Regulatory Provisions for Supplements

Regulatory Provisions for Supplements

Dietary supplements may one day lose their ability to be purchased without a prescription if the Adverse Event Reporting (AER) measure that is currently before Congress is passed. In this day and age of frivolous and hasty lawsuits, Congress is poised to enact legislation that would allow private individuals to sue the supplement makers, and maybe the markets as well, for health-related disorders that are purportedly caused or exacerbated by dietary supplements. 

This proposal would allow private citizens to sue supplement manufacturers in this day and age of offhand and frivolous lawsuits. This package would also include the reporting of "adverse events" by the industry in a very formal manner, which would be significantly more complicated and thorough than the standards that are currently in place. In a court of law, both the manufacturer and the distributor of these supplements can be held accountable for the appropriate or inappropriate usage of the products. This is the legal equivalent of suing the butcher because I choked on a piece of steak or even suing my barber because I'm not featured on the cover of GQ magazine. Neither of these scenarios is remotely plausible. Ridiculous!

Due to the nature of the proposed legislation, it is possible that it is accurate to say that the parties responsible for bringing this matter to the attention of the public and legislators are uneducated, misinformed, and misguided. They are blind to the bigger picture, which is that the nutritional supplement sector could be wiped out if this measure is passed, and the bigger picture is that they are blind to the bigger picture. 

Along with the arrogant "bull in a china shop" mentality that Congress has toward "protecting" the private sector, they are on track to eliminate our freedom of choice in areas pertaining to health-related issues. There is also the very real risk that the legislators will approve the currently proposed AER measure. This is due to the fact that certain entities (such as Senator Dick Durbin) have vowed to re-introduce the issue in the event that it is defeated, and this time they will include more detrimental regulations that will have an impact on the industry. This has nothing to do with keeping us safe. In reality, the goal is to win votes from members of the public who are misinformed about the issue by politicizing a risk that does not exist.

The AER bill that is currently being debated in Congress is not a new topic. In August of 2004, a bill that was quite comparable to this one was shot down in the California Assembly. At the time in question, many of the reasons indicated before were, as may be expected, the subject of controversy. It was extremely prudent that the bill's true nature be recognized, as a result of which it was soundly rejected. According to recent thinking in Washington, state-by-state regulation of nutritional supplements is practically nonexistent, and when given the opportunity, such as in California in 2004, "small-time" lawmakers from these States will completely botch the chance to adequately "protect" the average clueless consumer from this "real danger." The reasoning behind this line of thinking is based on the observation that many consumers are unaware of the "real danger" that nutritional supplements pose.

Washington continues to push on with its agenda in spite of opposition from Robert Brackett, who is the head of the Center for Food Safety and Nutrition (CFSAN) at the Food and Drug Administration. Mr. Brackett made it clear that there is already sufficient regulatory authority in place thanks to the Dietary Supplement Health and Education Act (DSHEA), and he referred to this authority in the phrase "existing and existing." In addition, while appearing in front of Congress, he emphasized that the present administration had no plans to alter the policy that was already in place. When it comes to matters of supplementation, he is an advocate for the individual's right to make self-directed, well-informed decisions about their own health.

Kathleen Jordan, the general manager of NSF International, testified before Congressional lawmakers during the same hearing that the development of the Dietary Supplement Certification Program speaks volumes for informing consumers and allowing them adequate protection from the unregulated sale of supplements. The charitable and non-governmental organization is at the forefront of developing rational and equitable concepts, such as the recently formulated NSF/ANSI Standard 173, which ensures accurate nutrient counts and the identification of ingredients. Regarding one particular issue, it looks like everyone is on the same page. 

That is, stricter regulations regarding the presence of anabolic steroids, which were once found in items labeled as "sports supplements," People are confused about the difference between harmful chemicals like steroids and safe nutrient supplements like vitamins, minerals, and herbs because of the improper usage of the term "supplement" in this context. One of the causes of this confusion is that the phrase "supplement" has been misused.

The majority of people who take vitamins and supplements do so according to a schedule that they have self-imposed, which is often determined by the recommended daily allowance (RDA). Every day, I make sure to take the appropriate number of vitamins, minerals, and other supplements by consulting both the Recommended Dietary Allowance (RDA) and the advice of my personal physician. To put it another way, I always have vitamins in my body because I always make sure to stick to the plan that I set for myself. 

If I thought that taking the recommended daily allowances (RDAs) of vitamins, minerals, and herbs might have any kind of negative impact on my health, I would immediately stop doing so. Simply due to the fact that it is being debated in Congress, a significant number of individuals are going to have the misconception that a genuine risk is present. Others, who will inevitably experience some form or another of deteriorating health, will also remember that a controversy regarding dietary supplements carried on for years.

Even if the supplements have absolutely nothing to do with the patients' illnesses, they will file spurious lawsuits against supplement manufacturers if the legislation passes and allows such litigation to proceed. Sadly, one cannot foresee how things will turn out in the end. 

The supplement business will be compelled to regulate in order to protect their bottom line, and you won't be able to purchase dietary supplements without a prescription from a medical professional. In addition, the responsibility for every disease ever known to man will be placed on innocent vitamins. Remember that you had this one opportunity to voice your opinion by writing, calling, or emailing your Senator or Congressman. When you then drive to your local drug shop and are forced to pay hundreds of dollars for what are essentially dietary supplements, think back to when you had this chance.

Send a fax to Senator Dick Durbin at this number: 202-228-0400. Also fax Senators Tom Harkin and Orrin Hatch at these numbers: 202-224-9369 and 202-224-6331. Send a fax to the number 202-228-0359, addressed to Senator Michael Enzi, who serves as the Chairman of the Senate Subcommittee on Health, Education, Labor, and Pensions. Tell them that you deserve the right to choose your own nutritional supplements and other matters pertaining to your health on your own accord. The reality of the situation is that the AER bill is flawed! It is not right for the average citizen, and it is not right for the company that makes dietary supplements. It is not good for the United States!