The FDA Doesn't Like (or Trust) Us

Thats really the most truthful and accurate way of putting it, although the U.S. Food and Drug  

Administration (FDA) would never say that explicitly. The agency has been licking its wounds since the Hosmer-Proxmire Vitamin Bill conflict of the 1960s and 1970s and the Dietary Supplement Health and Education Act (DSHEA) battle of the 1990s, and it scarcely hides its animus towards the natural industry in its official pronouncements.

In the FDAs Q&A on Dietary Supplements, the agency writes: In October 1994, [] DSHEA was signed into law by President Clinton. Before this time, dietary supplements were subject to the same regulatory requirements as were other foods. This new law, which amended the Federal Food, Drug, and Cosmetic Act, created a new regulatory framework for the safety and labeling of dietary supplements. Under DSHEA, a firm is responsible for determining that the dietary supplements it manufactures or distributes are safe and that any representations or claims made about them are substantiated by adequate evidence to show that they are not false or misleading. This means that dietary supplements do not need approval from FDA before they are marketed.

You can almost see the FDA shrugging its shoulders and sighing as it says the above. Never mind that on June 18^th, 1966, the FDA announced that it was going to effectively ban nutrient potencies above 100 percent of the RDAs by classifying these nutrients as drugs.

Never mind the FDAs witch-hunt against supplements with armed raids of health-food stores and practitioners offices in the 1980s and 1990s. In the 1990s, the FDA was improperly using the food-additive provisions in the law to go after supplements it didnt like, such as L-tryptophan, the most outrageous event related to which was the FDAs raid of Dr. Jonathan Wrights Tahoma Clinic on May 6^th, 1992, during which staff and patients were terrorized by armed sheriffs who had been deputized by FDA agents. The crime? Dispensing legally obtained L-tryptophan to his patients.

Notwithstanding adverse events reports stemming largely from a handful of spiked or irresponsibly used products, it didnt like ephedra, either, and so that is now gone. Same with DMAA, all other factors aside.

In late last year, the HHS Office of the Inspector Generals (OIG) office issued a report entitled Dietary Supplements: Structure/Function Claims Fail to Meet Federal Requirements, which found that 20 percent of the dietary supplement products in their sample (26 products out of 127 total) contained prohibited disease claimsalbeit, not good. Sixty-seven products were purchased from stores and 60 were purchased online.

I submitted a Freedom of Information Act (FOIA) request asking the agency to divulge the names of the products, manufacturers, and where purchased. Because my suspicion was, and is, that all, or almost all, of the violative products were purchased from shady online discounters in the agencys hope that these online products would likely be associated with prohibited language. I also thought that if the industry knows which companies products were singled out, the companies could take immediate steps to come into compliance, either with our without industry self-regulatory efforts to assist.

The request was denied on procedural grounds (saying that this one-page table was part of pre-decisional deliberations), so I filed an appeal, this time taking out the request for where purchased, and citing numerous precedents, but this was denied as well.

And while the same reasons were cited officially, I was told by one agency analyst that the denials were also, perhaps mainly, due to the agencys reluctance to show what language was in violation because that would help natural product industry companies to skirt the law!

So much for trusting our industry to try to do the right thing.

I said, in return, that the opposite would be true. It would not encourage deception but it would, in fact, encourage compliance, because the industry would have a better read on structure-function language that the agency is likely to object to. Companies would be able to comply better before going to market with products and not have to go out of business defending themselves from the FDA, and the government would save tens of millions of our taxpayer dollars in not having to build and prosecute each of the 26 cases. 

But that was not persuasive. Why? Because the FDA is a law enforcement agency whose job it is to go after companies.

The agency is not truly interested in helping people comply; they are much more interested in catching companies that have made mistakes and making an example of them.

Its no wonder then that the vast majority of natural industry companies that are responsible and set very high bars of accuracy, quality, and efficacy for their products are very frustrated when reports like this come out, or books, or Congressional critics keep attacking our industry and its products.

And, yes, can trust me on that.