I have received dozens of requests to promote a response to the FDA Guidance for Complementary and Alternative Medicine Products issued by the FDA in February 2007. There have also been many people posting about this on Vital Votes.
It has never been my intention to cry wolf and encourage response to any government initiative unless I was convinced it warranted it.
So, I invested in a legal consultation and paid one of the top Washington DC lawyers that defends against FDA actions $500 an hour to review the initiative and provide his impression of the proposal.
After reviewing his analysis and consulting with two other attorneys, my take is that this proposal does not warrant a response.
The primary reason for this? The Guidance does not create any new regulations; rather it’s an explanation of how the FDA applies the existing regulations.
The Guidance explains the differences between foods, food additives, dietary supplements and drugs, and it explains how the same item may be considered a food, a dietary supplement, or a drug depending on the labeling and claims made.
Meanwhile, the Guidance does NOT prevent access to CAM providers, nor does it prevent the use of supplements/herbs by medical professionals in their practice. It also will not directly impact consumers/patients or prevent doctors from recommending the use of healthy foods to patients.
This is not meant to minimize any of the underhanded dealings going on at the FDA (like the fact that the majority of funding for the FDA comes from the very companies that it is seeking to monitor and evaluate), just put our efforts where they’re most needed.
National Health Federation April 27, 2007
My Attorney's Review of the Legislation
I am rathersurprised that FDA issued this guidance document because it does not tell usanything that we didn't already know, i.e., FDAhas the regulatory authority to regulate products and devices that are used inthe practice of complementary and alternative medicine.
The key words are"products" and “devices.” FDAstops short of stating that it has the ability to regulate the practice ofmedicine. For instance, any topical or ingestible productthat is market for the cure, mitigation, treatment, diagnosis, orprevention of a particular disease condition is considereda "drug" by the agency. There are numerous cases on thispoint going back decades regarding FDA’s regulatory authority over suchproducts so FDA’s position is well-founded on this issue.
However, in recent times, FDA has generally ignored thisarea of medicine and has left it to individuals to pursue thecourse of treatment they believe is necessary as long as FDA did not perceivethat 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 reassertitself in this space.
Howserious the agency is about reasserting itself is difficult to gaugebecause the key to determining whether a product is regulated as a drug,medical device, cosmetic, food, or dietary supplement depends on theproducts intended use.
Specifically, intended use is generally determined by theproduct’s label, labeling, and on occasion advertising. Thus, if acompany were marketing its dietary supplement product with appropriatestructure/function claims, FDA could not seize the product becausepractitioners are using it to treat their patients.
Moreover, FDA wouldbe hard pressed to take action against a practitioner because how apractitioner uses an otherwise lawful product is within the practiceof medicine, which FDA does not have regulatory authority over. Withthat said, practitioners that have developed their own line of supplementscould be challenged by the agency on this issue.
So, I do havesome concern that FDA may be indicating that it could regulatetransactions between a doctor and their patient. However, thisdocument stops short of stating that FDA would or could.
The few instances that I know of where the agency hasarguably attempted to regulate the practice of medicine is with medical devicesand controlled substances, in particular hGH. In the 1990's, FDA wentafter several doctors who were using TENS units in theirpractices. The units being used, however, had not received clearancefrom the FDA.
Thus, FDA’s argument is that it was not regulating thepractice of medicine, but rather the TENS unit itself. FDA was successful in eliminating thoseunits from the doctors’ offices because the devices lacked the properregulatory clearances to be marketed in the United States. It is another matter, however, where aproduct is properly marketed but a practitioner is not using the productconsistent with its intended use. In this latter scenario, the agencywould likely avoid taking regulatory action because the status of the productis legal.
For instance, there are now several TENS devices that have beencleared by FDA. If a doctor chose to use one of those devicesin a manner not consistent with its clearance, this is arguably not an FDAissue unless the manufacturer or distributor of the device is promoting it foran off label use. Indeed, the courtshave generally recognized a physician’s right to use or prescribe a lawful drugfor a use not indicated on the particular product’s label or labeling.
I have also seen FDA as well as the Drug EnforcementAdministration (“DEA”) take issue with the off-label use of controlledsubstances, in particular anabolic steroids and hGH. However, the Controlled Substance Act doesprovide a reasonable basis for the agencies to regulate the practice ofmedicine when it comes to these particular substances. So, I do not consider this situationanalogous.
While I am surprised that FDA issued thisguidance document, it does not contain anything new regarding FDA’s position thatthe products and devices used by complementary and alternative healthcarepractitioners are subject to its regulatory authority. Indeed, FDA has steadfastly taken theposition that if these products are marketed to cure, treat, mitigate,diagnose, or cure disease; the products are subject to FDA’s regulatoryauthority as a drug, biologic, or medical device.
The guidance document stops short of statingthat FDA has the authority to prohibit a practitioner from using a lawfully marketedfood, dietary supplement, cosmetic, or device to treat or prevent adisease. However, there is someimplication that if the product is the practitioner’s own product that FDAcould take issue with it even if the product is properly label in the firstinstance. Whether FDA is willing toactually pursue a practitioner over an otherwise legal product is doubtfulbecause it raises serious issues of whether FDA is attempting to interfere inthe practice of medicine.
With thatsaid, if the product is being marketed unlawfully, FDA believes it has theauthority to pursue the unlawful use of the product because it is notattempting to regulate the practice of medicine but simply removing anunlawfully marketed product from the marketplace.