FDA Regulations In Place, Land of the Free No More!

This morning as cigar shops open around the United States of America new FDA Regulations are in place. While many are calling this the end of an industry that might be premature as lawsuits are in place and new releases should still find their way to the shelves prior to 2018 as many companies have released cigars to the market prior to today that should see full releases in the near future.

However, some things will change and the following comes from IPCPR:

Prohibition on Free Samples
“FDA wishes to clarify that allowing prospective adult buyers to smell or handle a cigar is not considered the distribution of a “free sample” as long as the product is not actually consumed in the retail facility and the prospective buyer does not leave the facility with a free tobacco product (whole or part). . . . However, if the prospective buyer lights and draws or puffs on the cigar to keep the cigar lit, or otherwise uses the free cigar or leaves the retail establishment with a free cigar, this would constitute a “free sample” in violation of” FDA regulation.

Manufacturers are Required to Register and List ProductsAccording to the final rule, “retail establishments that blend pipe tobacco, are subject to and must comply with all applicable statutory and regulatory requirements for tobacco product manufacturers” (see below).

Minimum Age and Identification Requirements
Must not sell to any person younger than 18 years of age;
Must verify by means of photographic identification containing the bearer’s date of birth that the person is 18 or over;
No such verification is required for any person over the age of 26; and
Can not sell cigars with the assistance of any electronic or mechanical device (such as a vending machine), except in facilities where the retailer ensures that no person younger than 18 years of age is present, or permitted to enter, at any time.
Note: A tobacco product “accessory” (e.g., humidors, lighters, cutters, ashtrays) is not regulated as a tobacco product.  “Components” and “parts” of a tobacco product are deemed subject to regulation (e.g., pipes, flavors, tobacco pouches).

Can not say or imply in labeling or advertising that a product has a lower risk of disease, is less harmful, or that it contains a reduced level or is free from any substance.

Enforcement action against products determined to be adulterated or misbranded

If you fail to take any required action listed here or in future regulations, or if FDA determines that the products are contaminated by an added substance that may cause injury, then FDA can deem the products “adulterated” or “misbranded” under the law.  That determination permits FDA to take enforcement action (e.g., Warning Letters, product seizure, injunction, fines).

MANUFACTURERS AND IMPORTERS – REGULATORY COMPLIANCE TIMELINE

AUGUST 8, 2016
First day for domestic manufacturers to register and list products. Registration is required by December 31, 2016. Foreign manufacturers will be required to register and list too, but this will require a separate registration with its own effective date.

Can not say or imply in labeling or advertising that a product has a lower risk of disease, is less harmful, or that it contains a reduced level or is free from any substance.

Prohibition on free samples.
Premarket review requirements (SE, SE exempt, and PMTA) apply to all products not on the market as of August 8, 2016 unless “grandfathered.”  For products marketed before August 8, 2016 but not “grandfathered,” enforcement is delayed if submitted and/or under review by certain dates (see “Premarket Review Compliance Periods” below).

Notify FDA if adding a new additive or increasing the quantity of an existing additive 90 days before making such change.

Enforcement action against products determined to be adulterated or misbranded

If you fail to take any required action listed here or in future regulations, or if FDA determines that the products are contaminated by an added substance that may cause injury, then FDA can deem the products “adulterated” or “misbranded” under the law.  That determination permits FDA to take enforcement action (e.g., Warning Letters, product seizure, injunction, fines).

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