Tag Archives: FDA

I’m going to lead off with this great article Dan Colley wrote with some of his insight into the new regulations from his time working for the FDA. This covers the importation procedures, I’m hoping he offers more thoughts on the implementation of the regulations at a later date.

 

Many of you are likely familiar with my name. I am Dan Colley and have been a reader of and commenter to the CigarCraig blog for quite some time. What you may not know is that I am a retired Investigator and Compliance Officer for the Food and Drug Administration (FDA). I left the Agency in the mid-1990s for work in the private sector. I have been retired now for about fifteen years I’ve been a cigar smoker since about 1967.

 

As someone who worked daily with the many requirements of the FDA, I have become intimately familiar with the import requirements that the law has put into place for many regulated products, from foods and drugs to medical devices, cosmetics and even tobacco products. The recent regulations that FDA has been charged with enforcing contain requirements that are new to the tobacco industry and I would like to provide you with some information about how those requirements will impact you, the cigars that you love to smoke and the tobacco industry in general.

 

It is important to know that the FDA and the U.S. Customs Service (Customs) work very closely together to enforce the various laws that regulate imports. Customs was first mainly interested in the collection of import tariffs, but as time has passed, they have joined their efforts with other Federal agencies who have authority over imported products. For example, the FDA has authority over foods, human drugs, animal drugs, cosmetics, medical devices, and tobacco that extend beyond taxes and tariffs. The procedures for allowing these products into the U.S. legally are essentially the same with very few differences.

 

I would like to briefly explain the physical process that imported products go through before entry into the U.S. The first thing that must occur when a foreign manufacturer wishes to import cigars into this country is that they make a declaration to the FDA and to Customs that a shipment is heading for the U.S. That declaration will usually tell those agencies what the shipment consists of, how it is arriving, where it will be offered for entry into the US and who the involved parties are. Typically, foreign manufacturers will use companies that consolidate shipments for ease and economy of transportation. When these freight consolidators are involved, they will make the required notifications to the U.S. agencies.

 

When the shipment arrives in the U.S., it is moved directly to what is called a bonded warehouse where it is held for government inspection. The consignee does not have access to the shipment at this point. Once the agencies are notified, policy dictates which path the shipment will follow.

 

There are several paths that are possible for these shipments to take. For example, some are merely “rubber-stamped” and allowed to proceed to the consignee without any action. This occurs when the agency has a long and successful relationship with the product and the manufacturer and has every reason to believe that the products comply with all requirements. That assumption is always based on historical data and not merely presumption.

 

Another path that imported products may follow is that of a simple examination. In cases like this, an inspector will go to the bonded warehouse and physically examine the shipment to see if it is what it is supposed to be and in the case of perishable items, the shipment is in good shape and not visually contaminated or adulterated. If no problems are identified, the inspector will file his paperwork with the FDA and the products is then released and may proceed to the consignee.

 

Since cigars do not meet the classic definition of “perishable goods”, they are primarily involved with what inspectors call a “paper chase”. Cigars require pre-market approval unless they were manufactured before the date that governing regulations were put into place, so it is not usually necessary to examine them for adulteration unless there is obvious physical damage to the shipment (eg: water damage, crushing, etc.). All the agency must do is verify that the cigars are either approved for sale in the U.S. or are ones that are “grandfathered” as being manufactured before the regulations became law. This is principally a paper exercise. FDA will review filings made by the manufacturer and will also examined specimens of the labels on the product to assure that they meet the requirements of the regulations. If they do, FDA releases the products. If they don’t, they enter the detention cycle.

 

The detention cycle can be involved and I will not delve into it very far. I will say that there are only a few possibilities for products caught up in this cycle. First, they can be denied entry outright and returned to the entity who shipped it. Another possibility is that the product may be reconditioned, if possible. This applies mainly to products with labeling non-conformances in which they may be brought into compliance by simply applying different labeling. There are other possibilities, but they are not generally applicable in the situation of cigars.

