Tuesday, June 14, 2016

Ruling of the Week 2016.13: Kimera Koffee

If you have been around here long enough, you know I am a skeptical guy. I believe the consensus of medical science is in a better position than the guy at the supplement store to give medical advice. I also believe that eating or drinking something with the intention of modifying the way your body works is a medical decision whether you are taking a prescription drug or a "natural" supplement. I suspect the prescription drug has a better chance of actually working as advertised than does the supplement, but both are drugs.

With that in mind, I read HQ H268556 (Dec. 15, 2015), which considers the tariff classification of Kimera Koffee. This particular product is about 95% coffee, but it has been "boosted" with taurine, alpha GPC 50%, L-theanine, and DMAE (Deanol). As  result, the coffee is advertised as enhancing cognitive performance, boosting energy levels, improving focus and concentration, and enhancing athletic performance.

The additives are a class of products known a nootropics, also called "smart drugs." Here is a good overview of the science of nootropics from Yale neurologist Dr. Steven Novella. The article does not address the specific additives in Kimera Koffee, but the conclusion is interesting. Stimulants provide a subjective experience of enhanced performance. That makes me think that the caffeine in the coffee might be the nootropic we all already know and love. Personally, I like my nootropic in the form of a cappuccino from Intelligentsia in Chicago.

I'm not saying that the additives in this product don't work. I don't know that, and I suspect they do provide an additional jolt. But, there are a couple legal issues raised.

First, what about the tariff classification? In the ruling, Customs had to decide whether this is coffee of HTSUS Heading 0901 or preparations of coffee in Heading 2101. According to prior rulings, a preparation of coffee includes coffee with sugar, milk, etc. regardless of changes in the finished products' physical characteristics. But, coffee mixed with natural or artificial flavors has been classified as coffee, rather than as a preparation.

Although the added supplements are not flavorings, Customs believes the analysis is similar. This did not get a lot of analysis, and I think it is legally dubious. But, there it is. Customs classified this product as coffee in subheading 0901.21. As a side note, coffee of 0901.21 is exempt from country of origin marking.

The second question I have is whether this should be regulated as a drug. Assuming it falls into the category of supplements rather than drugs, it should be labeled to say that the statements about performance enhancement have not been evaluated by the FDA and that this coffee is not intended to diagnose, treat, cure, or prevent disease. That is the magic get-out-of-FDA-jail-free card for supplement sellers. Section 201(g) of the Food, Drug & Cosmetics Act defines a drug as, in part, "articles (other than food) intended to affect the structure or any function of the body of man or other animals." By its own advertising, this coffee is designed to affect the function of the human brain. By my reading, that is a drug. Of course, I can also get a cup of coffee with my apple pie, making it food. That is enough to take it out of the scope of the Act. Is that the right analysis though? It seems that by adding those ingredients to coffee for the purpose of affecting brain function, the coffee is being used as a delivery system rather than food. If I put insulin in chocolate pudding, is it no longer regulated as a drug?

Lucky for me, this is the Customs Law Blog and I don't need to know the answer to these questions. If you, on the other hand, are a F&D lawyer, please let me know how this plays out for Kimera Koffee and similar "boosted" products.

1 comment:

Larry said...

UPDATE FROM AN ACTUAL FOOD AND DRUG LAWYER.

Well done on a fascinating post, Larry. I won’t pretend to fully understand the strange ways of the customs world, but we here in the Food and Drug Law bar never tire of re-visiting basic concepts in the interest of spreading better understanding and good cheer regarding out little corner of the legal world.

First, it’s always useful and sort of fun to point out that a key component in the statutory definitions of food, dietary supplement and drug is a product’s ‘intended use.’ The intent of the manufacturer or other proprietor of the product is what is being referred to, and it’s all-important to the determination of which type of product an article is, and, therefore, how it will be regulated. Almost more than the chemistry of a product (though that is relevant), it’s the intended use that points the needle toward drug or food, for example. Intended use is gleaned from labeling, and also from advertising and other statements of the manufacturer, and even sometimes from the actual use to which consumers put a product.

Second, while it’s true that one way a product can be considered a drug under the law is if its intended use is to affect the structure or function of the body, as it happens, dietary supplements are given explicit statutory permission to make such claims of effect and not thereby be considered drugs. In this sense, they have health-related effects but look and taste and are eaten as foods and are regulated as foods. Why, they are the Platonic form of a law school exam question on products that fall somewhere between food and drugs. But the key is the rules for them are a little different than those for either traditional foods or drugs.

Finally, in defense of dietary supplements worldwide, I hereby rise in opposition to the myth that dietary supplements are “not regulated” by FDA, which phrases like “magic get-out-of-FDA-jail-free card for supplement sellers” invokes. Dietary supplements are, because they are foods, not approved for marketing in advance by FDA the way new drugs are, but ARE required to, for example, only make label claims for which the makers have adequate substantiation, must feature the disclaimer you referred to on their labels (“This claim has not been evaluated by the FDA….”) when they make a claim of effect on the structure or function of the body, be manufactured in accordance with detailed Good Manufacturing Practices regulations whether made in the US or overseas, feature labels containing a range of detailed information, report serious adverse reactions, must refrain from making many disease-related label claims, must give FDA prior notice when they contain a new dietary ingredient, and the facilities that make them have to be registered with FDA whether domestic or foreign and are subject to inspection and the full range of FDA regulatory penalties for violations including criminal penalties.
Just. Sayin.
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Eric F. Greenberg
Eric F. Greenberg, P.C.
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