As in previous warnings to kratom supplement marketers linked to opioid addiction treatment claims, FDA tells Cali Botanicals and Kratom NC that HHS in 2017 found opioid abuse was nationwide public health emergency and FDA is targeting products that without approval claim to diagnose, mitigate, prevent, treat or cure opioid addiction. Contract manufacturer Somlabs' GMP problems also were identified in FDA's latest warning letters.

Firms' US distributors deal with fewer customers because compensation no longer linked to recruiting multilevel networks of distributors. "The way you reached more customers is you signed one of your customers up as a rep, and they went and reached more, and that was the nature of the business model," says co-president John DeSimone. Today, distributors need larger variety of products to offer customers in the health, wellness and fitness space.

Rep. McNerneny's amendment calls for process that would follow steps FDA used in exercising enforcement discretion on natural products that contain levels of an approved drug ingredient, with red yeast rice most notable. But critics of FDA's VMS industry oversight don't see McNerney's amendment as effective not only for strengthening FDA's overall regulation but also for solving its CBD problem.

"A foundation of this business has been," says Perrigo's Americas consumer business chief, Jeffrey Needham, "we are a fast follower. That's been our traditional model. We can't afford to do that going forward." In addition to initiating moving ingredients from Rx to OTC, firm is developing "national better brand" versions of drugs already available OTC.

"FDA meetings with an individual manufacturer regarding inclusion of ingredients in the monograph ... could have broad applicability, and hence are generally public," CDER says. But, "regulations permit any person to request a private meeting, and FDA will make reasonable efforts to accommodate such requests."

Agency says "some credible evidence" suggests intake of  EPA and DHA "may reduce the risk of hypertension by lowering blood pressure, this evidence is inconclusive and highly inconsistent" and does not support actual approval of a qualified health claim.