Answer to that question has changed over time. Initially, dietary supplements were thought to be things like vitamins and minerals only, but the DSHEA altered the definition. In essence, this legislation, which was sponsored by Utah’s Senator Orin Hatch, defined a dietary supplement to be…Broad class of consumer products that are sold with the intention of somehow enhancing health.
For consumer and family health, when we are purchasing these products that are to enhance our health, are these products safe and effective?Unless gov. steps in and makes sure the info being communicated is accurate and the item being sold is safe. Potential of being harmed by unscrupulous manufacturers. Level playing field so consumers have same info and can make informed purchases that they feel will help their health. Growing in terms of sales and profitability over time.
Contrast that to the regulatory budgets of the FDA and the FTC, which are the two agencies charged with regulating this market, the entire budget, if you may recall for the FDA is just a little over $3 billion, and the annual budget for the FTC is just $256 million. So, this is an industry like the prescription drug industry, that far and away exceeds the regulatory arm that is in place to ensure that it produces a safe product. This is a very big market. These are people who are taking vitamins, herbal remedies, weight loss products, muscle building products, hair loss products,
This chart was put together by the General Accounting Office and it shows what has happened to sales of dietary supplements over time, and what you can see is that between 1997 and 2007, sales of dietary supplements in the U.S. have had an upward trend. The have increased by about $8 billion.
This graph, even though it is a little bit old, was the only one that I was able to find that actually shows the gender breakdown in terms of who takes dietary supplements, and it also gives a breakdown by race. What you see is that women are more likely to be taking dietary supplements than men, and white non-hispanics are more likely to be taking dietary supplements than African Americans and Latinos.
A 2002 study that was published in the Journal of American Medical Association used data to analyze why people were taking dietary supplements, and they classified them into two different groups, those that were taking vitamins and minerals, and those that were taking herbals or supplements. In most cases as you can see from this table here, individuals reported that they were taking It because they wanted to ensure good health. In some cases, they are taking it for specific reasons like to deal with arthritis problems or memory improvement,
May lead some to move away from traditional health care options to dietary supplements, in the hope that they are going to treat a chronic condition, or treat an ailment at a lower cost than they would if they had to go into a traditional health care system. For those who think that the cost of health insurance it too great, or are uninsured, they may see the dietary supplements market as a viable alternative or substitute for traditional health care. Some sentiment expressed in surveys and polls that there is … and therefore people are growing more skeptical over traditional types of health care treatments, and turning to more natural health care alternatives.
Given that this market is a very large market, and given there is a problem with consumers having much less information about what they are purchasing than the manufacturers, this is a market where there has been general agreement that there is the need for government to step in and regulate the flow of information so that consumers have the same info that manufacturers have about the efficacy and safety of the products that they are purchasing. Historically, there has been some tension between the FDA and the FTC over who has regulatory authority. Currently, the regulatory authority is actually split between these two agencies. The FDA regulates their labeling, regulates them under a different set of rules than food and drug products. Because of the Dietary Supplement Health and Education Act of 1994, the special rules that the FDA uses state that the manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed, and the FDA is responsible for taking action against any unsafe dietary supplement product after it has reached the market. Manufacturers have to make sure that the product label info is truthful and not misleading, and the FDA’s post market responsibilities include monitoring the safety of the dietary supplement and validating that the product information such as the labeling and the inserts is accurate. In contrast, the FTC is primarily responsible for ensuring that claims in advertisements regarding dietary supplements are truthful, not misleading and can be substantiated. So, you have two different regulatory branches that are involved with regulated dietary supplements. The FDA regulates the claims that are made on the package per say, and the FTC regulates the claims that are made in advertisements.
Implications for what the FDA does and doesn’t do with respect to insuring that the labels are accurate and reflect what the dietary supplement actually does. Don’t need to show any data that says here we’ve given this supplement to one group and not to another group, and look how their blood pressure has been lowered, or their hair has grown thicker, etc.All of these stipulations were made as part of the Dietary Supplement Health and Education Act of 1994, so this was a landmark legislation with the way that regulation occurred in this particular market from the perspective of the FDA.
First, you should note that they types of claims that can be made on the labels of dietary supplements differ from those that can be made on drugs. Drugs manufacturers can claim that their product will either diagnose, cure, mitigate, treat, or even prevent a disease. These types of claims cannot be legally made by dietary supplements. What dietary supplements can claim on their packaging is:That if a product has 100% of the RDA for vitamin A, they can list that on their packaging label, and the FDA has the capability to look at these claims both the health claims and the nutrient claims to see whether or not they are accurate. Structure or function claims do not have to have any FDA approval, but the manufacturer must supply the FDA with the text of the claim within 30 days of putting the product on the market. Product labels containing such claims also include a disclaimer that reads quote, “This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent disease.” So, in essence, through the structure/function claim, the manufacturers of dietary supplements are given a lot of leeway about the types of claims that they can make on product labels, without the FDA being able to intervene and call them on that claim.
