The debate topic that I had to preside over was the regulation of drug and herbal supplements. Since I broke the debate into six parts Pros & Cons of labeling, claiming and advertising, this paper will follow the same format. I am going to go over in great detail the high points of both sides debate. Then the paper will conclude with my own analysis of the case, and which group I thought stated their case more strongly. Except for the fact I will talk about all of the pros and then discuss the cons of the issue.
PROS of Regulation
The debate began with Kerri stating her teams case as to why the government should step in and place stricter regulations on the entire supplement industry. I totally agree with her in that when people buy goods, the contents inside should be fully disclosed. Unfortunately for the consumer government intervention is not even allowed when the issue deals with dietary supplements. In fact the Dietary Supplement Health and Education Act of 1994 made the dietary supplements untouchable by the FDA. Of course this law does not apply to medical drugs, which fall under a completely different category. The only power granted to the FDA is to pull a product from the shelf due to false labeling, but not until it has already been publicly distributed.
Obviously since herbal and dietary supplements are drugs, the ingredients used in them must be disclosed on the bottle s label, but as we all know the print is microscopic and most people don t know what the stuff is. The companies manufacturing the supplements seem to be out to intentionally trick the consumer with some of their blatant actions. The pro group stated that many companies do not give 100% accurate figures regarding what is in each bottle. This accusation has been found to be true by both random scientist tests and further investigating by 20/20. One of the companies that was busted for false labeling explained the mishap as being a goof when the label for the bottle was made. I m sorry but I do not see how this can be described as simply a goof. Peoples lives and well-being are on the line when these products are being made so messing up in this magnitude is inexcusable and therefore should be watched over more closely.
I feel that although the companies are wrong for lying about the amounts of drugs in the product, but the most troubling issue deals with the disclosure or lack thereof of what makes up some pills. Kerri stated that numerous raw animal parts have been found in supplement bottles. That is very disturbing and also very unethical. Apparently some companies mention that animal parts are inside, but the technical name is used not the common term that most people would be able to comprehend. The example given was the use of orchis which technically means bulls testicles. I cannot speak for everyone but I would bet the farm that no one would take a certain pill full knowing that a bull s testicle is inside. Other animal parts that are common in these products are spleen, brain, pancreas, pituitary glands, pineal glands, heart, etc. the list goes on but I think you get the point.
Without a doubt people take medications and pills to combat sickness. How would you like to take a supplement if it was found to stop your medication from doing the job that it was supposed to do? The herbal supplement St. John s Wort inhibits necessary HIV/AIDS medications from working properly. This same drug also creates side effects with anti depressants and prescription drugs and it decrease the overall effectiveness of birth control pills. A worst case scenario of the pills is that some are not healthy for women to take when they are pregnant.
Regarding the claiming issue pertaining to dietary supplements, this side argued that the FDA should be legally responsible for the claims that companies make about the products. Again, the DSHEA law enacted in 1994 really gives drug manufacturers a great deal of leeway in the claims that they make about the products. Dietary supplements are different than other drugs in that they do not have to be proven safe or even effective. Unfortunately this puts a great deal of importance on ethics, and some companies have no problem lying about drug attributes if they can make more money because of the faulty claims.
Although drug products that can legally state certain drugs have the power to treat, prevent and heal specific diseases, dietary supplements cannot make that claim. Any supplement in the dietary category that makes such a claim would be unapproved, and therefore illegal. These laws are subsequently the only laws that have any affect on the dietary supplement market. The DSHEA act allowed claims if
A statement claims a benefit related to a classical nutrient deficiency disease and discloses the prevalence of such disease in the United States, describes the role of a nutrient or dietary ingredient intended to affect the structure or function in humans, characterizes the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function, or describes general well being from consumption of a nutrient or dietary ingredient.
The manufacturer of the drugs are usually responsible for explaining how a product works and what ingredients allow for the process to work. All dietary supplements must have a disclaimer on the bottle that reads This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.
The dietary supplement market is a huge business in the U.S. accounting for 3.2 billion dollars. One must seriously consider why people will shell out large sums of money on a product that in fact may not be healthy. One reason may be due to the fact that our country everything is portrayed as being safe, and checked for health hazards, especially those described as drugs. Perhaps this country takes that information for granted, and will just take anything regardless of what they know about a product. It is an American right to buy what they want and supplements are no exception. This may be another reason accounting for people spending money on the drugs.
Cost of FDA intervention and regulation is another reason for the lack of FDA presence in this particular market. To bring a new synthetic drug into the market has a 350 million-dollar price tag. These drugs are not allowed to be patented and therefore they would never get the money back from the FDA.
The last aspect of the pro side of the debate has to do with government regulation of advertising in regards to the supplement industry. As of now there are no restrictions on what a company can advertise about their products. Many people see something on television and feel that what is seen is 100% true, which we all know is not the case. The advertising for these products cannot be misleading in any way. The example used in the debate was that products that simply advertise LOSE 5 POUNDS IN 10 DAYS. This could be seen as misleading due to the fact that it never mentions that other steps must be taken to make the product work, at least in big print.
CONS of Regulation
I am now going summarize some of the high points that the con side brought to the forefront. Following the same format the cons of labeling will be first, then claiming will be discussed and advertising will be at the end.
People who purchase and use products of this nature can read and are responsible for their actions. The industry does label the products via a label that states that FDA supervision is less strict regarding supplements than it is when drugs are in question. This side of the debate clearly states that certain information is needed on the label, but all the health information is needed. The needed facts on the label include a descriptive name stating that the product is indeed a supplement, the businesses location, list of ingredients and the net contents of the product. This should be enough information for the consumer to decide if the product is in ones best interest or not.
