August 4, 2016 general

Considering the spin that the FDA and the likes of Consumer Reports give supplement regulation, a person might think it is risky to buy vitamins and other supplements in a health food store. However, I assure you that it isn’t the wild, wild West. Dietary supplements really are regulated. Ask any reputable on the radar manufacturer. They feel more than adequately supervised. In fact, they can even be vindictive. I know one owner who got a little cutesy with an FDA inspector and soon had visits from every local authority, the IRS, OSHA (safety), and even Alcohol Tobacco and Firearms (because he used a bit of vodka as a preservative in a sinus spray.)

As I pointed out in last week’s blog covering Consumers Report’s confessed bias against supplements, it would be patently ridiculous to regulate these food-like substances in the same way we do drugs. A person doesn’t need a prescription to buy a bulb of garlic, so why should we need one to buy garlic that someone has dried and put in a capsule? Pharmaceutical-type regulation would, in practical effect, take supplements off the market. Below is some basic information taken from a press release by the Natural Products Association. (I was once NPA’s president when it had another name.) These facts may help balance the scare tactics so often publicized.

• Supplements are regulated by the Food and Drug Administration (FDA) as a special category of food. There are legal requirements for facility registration and the law requires use of good manufacturing practices (cGMPs) for sanitation and quality control. In addition to that, our Texas Department of Health also keeps a close eye on manufacturers and I believe that is true in most other states.
• Dietary supplements have a fantastic safety record, especially when compared to medication and incidence of hospitalization from illness due to problems in the food supply. As we know, food can sometimes be contaminated. Periodically everything from spinach to peanut butter and ice cream are in the news. The safety record of supplements is much better than food in part because much of the process is automated and the ingredients are often dry and therefore less subject to spoiling.
• Supplements are currently the only food commodity to require mandatory Serious Adverse Event Reporting (SAERs). Curiously, those requirements are the same or, in some cases, even more involved than those for potentially dangerous pharmaceuticals. The large numbers of complaints quoted by Consumer Reports is based on a mathematical estimate not an actual number of SAERs from the FDA. And, as I mentioned last week, it is highly likely that in most cases the supplement was just an innocent bystander to an event caused by another factor. That said, it is possible to use supplements inappropriately and next week I will offer some cautions.

• The FDA also has strict requirements for how supplements are labeled. Companies get in very big trouble if the ingredient or dose in a pill is different than what is stated on the label. The FDA also tightly limits what a manufacturer can say about the supplement’s benefit. (That is why labels usually seem so frustratingly vague.) The Federal Trade Commission (FTC) has primary responsibility for regulating the advertising of supplements and sets a high bar for proof of claims.
• If an ingredient has not been in commercial use before, there are very tough requirements for marketing it.

As I said, dietary supplements are regulated. New regulations are not needed, but the existing rules could surely be enforced more uniformly. For years, the NPA has called for full implementation of the cGMP regulations and has pushed for the FDA to be given more funding so that they could hire enough inspectors. The NPA has also fully supported government efforts to crack down on illegal drugs being marketed as dietary supplements.

So what is the big stink about? Most of us in the nutrition world think that the underlying problem is the amount of money being made in pharmaceuticals and the FDA’s close ties to that industry. The very idea that people can stay healthy or heal using non-patentable supplements is unsettling to the establishment.

Of course, there are shady operators on the fringe of any industry. For example, what could be more tightly regulated than the distillers of alcoholic beverages? And yet individuals still sell moonshine. The vast majority of supplements carried in responsible stores are safe and appropriately labeled. Next week I’ll discuss why supplements are being used more frequently even in mainstream medicine. I’ll also tell which ones to stay away from.