I am rather surprised that FDA issued this guidance document because it does not tell us anything that we didn't already know, i.e., FDA has the regulatory authority to regulate products and devices that are used in the practice of complementary and alternative medicine. 

The key words are "products" and “devices.”  FDA stops short of stating that it has the ability to regulate the practice of medicine.  For instance, any topical or ingestible product that is market for the cure, mitigation, treatment, diagnosis, or prevention of a particular disease condition is considered a "drug" by the agency.  There are numerous cases on this point going back decades regarding FDA’s regulatory authority over such products so FDA’s position is well-founded on this issue. 

However, in recent times, FDA has generally ignored this area of medicine and has left it to individuals to pursue the course of treatment they believe is necessary as long as FDA did not perceive that the product or device did not pose a risk to public safety.  Thus, this document does strike me to be a new attempt by FDA to reassert itself in this space. 

How serious the agency is about reasserting itself is difficult to gauge because the key to determining whether a product is regulated as a drug, medical device, cosmetic, food, or dietary supplement depends on the products intended use. 

Specifically, intended use is generally determined by the product’s label, labeling, and on occasion advertising.  Thus, if a company were marketing its dietary supplement product with appropriate structure/function claims, FDA could not seize the product because practitioners are using it to treat their patients. 

Moreover, FDA would be hard pressed to take action against a practitioner because how a practitioner uses an otherwise lawful product is within the practice of medicine, which FDA does not have regulatory authority over.  With that said, practitioners that have developed their own line of supplements could be challenged by the agency on this issue. 

So, I do have some concern that FDA may be indicating that it could regulate transactions between a doctor and their patient.  However, this document stops short of stating that FDA would or could.  

The few instances that I know of where the agency has arguably attempted to regulate the practice of medicine is with medical devices and controlled substances, in particular hGH.  In the 1990's, FDA went after several doctors who were using TENS units in their practices.  The units being used, however, had not received clearance from the FDA. 

Thus, FDA’s argument is that it was not regulating the practice of medicine, but rather the TENS unit itself.  FDA was successful in eliminating those units from the doctors’ offices because the devices lacked the proper regulatory clearances to be marketed in the United States.   It is another matter, however, where a product is properly marketed but a practitioner is not using the product consistent with its intended use.  In this latter scenario, the agency would likely avoid taking regulatory action because the status of the product is legal. 

For instance, there are now several TENS devices that have been cleared by FDA.  If a doctor chose to use one of those devices in a manner not consistent with its clearance, this is arguably not an FDA issue unless the manufacturer or distributor of the device is promoting it for an off label use.  Indeed, the courts have generally recognized a physician’s right to use or prescribe a lawful drug for a use not indicated on the particular product’s label or labeling. 

I have also seen FDA as well as the Drug Enforcement Administration (“DEA”) take issue with the off-label use of controlled substances, in particular anabolic steroids and hGH.  However, the Controlled Substance Act does provide a reasonable basis for the agencies to regulate the practice of medicine when it comes to these particular substances.  So, I do not consider this situation analogous.

In Summary

While I am surprised that FDA issued this guidance document, it does not contain anything new regarding FDA’s position that the products and devices used by complementary and alternative healthcare practitioners are subject to its regulatory authority.  Indeed, FDA has steadfastly taken the position that if these products are marketed to cure, treat, mitigate, diagnose, or cure disease; the products are subject to FDA’s regulatory authority as a drug, biologic, or medical device. 

The guidance document stops short of stating that FDA has the authority to prohibit a practitioner from using a lawfully marketed food, dietary supplement, cosmetic, or device to treat or prevent a disease.  However, there is some implication that if the product is the practitioner’s own product that FDA could take issue with it even if the product is properly label in the first instance.  Whether FDA is willing to actually pursue a practitioner over an otherwise legal product is doubtful because it raises serious issues of whether FDA is attempting to interfere in the practice of medicine. 

With that said, if the product is being marketed unlawfully, FDA believes it has the authority to pursue the unlawful use of the product because it is not attempting to regulate the practice of medicine but simply removing an unlawfully marketed product from the marketplace.