So, one may ask the question, well, how frequently are there adverse events associated with the use of dietary supplement products that may be related to their safety or efficacy. Historically, it is hard to answer that question because it wasn’t until an amendment to the Dietary Supplement and Non-prescription consumer drug protection act of 2006, that dietary supplement companies were required to report the adverse events associated with their products to the FDA. What you see on this graph, again, with data collected by the GAO, that voluntary reports that were characterized as serious, actually went down over time. Non serious reports stayed about the same, but beginning with 2008 when mandatory reporting was required, for all serious reports, you see that the number of serious reports goes up considerably, and you can see that they vary quite a bit in terms of what the consequences were for the consumer, but you have as of 2008, in essence, about 850 dietary supplement products that generated adverse event reports during that calendar year. Now, that is about 850 out of 29,000, but that is still a sizeable number.
This next table shows a breakdown of the types of products that were associated with adverse events reports, and what you see is that in most cases they were combination products that had both herbal and vitamins in them, or proteins and vitamins, or some type of combination of those. But then if you go to single source type of dietary supplements, you see that vitamins accounted for a large fraction of the serious adverse events, followed by minerals, and then with quite a bit lower percentages, the other types of dietary supplements.
And its regulatory authority with respect to dietary supplements. While the GAO said that the FDA was doing some good things, they strongly urged the Food and Drug Administration to request …Rather than have the manufacturers basically be able to come up with new dietary supplements on their own, they thought that the FDA should be involved from the beginning in terms of providing some guidance about what types of things could be dietary supplements and what should not be. So if you have a food that has been fortified with vitamins, should it be considered a dietary supplement or should it be considered a food. The answer to that question is then going to provide guidance with respect to how that product is regulated by the FDA, so getting clarification on those boundaries is very important to getting accurate information to consumers about whether you are talking about a food, a dietary supplement, or some combination of the two. That most consumers were ill informed about what dietary supplements are, what they can do and what they can’t do, and how safe they are. So consumer understanding of both safety and efficacy were of concern to the General Accountability Office, and they thought that the FDA should be doing a better job on that front.
Largely because their info comes from manufacturers advertising.
Dietary Supplements<br />The Role of Government in Protecting/Enhancing Consumer Welfare<br />
What is a dietary or nutritional supplement?<br /><ul><li>Dietary Supplement Health and Education Act (DSHEA) of 1994 definition:</li></ul>A dietary supplement is a product taken by mouth that contains a “dietary ingredient” intended to supplement the diet. E.g., <br />Vitamins<br />Minerals<br />Herbs or other botanicals<br />Amino acids<br />Substances such as enzymes and metabolites<br />Weight loss products<br />
Why do we care about dietary/nutritional supplements?<br />Same issues that were raised with prescription drugs<br />Safety: Ingredients are what they claim to be?<br />Effectiveness: Ingredients do what they claim to do?<br />Implies asymmetry of information between consumers and manufacturers<br />Very large market<br />
What does the dietary supplement market look like?<br />$23 billion per year industry in 2008<br />29,000 dietary supplement products on the market (up from 25,000 in 1993)<br />More than 150 million Americans take dietary supplements annually<br />
Why is the dietary supplement market growing?<br />Rising health care costs<br />Increasing costs of health insurance (and growing numbers of uninsured)<br />Growing distrust of the quality of the mainstream health care system<br />
Who should have regulatory authority over dietary supplements?<br />FDA<br />FTC<br />
FDA regulates supplements as its own category. This implies…<br />Research studies on people to prove a supplement’s safety are NOT required<br />Manufacturer does NOT have to prove the supplement is effective<br />Manufacturer does NOT have to prove the supplement’s quality<br />FDA does NOT analyze the content<br />Manufacturer must only meet the requirements of the FDA’s good manufacturing practices<br />
Label Claims Regulated by FDA<br />Health claims describe a relationship between a food, food component, or dietary supplement ingredient, and reducing risk of disease or health-related condition<br />Nutrient content claims describe the relative amount of a nutrient or dietary substance in a product<br />A structure/function claim is a statement describing how a product many affect the organs or systems of the body and it can not mention any specific disease<br />
GAO 2009 Report: FDA should request the authority to…<br />Issue guidance on new dietary ingredients<br />Clarify the boundaries between dietary supplements and foods with supplemental ingredients<br />Take steps to improve consumer understanding of dietary supplements<br />
Reviewing…<br />Dietary supplement market is large & is growing larger each year<br />Consumers have limited information about effectiveness and safety, disadvantage for them in the dietary supplement market<br />Justification for regulatory intervention by FDA<br />FDA’s regulatory actions are constrained by Dietary Supplement Health and Education Act of 1994<br />Regulatory actions limited to a focus on label and package information and the reporting of adverse events<br />Consumers still have little knowledge regarding dietary supplements and what knowledge they do have is questionable. Why?<br />