Here's the relevant section:
The bizarre controversy revolves around the FDA's attempt to regulate the Centeno-Schultz Clinic in Colorado that performs a nonsurgical stem-cell therapy called Regenexx-C. It is designed to treat moderate to severe joint, tendon, ligament, and bone pain using only adult stem cells. Doctors draw your blood, spin it through a centrifuge, extract the stem cells and re-inject them into your damaged joints. It uses no other drugs. No drugs means no FDA oversight and that does not sit well with the administration.This is stretching the claimed limits of government power into hyperspace. By that "reasoning", the government could regulate anything that might alter what sorts of medications you might purchase from out of state, such as an exercise machine. (Via Instapundit.)
The FDA has since argued that a) stem cells are drugs and b) they fall under FDA regulation because the clinic is engaging in interstate commerce. That's right, a process performed at the clinic using the patient's own bodily fluids constitutes interstate commerce because, according to the administration, out-of-state patients using Regenexx-C would "depress the market for out-of-state drugs that are approved by FDA."
Related: Michelle Minton of the Competitive Enterprise Institute describes the latest FDA overreach with respect to dietary supplements at her 1/31/2012 OpEd for The Hill, "The FDA has it dead wrong":
[T]he NDI draft guidelines released by the FDA this summer would create a de facto pre-approval process on virtually all supplements on the market, thus giving the agency carte blanche to pull any supplement off the shelf without the need to prove that it is unsafe.As Minton notes, the FDA's efforts are a "rogue effort to unilaterally expand its authority". Fortunately, some in Congress want to rein them in, at least on this issue. Let's hope they are successful.