The age old question that has existed for as long as the kratom industry has lived circa 2008:

Not for Human Consumption or For Human Consumption? (For Retail Stores)

It’s a heated debate that will turn friends into enemies and companies into court cases.

The following below has been written and approved by our lawyers ($$) so you can bet your bottom dollar that this is not just our opinion but a legal opinion from some of the best in the business.

Please note that this messaging is in regards to retailers selling Kratom that is for Human Consumption. If you are selling a product that is Not for Human Consumption, there is no problem with it if you are following the law and your product really is not for human consumption.

“Not For Human Consumption” Labeling is Dangerous for Retailers

Any product sold for consumption, whether it is food, a drug, or dietary supplement, must be labeled and sold according to FDA regulations. Some manufacturers have tried to circumvent those regulations by labeling their products as “Not For Human Consumption.”[1] (“NFHC”) However, these attempts to skirt FDA regulations are likely to be unsuccessful, and they put most of the legal risk on the retailer. Retailers who sell products that are labeled NFHC run the risk of charges of mislabeling under the Food, Drug and Cosmetic Act, (“FDCA”) or fraud under state laws.

Mislabeling

The Federal Food, Drug and Cosmetic Act (FDCA) defines a products’ label as both the actual label affixed to the product, and also any written material contained in any product wrapper and also anything accompanying the product. As if that weren’t bad enough, courts have allowed the FDA to define “accompanying” extremely broadly.

Facebook likes are defined as labeling! Websites are defined as labeling!

Anything on a manufacturer’s website or social media that references consumption, in any way, could lead to a charge that the product is mislabeled. A customer posting a testimonial on a manufacturer’s website about the benefit she got from consuming the product, if it is “liked” by the manufacturer, would count as “labeling” and could lead to a mislabeling charge.

Are you certain that there is nothing on your manufacturer’s Facebook page that implies consumption? The distributor?

The danger of NFHC-labeling is that it makes prosecutors’ jobs very easy. To prove mislabeling, they simply have to prove that the product is intended for consumption.

Fraud

If a retailer is selling a product that is labeled NFHC, but it is, in fact, for human consumption, that could support a charge of fraud. Prosecutors will look well beyond the labeling of a product to determine that it is intended for human consumption – an NFHC label is meager protection. And retailers have been charged with fraud. A store was charged in 2012 with fraud for selling kratom tea and capsules that were labeled NFHC. The prosecutor pointed to the facts that the labeling included directions for steeping the tea, and employee recommendations for how to smoke the products in a pipe. Many prosecution manuals explain what evidence to look for in determining that a product is for human consumption, but Sarasota County, Florida, spelled out in their recent designer drug regulation some specific indices of human consumption, including:

The product is packaged in quantities that suggest human consumption.

The product is displayed alongside other human consumables.

Significant price differences between the substance sold and the substance as it is purported to be.

The product is kept behind the counter or hidden from ordinary view, or sold with a code word.

The product is kept in close proximity to drug paraphernalia.

As a retailer, are you certain that the product labeled “NFHC” is selling for the same price as similarly labeled incense? Bath salts? Botanical samples?

The Retailer Faces a Greater Risk from NFHC than the Manufacturer

A retailer selling a product labeled NFHC presents a compelling target for state and local prosecutors, much more so than the manufacturer. A manufacturer might be out of state from the prosecutor. The manufacturer might be able to pick up and move, compared to a retailer who is unable to close up shop and relocate. The manufacturer is primarily regulated by the FDA, and is a little fish compared to the large pharmaceutical companies the FDA normally targets. By contrast, a retailer is primarily regulated by state and local prosecutors and may represent a much greater target relative to other businesses.

Consider: The FDA has to decide between prosecuting a multi-billion dollar pharmaceutical giant or a minor manufacturer. A state or local prosecutor may be deciding between prosecuting a multi-million dollar a year retailer and a low-level dealer.

Dietary Supplement Labeling Can Provide Protection to the Retailer

Selling a product that is labeled as a dietary supplement is much less risky to the retailer. It implies that the manufacturer has done the due diligence to get the product on the market appropriately. A retailer can compare the labeling of an established dietary supplement to the proposed new product and get a sense of whether the manufacturer has made a good-faith effort to comply with FDA regulations.

Ask your manufacturer or distributor through what regulatory pathway is the product on the market? A dietary supplement must be one of the following:

An “Old Dietary Ingredient” – one that was on the market prior to October 15, 1994

A “New Dietary Ingredient” with a New Dietary Ingredient Notification submitted to the FDA

A “New Dietary Ingredient” that is exempt from the Notification requirements.

Several manufacturers have done the due diligence and determined that their kratom is appropriately on the market as a “New Dietary Ingredient” exempt from notification requirements because it was in the food supply in Thailand.

Selling a product that is labeled as a dietary supplement provides a good-faith defense to the most likely charges. To prove mislabeling, a prosecutor would have to prove that the product in question is not a dietary supplement, but a drug – that statements made in labeling suggested the product was intended to treat, cure, or diagnose a disease. That’s more difficult than simply proving that the product was intended to be consumed. Also, dietary supplement labeling will almost eliminate the risk of fraudulently labeling a product NFHC when it is actually for human consumption.

Applying these tests to an unnamed NFHC product.

Some packages say that the product is intended only as a “botanical specimen” and that the capsules are intended only as carriers to “help facilitate the handling of raw powder.” But, the packages also note that the kratom contained therein is the “most potent in the world.” These packages also contain the warning that the FDA has not evaluated the product and that it is not intended to diagnose, treat, cure, or prevent any disease. On their website, they warn that pregnant women should not use the product. They suggest that retailers try a sample package and “test the results for yourself.” Each of these would support a court finding that the products are, actually, intended to be consumed. Even their warning that they cannot provide dosages or dosing instructions (don’t even ask) would be evidence that the product is intended to be consumed. If the product were actually being sold as a botanical specimen, and the capsules really were to facilitate the handling of raw powder, none of these warnings or disclaimers would be necessary.

Retailers need to ask themselves, if prosecutors come knocking, would you rather be defending products that are obviously falsely labeled, or would you rather be defending products that made a good-faith effort to comply with FDA regulations?

[1] Synonyms: Plant food, potpourri, bath salts, incense, botanical samples, etc.