G. Douglas Andersen, DC, DACBSP, CCN
Today we will briefly discuss the two House of Representatives bills aimed at regulation of the nutritional supplement industry. Like Senator Hatch's bill (S 784), these bills also help define the FDA's role in regulating supplements.
Last month we reviewed some Poison Control Center statistics about vitamins, which showed one death from vitamin overdose between the years 1983 and 1990. This month I would like to present a few statistics about prescription medication for the geriatric population.
- In 1990, 659,000 Americans over 60 were hospitalized with problems that were caused by medication.1
- 3,300 senior citizens die each year from ulcers caused by nonsteroidal anti-inflammatory drugs, most of which are used for arthritis.2
- 16,000 automobile accidents that result in injury are due to senior citizens driving under the influence of medicine they were prescribed.3
- 1,500 senior citizens die each year from complications of hip fractures which were caused by drug-induced falls.4
- 61,000 senior citizens have medication-induced parkinsonism.1
In July of 1993, FDA Commissioner David Kessler testified before a congressional subcommittee and gave them a report that included a list of supplements the FDA considered hazardous. These included guar gum, ma huang, glandular extracts, and ephedra. Although I admit my literature search was not exhaustive, I was unable to find any deaths caused by these substances.
We will now briefly review the House of Representatives bill HR 1709 from Bill Richardson (D-NM). It is similar to Senator Hatch's S 784 except: (1) it mandates an RDA update, but does not require that the new values be based on optimal levels, as opposed to adequate levels; (2) does not require a history of safe use of a substance when the FDA decides if a substance is dangerous or not; (3) requires the manufacturer notify the FDA 30 days before a supplement label or an insert makes a new health claim.5 In contrast, S 784 allows manufacturers to make claims if there is support in the scientific literature without notifying the FDA in advance.
HR 2923 is from Cardis Collins (D-Ill). This is the bill that supports the FDA rule and that the FDA is supporting. If this bill passes, amino acids and herbs would likely be pulled from the market. In the literature Representative Collins sent me, she states: "Most importantly, this bill addresses my continuing concerns about the health of older Americans."6
Summary
We need legislation passed to protect the consumers, and that legislation is S 784. If this is not passed, HR 1709 is an alternative that we would be able to live with, with some added difficulties. In contrast, HR 2923 would decimate the nutrition supplement industry and, in this author's opinion, have a marked effect on the health of our nation. I think we are all concerned with the health of older Americans. Clearly, the FDA has plenty to do regulating substances that cause thousands of deaths per year. We need an FDA that will start working for the people (banning toxic drugs) instead of against the people (harassing honest companies or banning beneficial substances).
To preserve our right to utilize nutritional supplements, I strongly urge you contact your senators and representatives with your opinion on these bills.
References
- Wolf S, Hope R: Worst Pills, Best Pills II. Public Assistance Health Research Group, 2000 P. St. NW, Suite 700, Washington, D.C., 20036. 1993.
- Ray WA, Griffin MR, Shorr RI: Adverse drug reactions in the elderly. Health Affairs. Fall 1990; 114-122.
- Ray WA, Fought RL, Decker MD: Psychoactive drugs and their risk of injurious motor vehicle crashes in elderly drivers. American Journal of Epidemiology, 1992. Vol 136, 873-883.
- Ray WA, Griffin MR, et al.: Psychoactive drug use and the risk of hip fracture. New England Journal of Medicine, 1987. Vol 316, 363) 369.
- Personal Facts of HR 1709, "Dietary Supplement Health and Education Act of 1993 Section Analysis." Bill Richardson, (D-NM).
- Congressional Letter on the Dietary Supplement and Consumer Protection Act of 1993 (August 1993), and the news release (August 6, 1993) from Congressman Cardis Collins, (D-Ill).
G. Douglas Andersen, DC
Brea, California
