FDA Stakeholder Meeting on Dietary Supplements, June 8, 1999
The meeting was chaired by Joseph A. Levitt, Director, Center for Food Safety and Applied Nutrition. He introduced the various topics to be discussed as:
Boundaries, Claims, Good Manufacturing Practices (GMP), Adverse Event Reporting (AER), Laboratory capability, Research needs, Enforcement and Resource needs.
The meeting consisted of various ‘expert’ panels ranging from Trade Associations to industry, attorneys for individual companies, nutrition professionals, neutraceutical company representatives and consumer groups.
Safety was an often repeated issue and concern was expressed over methods to report adverse effects. The system currently in place, for pharmaceutical products, at FDA has not worked all that well in the past. Many speakers mentioned ways to support a scientific basis for claims. It was suggested that the monographs created by the United States Pharmacopeia be accepted. The USP is a non-governmental body that has issued standards in the past.
In their statement they said they intend to establish standards for major nonbotanical dietary supplements including glucosamine sulfate, chondroitin sulfate, coenzyme Q-10 and others so that the same levels of protection that is afforded through USP botanical-based dietary supplements standards will be available.
They encouraged FDA to work with them to help develop these standards. It is believed that such standards will ensure purity, potency, quality and safety. The speaker from USP mentioned a concern about herbs and contamination by pesticides.
A speaker from the Society for Nutrition Education suggested that consumer research be conducted to determine how consumers view label advertising and marketing of products.
A speaker from the Institute for Food Technology felt that a distinction should be made between food and supplements. She mentioned that some foods already have herbs added and suggested that FDA issue a Talk Paper on how ingredients could be handled. She also suggested that FDA finalize information on rules already issued.
Consumer speakers stressed labeling as an important issue: emphasizing clarity and readability. The speaker from AARP was concerned that the size be appropriate. He also mentioned the fact that he had just found out that garlic could thin the blood and was wondering what the interactions would be with pharmaceutical blood thinners. (Ann’s NOTE: Perhaps doctors would be able to prescribe reduced dosages of drugs given their legacy of “unwanted” or side effects in favor of part garlic, part pharmaceutical).
Speakers from the neutraceutical area said their products focused on prevention of disease. It was also stated that price is driving the marketplace now not research. One speaker suggested a type of Orphan Drug act in which companies could get back an investment in research. I.e. temporary exclusivity.
One attorney suggested that FDA hold many local meetings allowing small manufacturers access to FDA expertise directly. Charging a user fee was suggested which would help pay for FDA efforts (it was universally acknowledged that FDA funds are very limited).
FDA panelists stated that they were committed to speaking with all segments of the community and would include them in advisory groups.
Ann Fonfa of The Annie Appleseed Project had a chance to speak at the end of the day. On June 7, Ann had attended a one-day meeting at FDA to discuss standards for approval of oncologic drugs. She brought some of that perspective and the anger it generated to this meeting-please see the report on the June 7, 1999 ODAC Advisory committee.
A summary of her statement follows:
I echo the safety concerns that were mentioned here today and support the need for good manufacturing practices that will yield products that contain what their label says. As a cancer patient, I request immediate information on product efficacy. This is very important to us as the standards for drug development have yielded extremely toxic and relatively ineffective drugs. Do not follow that path. We need to know what works among the dietary supplements. We need things to reduce the unwanted effects of what we are given. We need products that will support our immune function. And if a cancer treatment exists in the botanical world, we want to know.
I agree with other speakers who mentioned that quite a bit of research exists about dietary supplements. Please don’t limit anything to single elements when it has become clear that combinations is how people are actually using supplements. None of us take one product only. And we know that vitamins act in concert.
The use of supplements sends a message to pharmaceutical companies that consumers are concerned about unwanted effects from drugs. Yes we are concerned about drug interactions but not just supplements with our drugs but drugs with other drugs.
We want our health care professionals to get involved and I deplore the fact that none were represented here today.
There was a discussion about the statement on labels that says FDA has not evaluated this product. I believe this statement causes cancer patients to start a regimen and then discontinue it as their fears rise. We need information on efficacy. We want to use the products that will work for us. Help us to discover what these are so that we do not waste our precious time and our money.
