The AKA is not in bed with the FDA. They have refused to meet with the AKA for over 3 years.
What is true is that the FDA has expanded its attack on kratom by convincing state regulatory agencies like the Ohio Department of Agriculture that kratom should not be permitted for sale because kratom vendors are marketing kratom as a drug with specific drug claims. This is a transparent misapplication of the Bolger v. Youngs Drug Products case (463 U.S. 60, 66-67 (1983)) where the Court established a “totality of circumstances test” to determine whether the speech is an advertisement, whether it refers to a specific product, and whether the speaker has an economic motive. While none of these factors alone would allow the FDA to classify the speech as “commercial,” together they would.
What the FDA is trying to do is to define kratom by the therapeutic claims made by kratom vendors that would classify kratom as an unapproved drug. Under this theory, the FDA argues that when vendors induce consumers to purchase kratom using such therapeutic claims, they can legitimately characterize these advertisements as commercial speech that allows the FDA to exercise the authority Congress gave them in the Food, Drug, & Cosmetic (FD&C) Act to enforce regulatory control based on whether a vendor claim is false or misleading. If successful, the FDA can limit even truthful speech because the kratom product being advertised is not a drug approved by the FDA.
Our defense is to demonstrate to regulatory agencies that the kratom consumer population is not represented by commercial speech, and in fact is actively engaged in repudiating such impermissible health claims under the FD&C Act. That prevents the FDA from making the claim to any regulatory agency they should regulate kratom as a drug, but rather recognize and regulate it as a food or dietary ingredient based on its intended use by consumers -- who have the right under noncommercial speech rights recognized by the courts.
Some vendors are upset that they will have to make the investments in equipment to assure kratom products are properly manufactured and meet good manufacturing practice standards required of food vendors to assure consumers their products are not contaminated. In fact, if the FDA were properly regulating kratom today those standards would apply to all kratom manufacturers. Just look at a bottle of water or a soft drink and you will see the labeling requirements imposed by the FDA for such food products.
The new AKA Truth in Labeling Program will protect kratom from another regulatory overreach by the FDA and provide kratom consumers with a legitimate defense when we litigate these issues in OOhio. The FDA has REFUSED to even properly review new dietary ingredient applications by kratom vendors which demonstrates they are not willing to recognize the legitimate uses kratom consumers have the right to use kratom for in maintaining their health and well-being.
I have immense respect for those who have been involved in the fight like Paul and Will, and while we may occasionally have internal disagreements on strategies and tactics, I have no doubt kratom advocates like them are warriors who deserve respect. They have mine.