administration (FDA) in violation of the Trade Secrets Act, 18 U.S.C. 5 1905, and it may have unintended and undesirable effects on the usefulness of the advisory committee process."

...

"The Draft Guidance does not adequately protect proprietary information belonging to new drug sponsors and it may actually have a detrimental impact on the advisory committee process. While PhRMA is in complete agreement with some of the materials that CDER identified as presumptively releasable or non-releasable, under the Draft Guidance, many items would be treated as presumptively releasable that are, in fact, confidential commercial information. PhRMA asserts that many of the items CDER has identified as presumptively releasable are exempt from disclosure under FOIA Exemption 4.

In addition, If FDA were to release any of these enumerated items, it would violate federal criminal law. The Trade Secrets Act, 18 U.S.C. § 1905, prohibits any federal employee from disclosing any “trade secrets, processes, operations, style of work, or apparatus.” Many of the items CDER has identified as presumptively releasable constitute trade secrets. To suggest - as the Draft Guidance does - that these items are not within Exemption 4 would significantly deviate from prior agency practice. Since 1974, FDA has treated the materials within an NDA as trade secrets or confidential commercial information, within Exemption 4 of the FOIA and protected from disclosure under the Trade Secrets Act. 39 Fed. Reg. 44602, 44633-44642 (December 24, 1974)."


http://www.fda.gov/ohrms/dockets/dailys/00/apr00/040500/c000003.pdf

 

[stevegmu]

All companies have attorneys who daft letters such like that to protect their interests, no matter how remote the chance of trade secrets being sold or released. I can't even take a picture at work...
If I were into DIY, I would just send off a sample of my favorite commercial juice to a lab to be analyzed...

 

[Gato del Jugo]

All companies have attorneys who daft letters such like that to protect their interests, no matter how remote the chance of trade secrets being sold or released. I can't even take a picture at work...
If I were into DIY, I would just send off a sample of my favorite commercial juice to a lab to be analyzed...

Again, if it's so cheap & easy to do, then why aren't all these juice-makers, large & small, simply doing what you suggest so they can make some good e-liquid for a change, too, and grab a larger market-share & make boatloads of money?

Also, I urge you to go check out the ECF DIY sub-forum.. Why, for all these years, are all these DIY'ers wasting their time & money by trying to recreate some of their favorite liquids, when according to you, they can simply send it off to a lab & get the exact recipe & processes for a few hundred bucks?

And why is there a 1.5-year-long thread consisting of 200 pages & countless DIY'ers (and it's not the only long thread on this subject) *still* trying to recreate Boba's Bounty, which has been out for like 5 years now..?

http://www.e-cigarette-forum.com/forum/diy-e-liquid/353176-my-bobas-clone.html


Makes zero sense -- unless, of course, you actually think e-liquid reverse engineering is a really easy thing to do.. which, judging by all of the above, apparently it is NOT...


Bottom line is, for the past 15 years or so, partly thanks to the proliferation of computers & the internet & electronic communication/information tools, certain industries including pharmaceutical companies, biotech companies & medical device companies have been making a big stink over the FDA who has been, accidently or not, leaking all sorts of data, including trade secrets. It even got to the point where Congress had to step in & publicly slap the FDA on the wrist..

In addition, during this time the FDA has also been trying to change the way they do their job, which would open more information to more people (including a company's competitors -- hmm, I wonder why they'd want to do that?).. which is why individual companies & industry trade groups have been making a stink over this, too...


Anyway, the proposal is saying that FDA wants the exact recipes for all e-liquids.. This includes the exact formulation, the exact ingredients, the exact percentages, and the exact brands of each of those ingredients...

If you honestly don't believe that BT is in bed with the FDA, which many across the vaping community believe they are, then this wouldn't make sense.. But again, how much is all this e-liquid information worth to BT? What could they do with this information? Imagine having the exact recipes & processes to all the flavors of all the popular juice-makers out there, at your fingertips...


And sorry, but I've had a bunch of various BT cigalike flavors before, including your blu Menthol.. They're disgusting...


EDIT: Wrong blu flavor.. but still disgusting..

 

[stevegmu]

People are cheap, and don't want to put out money for lab fees...

No, I don't believe BT is the boogeyman. I also don't think they have anywhere near the power they once had.

 

[tombaker]

From what I understand, the FDA is requiring all manufacturers -- including juice-makers, mind you -- to submit "a listing of all ingredients, including tobacco, substances, compounds, and additives that are, as of such date, added by the manufacturer to the tobacco,paper, filter, or other part of each tobacco product by brand and by quantity in each brand and subbrand"...

904(a)(1) and 904(c)(1)

Regulations.gov


Isn't this basically handing over exact e-liquid recipes?


And, "hypothetically speaking," of course.. How much is this information worth to, say, BT..?

You are mistaking ingredient listings with a Recipe, which is a far different thing.

You should consider it much like a cook, and how they make something, same ingredients, much different results.
A recipe is a description of a procedure, one of the things are the ingredients.
Onions, vs Carmalized onions.
Or as way of another example, reference Breaking Bad