One of the most frequent comments I’ve seen in the media about the nutritional supplement industry is that “there is no oversight” over manufacturing processes and supplement claims. We have a full-time regulatory staff who laugh when they hear this, because if that were true they’d be spending a great deal of time and energy for nothing.

In fact of course, FDA has direct oversight over nutritional supplements; FTC has overlapping authority when it comes to the claims that are made (even if a health claim isn’t being made, which would come under FDA authority, it’s possible to run afoul of FTC if the claims are not supportable).

I think a more accurate statement might be that “Nutritional supplements don’t have to meet FDA pharmaceutical product standards.” So what would that difference mean in practical terms?

First of all, a little history. FDA was established in 1906 to protect the American consumer and promote health. Currently the list of things this agency regulates includes both prescription and OTC drugs, nutritional supplements and cosmetics, but also includes food safety, tobacco products, vaccines and others. Historically supplements fell in a grey area, since they were neither foods nor drugs; regulations that made sense for either of those broad categories don’t fit for supplements, so eventually a set of regs for supplements was developed. At first no claims were allowed, but eventually Congress passed DSHEA (the Dietary Supplement Health Education Act), which states that supplements are for generally healthy people, and claims around structure or function could be made (in addition to “prevention of vitamin deficiency” statements). For example, “calcium is important for bones” would be a structural claim, and “vitamin E protects against oxidative damage” would be a functional claim.

Note however that first caveat, that “supplements are for generally healthy people.” FDA regulations state that “supplements cannot be used for the treatment, prevention or amelioration of a disease or condition, or the symptoms of a disease or condition” (somewhat paraphrasing here, but the general sense is the same). So a supplement company couldn’t say, for example, that “vitamin C is to treat the common cold.” (Even though most people who take vitamin C would say that’s exactly what they take it for). Since cold and flu are “diseases or conditions,” that statement would be considered by FDA to be making a drug claim, and would get the company making the claim in trouble.

Anyhow, back to regulatory oversight. FDA does in fact regulate the nutritional supplement company pretty closely, given their available resources. Since cGMPs (current Good Manufacturing Practices) were instituted in 2012 (when the law went into full effect), FDA has been conducting inspections of supplement manufacturing companies, and has issued a number of Regulatory Letters warning companies that they needed to clean up their procedures or face pretty stiff penalties, up to getting shut down. (This usually happens only after several warnings have been ignored or not acted upon appropriately, but it has happened on more than one or two occasions.)

So the next time you hear someone say that the supplement industry is unregulated, you’ll be better prepared to correct the misinformed speaker!