22 Sep FDA Compliance Update for Retail Tobacconists
Effective August 8, 2016, retailers are not permitted to distribute free samples to consumers at fundraisers, charity events, in-store events, legislative events, etc. IPCPR believes that the following practices do not violate the free sample provision, and have requested written confirmation from FDA:
- Providing a cigar in exchange for buying other products (e.g. “buy one get one free”).
- Replacing a plugged, spoiled, or otherwise damaged cigar for free.
- Having a raffle with cigar(s) as prizes if there is a cost to enter the raffle.
IPCPR’s Recommendation: A transaction must always take place, so keep a paper trail. IPCPR recommends exercising caution until we receive further explanation from FDA regarding the legality of specific practices and scenarios.
Effective August 8, 2016, retailers must verify by means of photographic identification that the customer is 18 years of age or over, and must card all patrons under the age of 27. Age verification practices apply in accordance with your state’s specific age requirements. On September 15, FDA announced it has taken action against 55 tobacco retailers by issuing the first warning letters for selling newly regulated tobacco products to minors. IPCPR is preparing updated age verification window appliques and signage, which will be mailed to you next month.
IPCPR’s Recommendation: Card all customers, even regulars.
Blending Pipe Tobacco
Retailers that plan to continue blending pipe tobacco after December 31, 2016, must:
- Register with FDA between August 8, 2016 and December 31, 2016. Registration forms and information about registering and listing electronically is available on FDA’s website. There is no registration fee.
- Submit ingredient lists to FDA by August 8, 2017 if you are a small scale tobacco manufacturer that has 150 or fewer full-time equivalent employees and $5 Million or less of revenue. Otherwise submit ingredient lists by February 8, 2017. Click here to view guidance document.
- Submit health documents on the effects from the pipe tobacco products to FDA by August 8, 2017 for small scale tobacco manufacturers. Otherwise submit health documents by February 8, 2017. Click here to view guidance document.
- If you register and list a tobacco product, you then need to determine whether that product is grandfathered commercially marketed on February 15, 2007, (see FDA guidance here http://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/ucm416495.htm), or whether you need to submit a substantial equivalence (SE) application (see FDA guidance here http://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/ucm253273.htm), or whether you need to submit a premarket tobacco product application (PMTA) (see draft FDA guidance here http://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM273425.pdf). The last day to submit an SE application to FDA is February 8, 2018, and the last day to submit a PMTA application to FDA is August 8, 2018.
Retailers that do not plan to register as a manufacturer with FDA should discontinue selling blended pipe tobacco by December 31, 2016. IPCPR believes that the following practice does not violate the pipe tobacco blending provision, and has requested written confirmation from FDA:
- Placing open bags of pipe tobacco, a scale, and smaller bags or containers in the store and putting up a “formula board” for the customers to buy the ingredients to make their own blends.
IPCPR is supportive of the Pipe Tobacco Council position: “…the Council does not believe that FDA should regulate the blending and apportioning of bulk pipe tobacco. Further, the Council believes that pipes are accessories to pipe tobacco and should not be subject to regulation under the final deeming rule.” Along with the Council, IPCPR is pursuing further clarification on pipe tobacco regulation from FDA.
IPCPR’s Recommendation: If a retailer plans to continue blending pipe tobacco, that business should register as a manufacturer with FDA.
Warning plans should be submitted to FDA no later than May 10, 2017. Warning plans are required for retailers that:
- Direct their own cigar advertising. A warning plan and/or warning labels are not required if retailer advertising only promotes a store location or name. IPCPR believes that the warning plan requirements are triggered by the mention of a specific tobacco product, not by the mention of a manufacturer. However, we have requested written clarification from FDA to confirm this position.
Warning labels are generally the manufacturer’s or importer’s responsibility. Click here to view the draft guidance document on The Submission of Warning Plans for Cigars.
IPCPR’s Recommendation: Retailers that plan to advertise specific tobacco products should submit a warning plan to FDA in advance of the deadline, as it is unclear how long the approval process will take.
Effective August 8, 2018, retailers of cigars sold individually and not in product packaging that contains the required warning label must post a warning sign that lists all six of the required warning statements at the point-of-sale. Cigar retailers are responsible for creating and posting these signs in accordance with the regulation. IPCPR will provide an FDA approved template point-of-sale sign for our members to display at a later date.
IPCPR’s Recommendation: All retailers should post the FDA approved point of sale sign.
International Premium Cigar and Pipe Retailers Disclaimer of Legal Liability
The materials and information set forth in this email are provided by the International Premium Cigar and Pipe Retailers (“IPCPR”) for informational purposes only and are to be used as a tool to help retailers navigate the recently issued Food and Drug Administration (“FDA”) regulations. IPCPR has taken reasonable efforts to ensure that all materials and information included herein are accurate and complete. However, as new information becomes available and as the FDA regulations are implemented, the recommendations set forth herein may change. For this reason, it is recommended that retailers evaluate the applicability of the information set forth herein in light of particular situations and current information. The review of this document is not a substitute for obtaining advice from qualified professionals. If legal or other professional advice is required, it is recommended that the reader obtain advice from qualified legal or other professionals.
The information presented in this document is provided “as is” without representation or warranty of any kind. In no event shall IPCPR, or its directors, officers, or employees, be held liable for any losses, injury, damages, or any other consequences resulting from, or arising in connection with, the use or reliance on this document, or any information or materials contained therein.