I knew from the outset Day 3 was going to be interesting. In my mind, I’ve named it “The Day O’Spin.” You’ll see why. . . .

We met at the Russell Senate Office building to hear from Senator Orrin Hatch (R-Utah) who was the sponsor of the Dietary Supplement Health and Education Act (DSHEA) which was passed and signed into law in 1994. DSHEA was intended to “regulate” the supplement industry. Sen. Hatch strongly believes that DSHEA provides the FDA the all of the means and tools it needs to appropriately regulate supplements, but the FDA does not have enough money do enforce the regulations. We thought we would only have 20 minutes of his time, but he stayed for about 45. He also spoke about the Adverse Event Reporting (AER) which was passed after ephedra was withdrawn from the market. It turns out one manufacturer of ephedra-containing products had 1,500 reports of adverse events which were not reported to the FDA. Oops! Now, adverse events (for drugs or supplements) have to be reported to the FDA. Regardless of what you think of Sen. Hatch or DSHEA, he was an engaging speaker.

Next up was Donna Porter, PhD from the Congressional Research Service (CRS). Donna was a truly enlightening speaker. The CRS provides information to the Congress on all sorts of issues – basically providing historical and other contexts for issues. When a Congressperson or his/her staff has a question, they call the CRS for information. Her area is nutrition – which means she was involved with DSHEA and the AER acts were being drafted and passed. She echoed one aspect of Sen. Hatch – that the FDA does not have the funding to implement the regulations in DSHEA. However, she added that some of the aspects of DSHEA would be difficult to implement. Her talk was incredibly interesting.

Next, we moved to the Wilbur J. Cohen Building (which also houses Voice of America) for panel discussions with representatives from the supplement industry and from consumer groups. The supplement industry was represented by Steven Mister from the Council for Responsible Nutrition, Daniel Fabricant, PhD from the Natural Products Association, and by Steven Dentali, PhD from the American Herbal Products Association. These are all trade groups for the supplement industry. I was keeping an open mind and was pleasantly surprised to learn that these groups do “self regulate” their members. They require their members have Good Manufacturing Processes (GMPs) in place and actually do test member companies’ off-the-shelf products for quality and purity. They believe that the current regulations and enforcement are adequate. However, one of the panel members said that he did not believe that randomized control trials are appropriate for supplements. WHAT?!?!?!? His justification was that nutrients work in many ways on many systems and that creating a control group is impossible. Again, WHAT?!?!?!? Honestly, there isn’t a lot other than that to report from this group. They were all trying to spin their messages to show that supplement companies are good, produce products that are pure and not contaminated, care about the consumer, etc. While I think some companies are, I also think there are a lot of supplement companies who are not. And, how can those “rogue” companies who are producing trash supplements be “regulated” by industry groups if they are not members of the groups.

Finally, were the consumer oriented groups. These groups were represented by David Schardt from the Center for Science in the Public Interest and Peter Lurie from the Public Citizen’s Health Research Group. Unfortunately, Rob Stein from the Washington Post was unable to attend. You can probably guess the line these speakers took – supplements need to be tightly regulated for efficacy, purity, etc. One panelist said that DSHEA keeps the FDA from more tightly regulating supplements (which is true), and that the biggest problems is that dietary supplements are a consumer rip-off. (Did I say spin?) Basically, they want more and tighter regulation of the dietary supplement industry.

After the last panel, we went to the National Museum of the American Indian for lunch. If you have a chance, go! The cafeteria has representative native American food from different parts of the country. I had buffalo chili, fry bread, and a salad made from fiddle fern, asparagus and corn.

Key learnings from today:

• Consider the source of information. People are going to try to spin the information to meet their goals including carefully using research to “prove” their point.
• Everyone says the FDA needs more money for enforcement.
• Issues relating to dietary supplements are not black and white. There is a lot of gray area.
• I do think the supplement industry can be helpful in working with congress and the FDA because they work with supplements every day.
• There are responsible companies in the dietary supplement industry. However, there are a lot of irresponsible companies, too.
• Given the confusion of consumers in the US regarding dietary supplements, those in other countries are probably even more confused. And, a lot of other countries do not have consumer advocates trying to keep the dietary supplement industry in check.

The second day of the ODS Practicum proved to be just as busy as the first. Again, I had an early breakfast at the Tastee Diner. My hotel is about a ten minute walk to the NIH campus which is a nice way to start the day.

