FREQUENTLY ASKED QUESTIONS About the 2016 FDA E Cig & E-Liquid Regulations
What do the new regulations do?
The FDA will now regulate all tobacco products including e-cigarettes, cigars, hookah tobacco and pipe tobacco. The agency already oversees cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco products. The rule bans sale of all types of tobacco products to people younger than 18, requires photo identification for buyers younger than 26, prohibits sales in vending machines (except those in an adult-only facility) and prohibits the distribution of free samples. The rule also requires that all products carry warnings that they have nicotine, an addictive chemical. Virtually all e-cigarettes and any new tobacco products will have to seek marketing authorization from the FDA[i].
Are any products approved by the FDA?
No e-cigs or e-liquid products have been “approved” by the FDA. That is what the new regulatory process will ultimately achieve over the next two to three years. All products on the market prior to August 8, 2016 would be considered lawfully in commerce, unless there are other violations. As required under the new regulations, all manufacturers of other e-cigs, e-liquids, mods, vaping devices and related products will need to prepare all of the documentation and required filings for submission to the FDA (known as a Pre Market Tobacco Application or “PMTA”)[ii].
What is the PMTA?
This is the vehicle by which virtually all e-cig and e-liquid product manufacturers will seek approval by the FDA. All PMTA applications must be filed before August 8, 2018. The applications will require substantial documentation, evidence, and data.
Are there any marketing restrictions like with cigarettes?
There are no marketing restrictions under the new regulations except for marketing to minors. However, within the next two (2) years, all advertisements must have the required health warning statement by May 10, 2018.
Can we give out free samples?
No. As of August 8, 2016, the new FDA regulations prohibit giving out free samples of product. However, many manufacturers are simply charging a nominal fee of one penny or one dollar for samples.
What about “sampling”?
A free “sample” is still considered free product by the FDA. However, if there is some consideration or payment (like 25 or 50 cents), then that would be a sale and not a free sample.
Is Child Resistant Packaging required?
Yes, as of July 26, 2016 the FDA requires Child Resistant packaging.
Do Manufacturers now have to “register” with the FDA?
Yes. All manufacturers, distributor, retailers are now required to register with the FDA by December 31, 2016. Prior to the new regulations, there was no “registration” process.
What about new flavors or products?
As of August 8, 2016, no new flavors or products may be introduced into the U.S. market without a PMTA. That’s the bad news. The good news is that, during the summer of 2016, Space Jam released 16 new flavors and 3 new Space Jam mods!
Do we need a listing of ingredients of each product?
Not at the present time. As part of the new regulations, however, a listing of ingredients will be required of every manufacturer for all products on the market as of August 8, 2016. The ingredient listings shall be submitted to the FDA by February 8, 2017[iii].
Will the FDA ban flavors?
FDA has considered and rejected a ban on flavors[iv].
Are there required warnings to be compliant?
Yes, there are required warnings that must read: “WARNING: This product contains nicotine. Nicotine is an addictive chemical.” All products and advertising must contain this warning by May 10, 2018. [v].
Why did the FDA institute the new regulations?
The FDA believes “this action a milestone in consumer protection” as they will now be able to review new tobacco products before they hit the market using PMTA’s as well as help prevent claims by manufacturers, which may or may not have been misleading. The FDA claims the regulations will help to evaluate the individual ingredients being used in the newly regulated products, primarily e-liquid. Finally, the FDA’s hopes to better communicate the potential risks of tobacco products to prospective and current consumers while combatting underage use of these products at the same time.
Why are there lawsuits against the FDA?
There are many lawsuits that have been filed against the FDA[vi]. The outcome of any of these cases is unknown. The claims in the lawsuits include 1st Amendment claims, claims that the FDA exceeded its authority and claims the regulations violate the Administrative Procedures Act.
Do I (the retailer) have to do anything?
The new regulations do have some provisions that would impact retailers. However, you are probably already complying. The main provisions are: no sales to minors and no free samples. For a complete legal analysis of issues unique to retailers, visit the FDA website or consult your legal counsel.
Who can I call/contact if I have questions?
For immediate help, call the e-cig and e-liquid team at Brown & Charbonneau, LLP at 714.505.3000 or email email@example.com
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FDA Regulatory Guidance
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Retailer Overview Information from the FDA
[i] How may a manufacturer legally begin marketing a new tobacco product in the United States? There are three pathways by which a manufacturer may legally market a new tobacco product in the United States: 1) Submit to FDA a (PMTA) under Section 910 (b) and obtain a written order permitting marketing of the new tobacco product; OR 2) Submit a Substantial Equivalence Report to FDA and obtain an order finding the product to be substantially equivalent to a predicate tobacco product (Section 905(j)(1)(A)(i)) and in compliance with the requirements of the Act; OR 3) Submit to FDA a request for an exemption from the substantial equivalence requirements, obtain an exemption (Section 905(j)(3), 21 CFR 1107.1), and then submit a report as described in Section 905(j)(1)(A)(ii)of the FD&C Act at least 90 days before commercially marketing your product.
[ii] What Information Is Needed in My Premarket Tobacco Application? Premarket Tobacco Application must include, as required by Section 910(b)(1) of the FD&C Act:
- Full reports of all information, published or known to, or which should reasonably be known to, the applicant, concerning investigations which have been made to show the health risks of such tobacco product and whether such tobacco product presents less risk than other tobacco products;
- A full statement of the tobacco product’s: components, ingredients, additives, properties, principle(s) of operation
- A full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and, when relevant, packing and installation of, such tobacco product;
- An identifying reference to any tobacco product standard, under section 907, which would be applicable to any aspect of such tobacco product, and either adequate information to show that such aspect of such tobacco product fully meets such tobacco product standard or adequate information to justify any deviation from such standard;
- Such samples of such tobacco product and of components thereof as the Secretary may reasonably require;
- Specimens of the labeling proposed to be used for such tobacco product; and such other information relevant to the subject matter of the application as the Secretary may require.
[iii] FDCA §§ 904(a)(1), (c)(1). See 81 Fed. Reg. 29006 (May 10, 2016); Compliance Dates at 10.
[iv] FDA has considered and rejected a ban on flavors in ENDS (See Final Deeming Rule, Advanced Publication, pages 140142, 152155, 307). If FDA were to issue a regulation banning flavors, the normal notice and comment process of proposed and final rules would be required and would take a number of years.
[vi] Right to Be Smoke-Free Coalition, et al v. Food and Drug Administration, et al (Case No. 1:16-cv-01210); Nicopure Labs LLC v. FDA, Case No. 1:16-cv-878 (challenging definition of “tobacco product” and pre-market authorization process); Lost Art Liquids, LLC v. FDA, Case No. 2:16-cv-3468 (cost/benefit analysis supporting Deeming Rule is not adequate and restraints on commercial speech); John Middleton Co. LLC v. FDA, Case No. 16-cv-996 (subsidiary of Altria Group Inc. wants to stop the FDA from banning its “Black & Mild” brand name for cigars and pipe tobacco because mild is in the name); Enrique Fernando Sanchez Icaza and Global Premium Cigars LLC v. FDA, Case No. 1:16-cv-21967 (Miami cigar maker wants to prevent the FDA from requiring labels that could comprise up to 30 percent of its cigar box and objects to how the FDA rules affect trademarked and copyrighted artwork); Larry W. Faircloth v. FDA, Case No. 2:16-cv-5267 (user of e-cigarette devices challenges “tobacco product” definition, states FDA regulations will drive up costs for consumers and consumers will be unable to receive truthful and non-misleading statements regarding products).
#deemingregs, #pmta, #fda