Selling Kratom Products? Your Guide to FDA Restrictions
Kratom is huge right now. But the FDA is putting some kratom marketers under fire. Don’t make false claims about kratom. Here’s your guide.
More than 100 people die every day from an opioid overdose in the US. Though the opioid crisis centers on pharmaceutical painkillers, the FDA is drawing a dotted line to Kratom.
The herb dates back centuries and grows in the tropics of southeast Asia. Its relaxant quality comes from the opioid-like effects built into the leaves of the Mytragyna Speciosa tree.
Users can chew the leaves, grind them and add to drinks, or take in capsule form. Alkaloid properties within the leaves bind to opioid receptors in the brain.
This connection offers relief from pain and anxiety and can provide quick energy.
Proponents prefer this natural remedy over prescription medications, and long-time prescription users report that withdrawal from these prescriptions is more comfortable with Kratom products.
The FDA has strict guidelines over prescription medications, this is not so with Kratom. And yet, the FDA is keeping a close eye. Keep reading to find out why that is, and what you need to know about Kratom.
Why the FDA Monitors Kratom Products
By law, Kratom products are herb supplements, which have no FDA oversight. But, the FDA’s lack of direct control doesn’t stop them from issuing warnings.
Their efforts to ban the substance continue to fail due to the widespread support. So, they are left to release information to the public about side effects.
Though Kratom has a long history, few clinical studies show solid results. In the absence of facts, the FDA relies on monitoring the sales of Kratom.
Today, the government office is cracking down on marketers. Those who attempt to sell kratom as a “cure” for everything from cancer to arthritis are taking heed.
For buyers, there’s more reason than ever to find reputable dealers. For sellers, marketing Kratom has boundaries.
Both rely on facts rather than claims. Read more here.
Kratom Sales in the US
To say that Kratom sales in the US have been increasing in the last decade is an understatement. By 2016, there were 3-5 million users, bringing revenue to a few billion dollars.
The powerhouse’s popularity grows even as FDA and DEA continue to warn users of its dangers. Some may try Kratom from curiosity. But ardent users report pain and anxiety relief as their primary reasons for use.
Where It’s Illegal to Sell Kratom
Through all the debate and warning, Kratom is legal in most states. A few states ban it altogether, and a few cities in the US follow suit.
Much of Kratom’s sales occur online, and those who buy it may not live in areas with a ban in place.
States that ban Kratom include:
- Washington DC
- Rhode Island
There are also certain cities and counties that ban Kratom. These include:
- San Diego and Oceanside, California
- Sarasota County, Florida
- Jerseyville, Illinois
- Ontario, Oregon
- Union County, Mississippi
Also, some areas have restrictions on which forms of Kratom are legal and age limits for sale.
- New Hampshire: must be 18 to buy Kratom
- Tennessee: only plain leaf Kratom is allowable, and you must be 21 to buy
Outside the US, there are bans in these countries for buying, selling, and possession of Kratom:
These countries do not ban Kratom, but have strict controls in place:
- New Zealand
In the US, the FDA is beginning to place restrictions on marketing for Kratom. The attempt to stop sellers from misbranding comes in the form of warning letters.
What’s Allowable in Kratom Marketing
The FDA’s stance that there is not enough known about Kratom lies at the heart of “misbranding” the herb. The argument is that their office has no approval in place for branding Kratom.
The fact that Kratom is an herb supplement releases the FDA of any obligation to regulate it. It seems the “opioid” effects of Kratom is at the heart of the reason the FDA believes they have a duty to inform.
With overdoses skyrocketing, the term sends some scrambling for closer scrutiny. Kratom advocates point to the deaths in which the deceased had the herb in their system. Only one death shows kratom as the single substance present. Each of the others shows many substances, including prescription medications.
As the debate continues, the FDA seeks to limit marketing as they do with any supplement.
Because there is no FDA approval for Kratom, sellers may market it as other supplements on the market.
What’s Not Allowable in Kratom Marketing
Because there are few studies on the effects of Kratom, it’s vital to stick to the facts. No two people will experience the same benefits.
So, sellers rely on customer self-reporting on collective outcomes. A user who reports their use of Kratom assists with pain relief is frequent. It’s also popular to use of the herb in easing withdrawal from prescription pain meds.
But the FDA gets uneasy about espousing Kratom as a “cure” for anything. Warning letters go out to vendors who avoid helping their customers use the product through a safe means. Dosage amounts, as well as precautions, should be available.
In addition, most sites cross state lines. This means that the FDA pays close attention to interstate commerce rules.
“Misbranding” drugs is extolling unproven benefits or failing to disclose side effects. Either will incur an FDA warning.
Why Kratom Products Have Strong Support
It is not only customers who lean toward keeping Kratom available. The industry and lawmakers with Kratom fans in their district continue to support the herb. And because it represents a billion dollar industry, there is much at stake.
Today, Kratom sellers can point to steep losses if it becomes unavailable. There will be losses in employment, tax revenue, and charitable contributions.
Of the few states considering a ban in recent years, the majority dropped all proposals. One reason for reconsideration is hefty positive consumer responses for its use.
Many point to the differences between the herb and opioids to argue the FDA stance.
Experts say the amount of Kratom necessary to mimic opioids causes more illness than euphoria. It’s inherent ability to upset the stomach prevents over-medication and limits abuse.
Need More Small Business Advice?
Want to understand government regulations on Kratom products or how to market them? We have what you need.
Let us help you get your business off the ground or improve your great idea. Check out our latest articles, like this post on what to do if you can’t afford your medical bills.