Mister Mister and Other Hearing Hilarity

The funniest thing in yesterdays hearing was how much the Senators seemed to enjoy saying Mr. Mister over and over. And over. Not until late in the hearing did Sen. Corker finally say he felt silly saying that and would use Mr. Steve instead. Yet, still the others persisted with their 80s nods.

Beyond that, not much was funny (unless you take funny to mean curious), especially Al Frankens inevitable attempt at humor during his brief turn as inquirer. One interesting comment Franken made was when the Q&A touched on possible interactions between dietary supplement ingredients and either prescription or OTC drugs. Sure, he was pulling an example from the top of his head, but when he said, If I drink grapefruit juice it can interfere with statins, I think, he made an interesting connection between supplements and foods. Consumers turn to dietary methods of staying healthy. They may drink more orange juice hoping to boost the immune system or stave off a cold, or they may take vitamin C. They might eat more fish to get a high amount of omega-3 fatty acids for heart health, or they might just take a supplement. Yet, somehow supplements are paraded as the dangerous of this triad. With relatively few serious adverse events for supplements reported to FDA since the law for supplements and OTC went into effect, it amazes supplements have this back-alley-dangerous reputation among a sector of Congressmen and watchdog groups, when OTCs and prescription drugs continue to be openly abused by a large part of the population, to great ill effect. This is not to say the smaller of dangers should be ignored, just that the proper perspective should be applied.

Speaking of AERs, Charles Bell, Consumer Union, recommended expanded regulations to make submission of all adverse event reports (AERs) mandatory for supplement makers, saying this would give FDA more information to gauge emerging problems and trends. This would bring supplements in line with drugs and OTC, he contended. Of course, Mister reminded him OTC AERs are regulated unfder the same law as supplements. This tells me Bell was picking on supplements. Also,Bell didnt appear satisfied when: 1. Sen. Hatch advised the current SAER regulation for supplements and OTC products requires manufacturers to maintain records of all AERs for a period of several years (to be turned over to FDA upon request); and 2. Mister reported submitting an AER to FDA for every perceived association would be a burden on industry and FDA, which has said it does not have the resources to handle such an expansion of AE reporting.

Back to Frankens topic of interactions: foods, supplements and drugs all contain bioactive substances. No matter the source, these compounds can all possibly interact with one another. I appreciate the suggestions for providing more information on contraindications, and I think providing as much information as possible for potential known interactions is a good recommendation for all categories of products. How to best offer such information is a longer discussion.

In the end, many lines of questioning ended up at the subject of FDA. Sen. Kohl seemed to think there was some magic trick the industry and its associations could pull to miraculously get fringe companies to stop breaking the law. Mister tried to explain that CRN and the like are trade groups who have a great influence over its members and the responsible part of the industry. They cant break down doors and force companies to stop manufacturing or marketing illegal products and claims. The most they can do is educate on the laws, encourage and urge responsible practices, and report violators to the FDA and FTC. We are not the police at some point, we need the enforcement agencies.

I would add even if the responsible industry banded together to blacklist companies making illegal claims or peddling adulterated or subpar product, those companies can find partners in other fringe companies and source materials from other countries. People tend to break the law when they dont think they will get caught. This is an enforcement issue.

Also, as with foods, there are thousands of companies and marketers involved. To expect there to be no criminals among them is unrealistic. There have problems in the food industry with bad actors, and there have been plenty of underground pharmaceutical operations in recent decades. No one blames the pharma or food industries for these outliers. The Feds take enforcement action, closing these operations down and/or punishing them accordingly. The supplement industry needs this same enforcement attention.

The two product displayed by GAOs Gregory Kutz are illegal for their labeling and claims. As Mister suggested, these should be referred to FDA. Kohl kept coming back to these two products as though they represent the entire industry, as if every other supplement product is similarly in violation. I like how the point was made, by Corkers prompting Mister, I believe, that these two products selected were pretty much unknown in the supplement industry, showing these are the exception, not the rule. When Kohl asked Kutz if GAO referred these products and the marketers they found using disease claims to FDA, Kutz confirmed the violations were sent to FDA, but conceded FDA didnt offer definitive action, if any, they would take against any of these violators. When also asked if FDA took issue with the trace amounts of heavy metals found in supplements GAO tested, Kutz said the agency found no threat to Americans health from such trace amounts.

After all the back and forth of this multi-witness part one of the hearing, FDAs Sharfstein all but admitted implementation delays and enforcement obstacles in his testimony and responses to the Senators questioning. He argued FDA is committed to fully implementing DSHEA and is soon to come out NDI guidance and plans to step up GMP inspections.

Add FDAs promises and Misters report of all the industry has and plans to do to self-regulate, to the new bill from Sens. Hatch and Harkin the Dietary Supplement Full Implementation and Enforcement Act of 2010and you have a pretty aggressive campaign to make supplements safer, more responsibly marketed and sold, and well-regulated, while still offering Americans the access to dietary supplements they so often request.