Boundaries, Claims, Good Manufacturing Practices (GMP), Adverse Event Reporting (AER), Laboratory capability, Research needs, Enforcement and Resource needs.
The meeting consisted of various ‘expert’ panels ranging from Trade Associations to industry, attorneys for individual companies, nutrition professionals, neutraceutical company representatives and consumer groups.
Safety was an often repeated issue and concern was expressed over methods to report adverse effects. The system currently in place, for pharmaceutical products, at FDA has not worked all that well in the past. Many speakers mentioned ways to support a scientific basis for claims. It was suggested that the monographs created by the United States Pharmacopeia be accepted. The USP is a non-governmental body that has issued standards in the past.
In their statement they said they intend to establish standards for major nonbotanical dietary supplements including glucosamine sulfate, chondroitin sulfate, coenzyme Q-10 and others so that the same levels of protection that is afforded through USP botanical-based dietary supplements standards will be available.
They encouraged FDA to work with them to help develop these standards. It is believed that such standards will ensure purity, potency, quality and safety. The speaker from USP mentioned a concern about herbs and contamination by pesticides.
A speaker from the Society for Nutrition Education suggested that consumer research be conducted to determine how consumers view label advertising and marketing of products.
A speaker from the Institute for Food Technology felt that a distinction should be made between food and supplements. She mentioned that some foods already have herbs added and suggested that FDA issue a Talk Paper on how ingredients could be handled. She also suggested that FDA finalize information on rules already issued.
Consumer speakers stressed labeling as an important issue: emphasizing clarity and readability. The speaker from AARP was concerned that the size be appropriate. He also mentioned the fact that he had just found out that garlic could thin the blood and was wondering what the interactions would be with pharmaceutical blood thinners. (Ann’s NOTE: Perhaps doctors would be able to prescribe reduced dosages of drugs given their legacy of “unwanted” or side effects in favor of part garlic, part pharmaceutical).
Speakers from the neutraceutical area said their products focused on prevention of disease. It was also stated that price is driving the marketplace now not research. One speaker suggested a type of Orphan Drug act in which companies could get back an investment in research. I.e. temporary exclusivity.
One attorney suggested that FDA hold many local meetings allowing small manufacturers access to FDA expertise directly. Charging a user fee was suggested which would help pay for FDA efforts (it was universally acknowledged that FDA funds are very limited).
FDA panelists stated that they were committed to speaking with all segments of the community and would include them in advisory groups.
Ann Fonfa of The Annie Appleseed Project had a chance to speak at the end of the day. On June 7, Ann had attended a one-day meeting at FDA to discuss standards for approval of oncologic drugs. She brought some of that perspective and the anger it generated to this meeting-please see the report on the June 7, 1999 ODAC Advisory committee.
A summary of her statement follows:
I echo the safety concerns that were mentioned here today and support the need for good manufacturing practices that will yield products that contain what their label says. As a cancer patient, I request immediate information on product efficacy. This is very important to us as the standards for drug development have yielded extremely toxic and relatively ineffective drugs. Do not follow that path. We need to know what works among the dietary supplements. We need things to reduce the unwanted effects of what we are given. We need products that will support our immune function. And if a cancer treatment exists in the botanical world, we want to know.
I agree with other speakers who mentioned that quite a bit of research exists about dietary supplements. Please don’t limit anything to single elements when it has become clear that combinations is how people are actually using supplements. None of us take one product only. And we know that vitamins act in concert.
The use of supplements sends a message to pharmaceutical companies that consumers are concerned about unwanted effects from drugs. Yes we are concerned about drug interactions but not just supplements with our drugs but drugs with other drugs.
We want our health care professionals to get involved and I deplore the fact that none were represented here today.
There was a discussion about the statement on labels that says FDA has not evaluated this product. I believe this statement causes cancer patients to start a regimen and then discontinue it as their fears rise. We need information on efficacy. We want to use the products that will work for us. Help us to discover what these are so that we do not waste our precious time and our money.
