The skinny on FDA regulation of dietary supplements

Recently I spoke with representatives from the Food and Drug Administration (FDA), and it occurred that there is some confusion about what “regulation” by the FDA means when it comes to dietary supplements.  The term “regulate” has various meanings.

In a general sense, dietary supplements fall under the purview of the FDA – where there are regulations that pertain to labeling and “claims.”  However, when it comes to the measurement of safety and effectiveness – as prescription drugs must do – it is not the same.  The FDA does not ensure potency, purity or biologic activity of the ingredients in dietary supplements.  There is no registration or clearance by the FDA before a dietary supplement goes on the market.

Structure-Function Claims
These claims describe the structure or function of the body (i.e., “supports a healthy immune system or cell function”).  If a company plans on using a structure-function claim on their dietary supplement, they must notify the FDA within 60 days of use.  The moment a dietary supplement label claims that it will treat, control, prevent or mitigate an ailment - it is making a drug claim.

Health Claims
Health claims are acceptable if there is “significant scientific agreement.”  A company may bring supportive information (like scientific research) or organizations like the American Heart Association or the American Medical Association have a consensus on a nutrient in preventing a deficiency-related disease.  For example, in the case of calcium and osteoporosis, there are two approved health claims that may be on a label:

“Adequate calcium throughout life, as part of a well-balanced diet, may reduce the risk of osteoporosis" or "Adequate calcium as part of a healthful diet, along with physical activity, may reduce the risk of osteoporosis in later life." (Click here to learn more.)

As with everything, you need to read the small print.  This is where companies put the following words, “The label claims have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease. Consult your health care professionals before taking any dietary supplements.”  This is supposed to prevent lawsuits.

There is no real definition of the term “natural.”  Many lawyers have initiated class action lawsuits against food and supplement companies using those words on a label.  Consumers do think that natural is a good thing, but hemlock, arsenic, lead, cadmium, mercury are natural.

The FDA has regulations that labeling be truthful and not misleading.  Misleading advertisements in newspapers, magazines, Internet, television or radio, fall under the purview of the Federal Trade Commission.  However, if a product states, “for more information see,” then it is considered an extension of the product and the FDA would have oversight on claims.

There are instances where a dietary supplement may contain substances that are not on the label.  One could argue this is unintentional.  Ask some high school athletes about coaches instructing them to take body building product with hidden steroids.

According to Siobhan DeLancy of the FDA, “Weight loss, sexual enhancement and body building products are most likely to be contaminated with an active drug.  These products have higher adverse effects.  Meridia, a prescription drug that was voluntarily removed at the request of the FDA, has somehow made its way into some weight loss products; some companies are corrupt.”

Adverse Effects
Reporting adverse effects is voluntary.  DeLancy states, “it is more of an art than an algorithm. In the case with Hydroxycut, there were approximately 80 adverse events reported suddenly.  In other cases it can be hard to tease out one ingredient with other factors like drugs, other dietary supplements or underlying disease.”

People may not realize they are having an adverse effect (which does not have to be catastrophic). It can be sudden hair loss, rapid heart rate, nervousness,  impairment to kidney or liver function.

There is faith by the general public, that companies are utilizing good manufacturing practices.  A trust in brands and certain franchises that the products they sell are “safe” from harm.

Consumers should be cautious of where they get their information from… there are drug-nutrient interactions which can be problematic.  It is imperative that you let your health care provider know what dietary supplements you are taking (brands and dosages are helpful), and include your pharmacist in the loop.