Today’s morning agenda was one that really caught my eye. We started off with Meghan Murphy, PhD discussing how a drug is brought to market. Then, Debrah Miller, PhD (and the Director of Nutrition for Hershey) talked about bringing a food to market. Finally, Anthony Lamada, MS spoke about bringing a supplement to market. Comparing and contrasting these three things was quite interesting and, honestly, confusing. There is a lot of gray. If a manufacturer does not like the rules of one type, they may be able to change to another. Stevia is a great example. They didn’t have the research initially to have it declared a food additive, but they could have it declared a nutritional supplement immediately! Since then, enough scientific evidence has been presented to have it labeled as a food additive. Given the variety of people attending the practicum, there was good discussion about, for example, using dried berries as a medical treatment – is it a food or a drug? This is just one example we discussed.

The last session was given by Bill Gurley, PhD who discussed interactions between supplements and drugs. He talked about several interactions I was aware of, but also quite a few I was not. Bill focuses on interactions between drugs and herbals. Again, lots of great information.

Over lunch we got another overview of the NIH and a preview of the campus tour scheduled for later in the day.

The afternoon sessions were not high on my list, but yet again, I learned a lot. We started with Lawrence Friedman, MD talking about efficacy and effectiveness and how to measure them in research settings. He was followed by Elizabeth Yetley, PhD who talked about safety. Finally, Joseph Betz, PhD spoke on identity and quality. Once again, the grouping of these topics proved to be an excellent design. Each laid a foundation and then built upon it and on the information provided previously. I learned that there are quite a few differences in designing studies to test efficacy vs. effectiveness. There was more information about safety and the facets of safety than I had considered. Finally, the lecture on identity and quality added on to the information provided earlier today and yesterday.

The highlight of the day was a tour of the NIH campus including the Clinical Center and the National Library of Medicine. The NIH campus in Bethesda has over 80 building on 322 acres and over 18,000 employees just on this campus. It is a beautiful campus. The Clinical Center is the hospital on the NIH campus and has 320 (I think) beds. In order to use the Clinical Center, patients have to be enrolled in NIH funded studies. There is also a “hotel” onsite and a facility similar to the Ronald McDonald House for children and their families. The building is beautiful. We visited several units including the metabolic unit. I have pictures I’ll post when I get home. We also got to see one section of labs used for bench research.

Next, we went to the National Library of Medicine. There are some great resources available. I’ll post more links when I return home and have more time. Here’s a link to “Turning the Pages” which lets you page through a high quality virtual copy of some of the seminal works of science and medicine. We also got to go into the computing area where they have four screens showing: number of people using the Library databases (PubMed/Medline for example) at one time, top 100 search terms, where the library is being accessed from, and I don’t remember the last one. It was interesting to see what people were researching. If you are in Bethesda, I’d highly recommend visiting. Yes, you can go to the National Library of Medicine. We also toured the exhibit called “Against the Odds” in the library which was subtitled “Making a Difference in Global Health.” It was an amazing exhibit and covered interventions all over the world to improve the health of people everywhere. It covered topics like food supply, rehydration, public health clinics, AIDS, landmines, etc. When you have a few minutes, I’d recommend taking a look at it.

Key learnings from today:

• Manufacturers can play around with what they want to call their product which changes how the product is regulated by the FDA.
• Again, the FDA’s hands are tied by the laws written and passed by the congress and signed by the president.
• I knew bringing a drug to market was time consuming and expensive, but I got reminded of just how time consuming and expensive it is.
• There is a lot of confusion about how to classify products – particularly between food and dietary supplement – among the attendees. If we’re confused, then the manufacturers and public are definitely confused.
• My understanding of efficacy, effectiveness and safety have been deepened. There are a lot of things to think about regarding these concepts, how they are researched and measured.
• Again, enforcement is so limited it is easy for manufacturers to do what they want with little chance of being fined. Even if they are fined, the fines are a slap on the wrist often only taking a tiny amount of the profits gained from sales of the product.

Tomorrow we head to DC to have a panel discussion with Senator Orrin Hatch who was key in the development and passing of DSHEA into law. The other panel member is from the Congressional Research Service. Then, we have a panel session with representatives from the dietary supplement industry followed by a panel from the consumer groups (including CSPI) and media. Tomorrow should be a highlight of the practicum!

I had high expectations prior to attending the National Institutes of Health Office of Dietary Supplements (ODS) Supplement Practicum. My expectations have already been exceeded.

