FDA Regulations: New Article Aug 2, 2016 by Tom Wolfe

Let's get Peck to represent us all in a class action.

Looks like my cellaring deep will pay off. Who knew, moi.
Now where is my Christmas Cheer?

I'm obviously missing something here.
I'm looking at the FDA's published document on rules governing tobacco product manufacturers and importers. on page 3 of their summary the FDA explicitly EXCLUDES "components and parts not made or derived from tobacco". On page 5 the FDA gives EXPLICIT examples of items EXCLUDED from regulation including "Pipe, mouthpieces, pipe bowls". So please explain to me, when the FDA EXPLICITLY EXCLUDES REGULATION of these items in its PUBLISHED GUIDELINES how any of this requires pipe carvers to provide 20 example of their work for FDA approval. Either I'm missing something, or somebody else did and error is becoming a "fact".
There are other parts of the article that don't exactly gibe with what I've read, but let's start with that one.

Paragraph 2 tells you why pipe smokers got broom-handled. Hopefully the deeming date will get moved to 2016 by the pending House Bill.

Great article.

Good article.

Unfortunately my favorite pipe makers are relatively new artisans who produce one-off pipes. They may be able to survive by creating artistic pipes as display-only pieces, or by under-the-radar commissions for their established clients, or perhaps "test smoking" & selling them as estate pipes.

That's a dry-eyed step-by-step walk through the deeming regulations as they are written and currently expected to be enforced. If the law suits delay and waylay the process, that may be a saving grace, but clearly that's not to be expected. The effect on pipe manufacture or hand crafting sounds especially ominous, not least for our friends and compatriots at Sparta, N.C., at the Dr. Grabow plant, and Washington, Missouri, at the Missouri Meerschaum plant. And at blending workshops throughout the U.S. and beyond (beyond as relates to importing, etc.). So maybe estate pipes (and all of the pipes on your rack) will be worth five times what you'd ask today, but that isn't much fun, nor solace. Most of us don't own 'em to sell 'em anyway. Thanks, Tom, good story, hard reality. Looking for a brighter day.

One other thought besides the questionable accuracy. Another off "fact", there is language in the Rule requiring foreign blends to be registered by December 31st. Imports aren't exempt as stated in the article.
Components aren't regulated. Sell a pipe and its stem separately as component parts. Assembly by purchaser.

To Sablebrush52
I originally read the FDA Deeming Rule as excluding pipes, but that is not the case. Page 4 of their reads as follows:
While FDA currently has authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco under chapter IX of the FD&C Act, under the final rule, all additional tobacco products that meet the statutory definition, except accessories of those newly deemed tobacco products, will be subject to chapter IX of the FD&C Act and its implementing regulations. These products include cigars, pipe tobacco, water pipe tobacco, electronic nicotine delivery systems (ENDS) (including e-cigarettes), and other novel tobacco products such as

certain dissolvable products and gels. These products further include components and parts of the newly deemed products, including pipes, e-liquids, atomizers, batteries, cartomizers (atomizer plus replaceable fluid-filled cartridge), tank systems, flavors for e-liquids, vials that contain e-liquids, programmable software, flavor enhancers for waterpipe tobacco, waterpipe cooling attachments, water filtration base additives,

flavored waterpipe tobacco charcoals, and waterpipe

bowls, valves, hoses, and heads.

regulatory impact analysis
See also the following link FDA Regulation of Pipe Tobacco It specifically states "This includes components and parts such as pipes, but excludes accessories such as lighters."
As to importers of tobacco blends needing to register by 12/31, the registration rule applies to Domestic manufacturers of tobacco products. Other parts of the rules do apply to importers, such as labeling and Premarket Tobacco Applications. "Every person who owns or operates any domestic establishment engaged in manufacturing regulated tobacco products must register. . ." Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments

A visual history of the United States.
240 years condensed to one minute:
https://www.youtube.com/watch?v=9I9k9rHB4EA

To jpmcwjr
As noted in my previous post, the FDA explicitly states that pipes are a tobacco product under their definition.

In 2016, FDA finalized a rule extending our regulatory authority to cover all tobacco products, including pipe tobacco. FDA now regulates the manufacture, import, packaging, labeling, advertising, promotion, sale, and distribution of pipe tobacco. This includes components and parts such as pipes, but excludes accessories such as lighters.

Click to expand...

Here is the link FDA Regulation of Pipe Tobacco
As to the 20 samples, it was first reported on Facebook and I had to dig around to confirm it. Here is the link where the FDA "recommends" that number of samples. This is part of their Premarket Tobacco Review process. See page 16 of the following document: Applications for Premarket Review of New Tobacco Products

I think artisan pipe makers will be able to get around this by simply referring to their pipes as sculptures, and works of art. They sell crack pipes, meth pipes, etc.. in Canada, which is drug paraphernalia technically, legally in stores, by calling it tobacco pipes. So I'm sure there'll be crafty ways of getting around this. It's not the artists fault that someone decides to use their sculpture as a pipe to smoke tobacco in.

This borders on communist state behavior. It won't be long and there will only be one blend of pipe tobacco available to the masses and it will be generally labled as "Party Blend Pipe Tobacco" or maybe "Regime Blend". It will probably taste like Borkhum Riff Original and bite your face off.

Accessories of newly-regulated tobacco products are not regulated

Click to expand...

See this is where there's room for creativity.

So these rules only apply to Domestic manufactures? Can a domestic manufacturer export the product to their Mexican (warehouse putting on a label) operations for import?

To Andy
I agree that accessories of the newly regulated tobacco products are not regulated. The problem is that pipes are defined as "components or parts" of pipe tobacco. It doesn't make sense, but that is why it is part of the lawsuit mentioned in the article.

In 2016, FDA finalized a rule extending our regulatory authority to cover all tobacco products, including pipe tobacco. FDA now regulates the manufacture, import, packaging, labeling, advertising, promotion, sale, and distribution of pipe tobacco. This includes components and parts such as pipes, but excludes accessories such as lighters.

Click to expand...

To leacha
Domestic manufacturers are subject to the rules, even if they produce tobacco only for the export market.
Importers do not currently need to register, but they do need to follow all of the other regulations regarding the products (pipe tobacco and pipes) that they import.