Monday, July 25, 2016

FDA's Convoluted Response to a Simple Question Shows How Arbitrary, Capricious, and Inane the Deeming Regulations Are

Someone shared with me the actual reply they received from the FDA in response to a very simple question:

"Are e-cigs that do not contain nicotine (or any other tobacco extracts) also covered by the FDA deeming regulations?  If so, will they also require pre-market approval like products that do contain nicotine?"

This seems like a simple and straightforward question that could and should be able to be answered with a simple "yes" or "no." After all, if e-cigarettes do not contain nicotine then there is no basis for the FDA to assert jurisdiction over them as tobacco products. Therefore, these nicotine-free e-liquids would not be subject to the pre-market approval requirements.

A simple answer of "no" would have and should have sufficed.

The Rest of the Story

Instead, here is the FDA's actual response:

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).  The information contained in this message is what is provided to vape shops to assist them with any questions about compliance.  We hope that you find this helpful.

FDA anticipates that newly regulated businesses may have many questions and compiled this e-mail as a resource to help you better understand the Deeming rule and the potential impact to your business.  We encourage you to review this information and keep checking our website for new information such as compliance training webinars and updates based on questions FDA receives.

It may be useful for you to know that the Deeming rule published in the Federal Register on May 10, 2016, and takes effect on August 8, 2016.  While FDA continues to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco products, the Deeming rule extends FDA’s authority to “newly deemed” tobacco products such as electronic cigarettes, cigars, hookah, and pipe tobacco, as well as their components and parts, but not the accessories of newly deemed products. The Deeming rule also includes additional restrictions for “covered tobacco products.”  A “covered tobacco product” is any newly deemed tobacco product, but excludes any component or part that is not made or derived from tobacco.

The law defines a manufacturer as anyone who manufactures, fabricates, assembles, labels, or processes a tobacco product.  Establishments, such as vape shops, that mix and/or prepare combinations of liquid nicotine, flavors, and/or other liquids, or an establishment that creates or modifies an aerosolizing apparatus for sale to consumers would be considered a tobacco product manufacturer. 

The rule will subject all manufacturers, importers and/or retailers of newly-regulated tobacco products to any applicable provisions, bringing them in line with other tobacco products the FDA has regulated since 2009.  

These requirements include:
  • Register domestic manufacturing establishment(s) and submit product listings to FDA by December 31, 2016;
  • Reporting ingredients, and harmful and potentially harmful constituents;
  • Requiring premarket review and authorization of new tobacco products by the FDA;
  • Placing health warnings on product packages and advertisements; and
  • Not selling modified risk tobacco products (including those described as “light,” “low,” or “mild”) unless authorized by the FDA.
Manufacturers of newly-regulated products must show that the products meet the applicable public health standard set forth in the law and receive authorization from the FDA, unless the product was on the market as of Feb. 15, 2007. The review process gives the agency the ability to evaluate important factors such as ingredients, product design and health risks, as well as their appeal to youth and non-users.

For products that were not on the market as of the effective date, a premarket authorization is required prior to marketing those products.  For products on the market as of the effective date, under staggered timelines, the FDA does not intend to enforce the premarket review requirements for up to three years while manufacturers submit – and the FDA reviews – a new tobacco product application. The FDA will issue an order granting marketing authorization where appropriate; otherwise the product will be subject to enforcement.

FDA does not assess fees associated with the requirements identified above. The costs associated with compliance with these requirements may vary based on the type and complexity of the product, and, as a result, FDA is not able to provide an individualized estimate of costs that you may incur. However, FDA has included in the preamble to the Deeming rule its estimates of the quantified costs associated with the Rule over 20 years, as well as estimated hourly burdens on impacted entities (such as tobacco product manufacturers) for the requirements described above. Please see the links provided below for more information.

As it relates to e-liquids that contain zero nicotine, generally, if your zero-nicotine product is not made or derived from tobacco, it may still be a tobacco product subject to FDA regulation if it is intended or reasonably expected to be used with or for the human consumption of a tobacco product; or intended or reasonably expected to alter the performance, composition, constituents, or characteristics of a tobacco product (with certain exceptions relating to controlling moisture or temperature for storage and initiating external heat source), your product is subject to FDA regulation.  These products will be evaluated on a case-by-case basis.  This applies to closed and open system devices that contain zero-nicotine.

As a tobacco product, your product will automatically be subject to all of the requirements in Chapter IX of the Federal Food, Drug, and Cosmetics Act and its implementing regulations relating to tobacco products when the deeming rule becomes effective on August 8, 2016.  However, for many provisions FDA is providing a compliance period with additional time during which FDA does not intend to enforce compliance with the requirements, as stated in the final rulemaking document.

In addition, if you’re solely a supplier and your zero-nicotine product is sold only to another company for further manufacture into a finished tobacco product, at this time, FDA does not intend to enforce certain automatic provisions of the law with respect to your product.  Therefore, for example, FDA does not intend to enforce the requirement that you register your manufacturing establishment and list your products, submit premarket applications, or submit ingredient listings or health documents.

There are additional requirements in the rule, such as minimum age, identification, and vending machine restrictions and health warning requirements that apply only to “covered tobacco products,” which does not include a component or part that is not made or derived from tobacco.  Accordingly, if your product is not made or derived from tobacco, it is not subject to such requirements.  Even if your product is not a covered tobacco product, however, FDA regulations prohibit you from distributing free samples of your newly-regulated product, including its components and parts, to anyone.
Regarding your fourth question, if the product does not contain nicotine and you have submitted a statement to FDA certifying so, according to the regulatory requirement, then you would not have to include the mandatory warning regarding the contents of nicotine in the product.
For More Information
To assist the newly-regulated tobacco industry in complying with the requirements, 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
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 plan to soon add a chart that may help you determine which provisions apply to you and the timeframes for complying.  In addition, FDA plans to post 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:

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

What Does This All Mean?

Despite having 11 years of post-secondary school education and a great deal of experience reading and interpreting legislation and regulations, I have no clue what the heck the FDA is talking about. I can't even imagine a scenario where a nicotine-free e-liquid would be incorporated into a "tobacco product," but if it were, it would only be a tobacco product if it was mixed with nicotine-containing e-liquid, in which case the manufacturer or retailer is not selling a nicotine-free e-liquid. Of course that would be considered a tobacco product.

The question here was much simpler. If I produce a finished e-liquid that is nicotine-free, is my product regulated and if so, do I have to submit a pre-market application? The answer appears to be no. But the FDA hides this answer in such a stream of incomprehensible jibberish that the poor small business owner (or even the large business owner) is more confused after having asked the question than they were before.

The time and resources necessary to even understand what is regulated and what is not regulated are prohibiting for most small business owners in the vaping market. And that's before even getting to the issue of what would be required in a pre-market application if the product is regulated.

This is quite obviously a nonsensical and non-workable regulatory approach and for that reason alone, it is not going to protect the public's health. Quite the opposite, it will harm the public's health by decimating the e-cigarette market, forcing thousands of owners of small entities out of business, and protecting real cigarettes from competition, thus increasing smoking-related disease and death.

In my opinion, this response from the FDA could be used by the plaintiffs in litigation against the agency in order to demonstrate the arbitrariness and capriciousness of the regulations, as well as their undue complexity and burden on small business owners.

So in response to the FDA's expressed hope to the inquiring business owner that "We hope that you find this helpful," I say: "Yes. Very helpful indeed."

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