 

This rigorous inspection cycle will lead to a variety of other consequences as well. I’ve been told of people who order Cuban cigars from European retailers. They report that the shipments of contraband cigars arrive at their mailbox without any difficulty. This is likely because the shipper has a good relationship with U.S. Customs and its products proceed without examination. Now, with essentially every lot of imported cigars being examined as a result of the new regulations, this practice will likely come to a halt. Once an inspector sees “made in Cuba” on a box of cigars, all bets will be off. (Editor’s note: Many shipments of contraband cigars are not declared as cigars)

 

The bottom line is that if a cigar does not meet the letter of the law, it will not be allowed into the country. The process for making a cigar “legal” for domestic consumption is quite tedious and has not yet been completely defined by the FDA, but we can be assured, sadly, that it will be difficult and expensive for cigar manufacturers to import new blends of cigars into the country.

 

I hope that this has been enlightening for you. Since I have been away from FDA for quite some time, there are likely some differences in what they do with respect to regulated products, but I have learned from some former cronies who are still with the agency that the procedures remain essentially unchanged over the past 20 years.

Thank you Dan for that insiders look at the process! I think this is timely considering recent reports of cigar shipments being opened by customs, whole bundles of cigars cut in half and shipped on to the recipient as if nothing happened. Does it seem right for a government agency to destroy legal property and send it on with out so much as an apology? How is a retailer supposed to sell cigars that have been damaged like that, and they can’t return them for credit. This is where the new regulations are going to effect retailer’s bottom lines first.

I have a couple of IPCPR samples I wanted to talk about, first being the Partagas Ramon y Ramon Robusto. This line pays homage to Ramon Cifuentes, the founder of the Partagas brand, and uses tobacco that was grown in the Dominican Republic from vintage seeds from General Cigar’s library of seeds. The agronomists at General developed a process to regenerate these vintage seeds, and, if I recall, it takes several growing cycles to get a usable crop of tobacco with the right characteristics. The filler is composed of this special, old world tobacco, Nicaraguan Jalapa and Dominican Piloto Cubano, with a Dominican binder and a high priming Cameroon wrapper. This was one of the most interesting and enjoyable cigars I’ve smoked in a very long time. There was a spicy cinnamon flavor throughout the smoke which just kept making me think “wow, this is a delicious cigar!”. The burn and draw were perfect and the cigar had that signature round cap that General Cigar likes to use. This robusto’s size is a bit of a departure from the standard 5½” x 49 Partagas robusto, as they took the ring gauge up to 50. This a great smoke and the list price is in the $7.49-$8.99 range, very reasonable for a terrific cigar. Can you tell I was impressed? Photo is from General’s press kit, it was much better than mine!

After a visit to a newer local store, which I found to be rather lack-luster, with a poorly executed floor-plan and dirty and shabby lounge (although the company and the La Galera El Lector, a 6″x 54 toro which was really nice, but I failed to pay much attention to it), I had to break out the new Joya Black from Joya de Nicaragua. They are branding this along with the Joya Red and have re-branded the doble capa Cabinetta to fit the same design scheme. I’ve been looking forward to trying this San Andrés wrapped cigar since I heard about it. I probably could have chosen a better time when the ambient humidity wasn’t over 80%, as the cigar smokes a bit on the wet side. It had a great flavor though, I’ll be getting my hands on some more to smoke at the right moisture level. It was everything I want in a maduro, less the steamy smoke quality. Unfortunately, you can’t tell if a cigar needs to be dry boxed until it’s too late. Going back to the local shop I visited, it’s a shame that the owners of this chain did what I consider to be a half-assed job with this store. It’s in an area where an upscale, classy shop would do well, and it’s got more of a 7-Eleven feel to it. I hate to be so critical, but I was really disappointed in the place, but not surprised, based on some of the other stores in the chain. I’m sure my harsh criticism will be unpopular with certain people. On a positive note, the pricing was fine, the selection was not bad, although rather “safe”, and the cigar I bought and smoked there smoked well, despite the “store as a humidor” model (I wonder about the practicality of having a door to the outside directly into the humidified space, often they have to overcompensate for this and the cigars are wet).

That’s more than enough for now, I thought about breaking this up into two posts, but I am far to lazy for that on a Sunday morning. Until the next time,

CigarCraig