Tod Cooperman, president, ConsumerLab.com, White Plains, NY, recently sat down with Nutraceuticals World to discuss a recent Government Reform Committee Hearing, as well as the state of the dietary supplement industry.

You recently attended a Government Reform Committee Meeting on Supplements. What are your general thoughts about what was accomplished?

Unfortunately, the hearing left a lot to be desired. Many were wondering at the conclusion what the purpose of the hearing was. On one hand, it was clear there was concern regarding adverse event reporting for dietary supplements and getting FDA to acknowledge that this is an issue. But it seems the FDA representatives did not feel there was an issue in this regard.

In the meeting, both FDA and FTC re-stated the programs they have in place to regulate supplements. The FTC was a little more positive with regard to some of the actions it has been taking in the context of enforcement.

Not a lot of representatives attended the full meeting; a lot of them were stepping in and out to attend other meetings. I believe some important votes were going on that day, which seemed to take away from our hearing. At any given time there were not more than three Congressmen on average in attendance.

Besides the government agencies, what other groups testified at the hearing?

The other groups were ConsumerLab.com, United States Pharmacopeia (USP), the National Sanitation Foundation (NSF), and Consumers Union. Each group re-stated its programs and discussed various issues in the marketplace. We touched on the fact that one out of four products on the market has a quality problem and it is difficult for consumers to know about these issues.

Can you be more specific?

Good Manufacturing Practices (GMPs) for dietary supplements will help clean up the industry but not to the extent that everyone believes they will. This is because those standards are being watered down. The GMPs will help assure more consistency from batch to batch, but that doesn’t necessarily guarantee a good product. The GMPs don’t define quality standards for specific products. For example, if you are manufacturing a ginkgo product, there are no standards that define a “good” ginkgo product.

A lot of manufacturers do not regularly check the quality of their ingredients and often rely on unverified certificates of analysis. What can be done is very simple: employ more routine analyses of these ingredients in house. The GMPs could address these issues but it is not clear right now if they are going to.

Another problem is few manufacturers withdraw products from the market even when problems have been identified. Manufacturers are also not required to meet defined standards of ingredient quality, identity or dosage. The Federal government hasn’t really established standards of purity to the point where we are still finding things like lead in the supplements we analyze. Currently these standards are established on a state-by-state basis, which is where Proposition 65 in California comes in.

There is also the issue of FDA enforcement. Right now we see very little proactive monitoring of product quality. And there is little follow up when adverse events surface unless they are life threatening.

Better uniformity in labeling would also help consumers compare apples to apples when they are looking at ingredients. For example, if you are dealing with glucosamine there are some differences between glucosamine sulfate and glucosamine hydrochloride, for example. The active amount of glucosamine in a glucosamine sulfate product is only 70% of that in a glucosamine hydrochloride product due to the differences in weight. But frequently consumers do not know about these subtle differences.

Warning labels are generally voluntary and we think they could be better. Obviously there are times when it is perfectly acceptable to exceed a RDA or upper tolerable intake level (UL), but consumers should know when they are exceeding those levels. Furthermore, the daily values for nutrients have not been updated since 1968. The current levels in supplements are based on old research. But manufacturers are resistant to doing the right thing by manufacturing the daily values recommended by the National Academies because then it would look like their formulations are under 100%.

Lastly, the quality of supplements tested in government-funded clinical trials should be more rigorously assessed before all of this time and money is spent investigating them. More thought really needs to be put into the design of the studies. The government is studying these products and I think that is great, but we need to make sure that they yield useful information.

Can you find any silver linings in the supplement industry today?

I don’t think the situation with supplements is as bleak as it seems. We are coming through a period right now where the majority of recent, high profile studies have been perceived to yield negative outcomes. But there have been several reports of positive aspects of these studies as well. I think the industry sets itself up for some of these disappointments because of its tendency to tout weak associations between an ingredient and a disease and try to make it sound like it is a “cause and effect” situation.

The reality is, a majority of products on the market today are fine. That said, we take the position that consumers still need to be aware of the products they buy because there aren’t as many safeguards in place as in other industries, whether it’s warning labels, GMPs or adverse event reporting.

So if we successfully addressed some of these issues, would life be any easier for dietary supplements?

Sure.

Do you consider ConsumerLab.com a friend or foe of dietary supplements?

ConsumerLab.com is a friend of the consumer first and foremost. That is where our allegiance always has to be. We feel we are actually giving consumers more confidence in supplements by providing the service that we do.