The day started off with an early alarm (how early does it get light here? it was already full light when my alarm went off at 5:30). I got ready and headed to the Tastee Diner for breakfast. I always like to find local diners/cafes for breakfast, and I found a winner. I pretended to read the paper and just listened to the “show” put on by the locals at the counter. What a hoot! Finished breakfast and got back to the hotel to get my things and take the shuttle to the NIH campus.

Getting on the campus was quite the process. We all had to get out of the van, go through a metal detector, open all our bags (and every pocket in each bag), provide the slip from the security guard and picture ID to the van driver, have the van searched, get our badges back from the van driver with our passes for the day. Whew! The campus is HUGE and beautiful. One of the other ladies in the van was also going to the practicum.

Made it to the correct building, got checked in and received a HUGE binder of information. I’m going to have to find a UPS/FedEx store to ship it back it is so large. Then, got settled in for the day.

We started with a welcome session. Paul Coates, PhD, the Director of the ODS, spoke after the housekeeping announcements were made. He gave an overview of the ODS, how it fits into the NIH, etc. Then, we heard from Mary Frances Picciano, PhD, about who takes dietary supplements. She provided some great information on the breakdown of the population who takes supplements – over 50% of the US population takes dietary supplements. Next up was Johanna Dwyer, DSc, RD. Johanna spoke about why people take supplements – their motivation. It brought to the forefront the idea that different people have different reasons/motivations for taking dietary supplements as well as one person may have different reasons/motivations for each supplement. It is critical to ask and understand why people take each supplement they take. She also reviewed several of the collection methods – surveys, focus groups, etc – and the pros and cons of each method. The last speaker before lunch was Regan Bailey, PhD, RD, LDN. Regan spoke about measuring food and supplement intakes. Her presentation included a ton of things I hadn’t thought about with regard to collecting food and dietary supplement information from consumers. She also provided information on the National Cancer Institutes FREE 24-hour recall program.

The morning flew. Yeah, I know the topics do not necessarily sound thrilling, but the speakers and presentations made them more interesting than I thought they could be. Also, each presentation is 45 minutes with 15 minutes for questions. After two presentations, we get a break. This just about fits my attention span.

Lunch was in the cafeteria in the building. The cafeteria leaves a lot to be desired in the selection department. Oh well, we may try another tomorrow.

Looking at the afternoon agenda, I wasn’t too thrilled and thought it would be a snooze-fest. The overall topic was “It’s the Law: Rules and Regulations.” See my point?

Well, the first tspeaker was William Schultez, JD who was involved in the writing of the Dietary Supplement Health and Education Act (DSHEA) among other food/nutrition laws. He provided a background of what life was like before DSHEA and what lead to the development of DSHEA. The next speaker was Vasilios Frankos, PhD from the FDA. He explained the FDA’s role in dietary supplement monitoring and regulation. Next up was Michelle Rusk, JD from the FTC. She explained the role of the FTC and how the FTC and FDA work together. Finally, Paul Thomas, EdD, RD. Paul spoke about supplement labels and claims. Now, this session was at 4PM, and although I’d stayed engaged in the prior presentations (surprise!), I wasn’t sure about this one. Paul did an amazing job explaining supplement labeling and claims.

The main things I learned today:

• The ODS cannot directly fund research (they are not an institute) but can fund research in conjunction with institutes.
• How many people take supplements and the top supplements taken.
• Different ways supplement usage is researched as well as some of the pros/cons of each.
• Talk with people about what they are taking and why (not just “why” but what is their motivation.
• The FDA really has its hands tied due to funding and the ways the laws are written. The FDA gets blamed for a lot of things with dietary supplement regulation when it really isn’t their fault – the problem is how the laws are written.
• The FTC has the “teeth” to go after compnies and people. However, they are also constrained by funds and have to target key types of supplements. Also, the FTC is staffed by lawyers, so they rely on the FDA for a lot of the science behind the claims.
• Supplement labels are vague for everyone – including those regulating them. For example, there isn’t a good definition of a “medical food.”

If today is any indication of what the remaining 4 1/2 days will hold, I can’t wait! Tomorrow we get to talk about how foods, drugs and supplements are brought to market (a presentation for each). There will also be a talk about the interactions between supplements and drugs. In the afternoon we get into efficacy and effectiveness, safety, identity and quality. Then, we get a tour of the NIH Clinical Center! I think I’m wearing my running shoes.

The ODS Practicum is currently open to those in academia. However, Paul (the Director of the ODS) spoke about having other such meetings for groups including Registered Dietitians. I hope they do so in the future.