FDA Interstate Commerce Regs Surprisingly Broad, Major Implications for Stem Cell Clinics

The FDA mandate to regulate drugs and devices often invokes a term called “interstate commerce”.

Like many people I thought I knew what that meant, but probably like most people I was wrong.

After a great discussion on an original post on various key issues related to the many stem cell clinics doing non-FDA approved stem cell “treatments”, the question came up as to whether the FDA has any authority over a biological product if the manufacturer does not introduce it into “interstate commerce” because pertinent laws seem to suggest the FDA’s authority is limited to products introduced into “interstate commerce”.

In other words, we collectively asked in the discussion if a stem cell product for example entirely stays in and is used in the state in which it is made does that mean the FDA has no authority to regulate it? Would the FDA have no authority even if the product is clearly a drug?

It all comes down to the definition of “interstate commerce”.

Further research on the FDA website has revealed that “interstate commerce” and introducing a product into “interstate commerce” does not simply mean shipping your end product from one state to another as so many of us thought.

Yes, moving your product across state lines will trigger the finding that your product was introduced into interstate commerce, but surprisingly apparently so can many other, simpler things.

This big surprise here traces back to the FDA definition of “interstate commerce”. It is not quite intuitive and is extremely broad:

“Interstate commerce” applies to all steps in a product’s manufacture, packaging, and distribution. It is very rare that a cosmetic product on the market is not in “interstate commerce” under the law. For example, at least some of your ingredients or packaging most likely originate from out of state, or even out of the country. ”

In other words, “interstate commerce” does not solely mean that the product that you produce then leaves your state. Rather it also seems to the FDA to be applied to your product if any element of the product or even its production originated from out of your state. While this example above was applied to cosmetics it applies to other products such as drugs as well.

So for example for production of the fat stem cell based product stromal vascular fraction (SVF), the collagenase (traces of which remain in the final product) likely came from out of state. Does that mean the product involves interstate commerce? It would seem so.

The PBS buffer that you used came from out of state? The device you used? Even the plastic tubes?

If you answer “yes” to any of these questions, then the FDA apparently would say that you introduced your product into “interstate commerce”.

Whether it makes sense to you or not as a physician or biologics researcher, it sure seems to be legally binding. A hat tip to commenter J who did more digging on this and found the following that s/he posted in a comment on the original post:

Paul, You may have found the answer, though the most recent case cited is from 1974.

CPG Sec. 100.200 FDA Jurisdiction Over Products Composed of Interstate Ingredients

http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm073820.htm

“Over the years, the courts have reviewed the question of jurisdiction over products made from interstate components. The defense in these cases has been that the finished product is a new entity and FDA lacks jurisdiction until the “new” product is itself shipped in interstate commerce.

The following court cases involving this question establish that FDA clearly has jurisdiction over finished products made from interstate components…”

Therefore, FDA authority on this issue would seem to apply to almost any product as this definition of “interstate commerce” has been supported in the courts.