Testing methods between manufacturers and researchers is in some cases extremely different presenting a new problem for the FDA. Some times when the manufacturer tests the products no side effects are detected. Then, in the next step of development a consumer based research group may do more extensive research and find a flaw in the product. Results of this nature are very highly debated and very shady. Should the manufacturer be found guilty of false labeling even though they felt that they were correct in their testing methods? This team believed that the manufacturers should not be accountable for the action.
The debate for non-regulation of claiming in the business has numerous good points that were well stressed upon by the team. It was argued that no false claims are made, and if one slips through the cracks it was accidental and fixed almost immediately.
A very great point that was brought up during the debate by the con team was that the claims made for dietary supplements meet the definition of a health claim as defined by the NLEA. The current FDA policy calls for the same type of scientific evidence and support and the same process for approval of NLEA claims on the dietary supplements as are required for conventional foods.
We have all seen the phrases rich in, high in, on many of the products that we purchase on a daily basis. Labels like these are very common when dealing with the supplement market. How can one argue about any claiming or labeling when these two phrases are obvious examples of both?
The supplements market has one major target audience; people looking to lead a healthy lifestyle. For this reason the claims put on the bottles can help people choose the stuff that can help them the most. The product should always be safe to the consumer when it used in the developed manner.
A great aspect of the lacking FDA regulation is that it allows for more products to be developed and promoted in the industry. Companies do not have to fear government intervention and therefore will be more willing to develop a product for the dietary supplement market.
Currently products in this category carry revised labels that inform consumers on what the fat, cholesterol, and dietary content is of each product. This strategy was implemented to help consumers choose healthier and nutritious diets. Labels of this sort place the responsibility on the consumer and hope that he/she will take the time to research the claims on their own time. All products of this nature offer consumers a toll free number to call and ask questions or address any concerns they may have. I feel that this shows the companies are going out of their way to help their customers and therefore further regulation is not needed by any government agency.
With the explosion of drugs and supplements hitting the market it would be nearly impossible to police the advertising that is used on all the products. The FDA has to spend time on the products that are used to help heal people and do not have the time or capital to focus on the supplement market. Since this is such huge money making industry the FDA does not want to single out any one company and make let others slide by.
The FDA is acting in a reckless way to make sure that they are not alienating the industry, says Sidney Wolf.
By this he is simply saying that the FDA is being lax on the industry to keep all parties happy.
Since product quantity has increased the advertising inevitably has followed the same route. In fact the FDA has made numerous prior mistakes regarding what they have and have not allowed. The easiest thing for them to do is to sit back and just skim over the market and do not focus too much on it. Independent groups claim that the FDA should not be able to regulate the drugs.
The current government stance regarding herbal supplements is that, they too do not have any regulations. These products must meet the same scientific criteria as conventional food. Although not regulated the products do carry a disclaimer stating that the drug is not FDA approved. I feel that this is warning enough for the consumer. The consumer cannot come back and complain about the product and its attributes when they knew full well the government did not back the product. The government may have found a cure to constant question of FDA presence or lack thereof. Congress concluded that perhaps pharmacists could work more closely with doctors who are prescribing the drugs in question. This would hopefully work and allow the FDA to focus on the more important tasks at hand.
Taking a drug off the market shelves can be an expensive and time-consuming task. This is why the FDA has been reluctant to stick their nose in to the supplement industries business. They simply place more warning labels on the product. This may sound beneficial but not many consumers take the time to read all of the print found on the label. During the 1980 s approving a drug to roughly three years, which is why the issue was not as huge as it is now. Since less drugs were out their, less drugs were likely to have negative side effects on people. Also the small amount of drugs on the market meant that there was less advertising to worry about. Currently drugs it takes about one year to get a drug developed and marketed. This is the major cause of the excess amount of advertising.
Prior to the debate I felt that perhaps the FDA should step in and place a few more restrictions on drug and herbal supplements. However, after watching the debate I changed my opinion and decided that there already are enough rules that companies must adhere to. Therefore, I feel that the team that argued that government regulation by the FDA is not warranted on drug and herbal supplements. Although, I feel that both sides presented their cases very strongly. It just seemed that the con side had more solid facts to back their opinions up.
I know that judges are supposed to be neutral, but personally I am against any more government regulations on our products. The government intervenes in nearly everything the American people do. The con side stated repeatedly that although there is no regulation, the FDA does watch over the industry and looks for any wrongdoing. That is what stance the government should take on more issues regarding the public and their personal decisions. The FDA does watch us, but they are not needed to baby-sit the American citizens.
Overall consumers are generally intelligent people and can think for themselves. When I look to buy a product I take full responsibility for my actions. If I have a question about a product, I will read what is given and if that does not answer my question I would call the number on the label. More people should take this approach and be more accountable for their actions. The United States society is already swamped with rules and regulations on everything, drug and herbal supplements should not fall in the category. The pro side stated that misleading ads such as Lose 5 pounds in 10 days should be illegal because we all know that it cannot happen that easily. The company making the product is aware of that and that is why the label reads that exercise and a good diet is needed to make the pills work.
In summary further government interference in this industry is not needed or wanted by the people purchasing the products. Let the public shop for what they want and be responsible for whatever that may be. Government agencies have more important things to do with their time and money than simply watch over supplements and wait for something to happen. Everyone knows that products extremely unhealthy are very rare, and that people do not have to worry about the drugs.