New FDA Initiative Circulating the Net Does NOT Warrant Alarm or Action

[Guest guest]

New FDA Initiative Circulating the Net Does NOT Warrant Alarm or Action

 

http://v.mercola.com/blogs/public_blog/New-FDA-Initiative-Circulating-the-Net-Do\

es-Not-Warrant-Alarm-or-Action-12707.aspx

 

I have received dozens of requests to promote a response to the FDA Guidance

for Complementary and Alternative Medicine Products

http://www.fda.gov/OHRMS/DOCKETS/98fr/06d-0480-gld0001.pdf 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 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.â€Â  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 (“DEAâ€

) 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.