Let’s start this article with a riddle. What do more than 50% of Americans spend billions of dollars on yearly, and is the most popular alternative health therapy in the nation? If you answered dietary supplements instead of Disney World you are correct.
What goes on behind the shelves and shelves of products with 1000 new ones being introduced annually? As you stand there deciding you need to know who and what is involved in the behind the scenes action. Often obscured by cryptic acronyms this article will reveal their true identity and purpose.
The Dietary Supplement Health and Education Act (DHEA), was created in 1994 to oversee this industry. Although it contains regulations and gives authority to the FDA(see below) for enforcement, it is industry friendly legislation. For example it was more than 10 years after the Act was created before manufacturers had to inform the FDA of adverse effects its products caused in consumers. In contrast, it is mandatory that drug companies reveal that information.
The suppliers to the manufacturers are often located overseas, where regulations are different. Geography dictates a lack of inspection and oversight by the FDA.
The Food and Drug Administration(FDA) is a government body created to protect consumer health by ensuring the safety of food, drugs, biological products, and medical devices among others. It assists in advancing innovation on food and drugs to make them more effective, safer, and affordable. It is supposed to facilitate public access to accurate information on food and drugs that improve health. Chronically understaffed, it never asserts its authority to the fullest extent.
There is also the Government Accountability Office(GAO) who has sent senior citizens undercover to catch salesmen in lies about their products. Even though it is against the laws to claim that any supplement can prevent, cure, or treat almost all diseases, these claims are still being made.
Industry lobbyists do their best to get Congress to water down or delay any legislation they perceive as infringing on their right to make profits.
These are harsh words but let’s examine the facts behind them. The Natural Medicine Comprehensive Database lists 54,000 supplements, but only a third of them have scientifically proven safety and effectiveness. Over 10% have safety or quality concerns.
Yet in the dietary supplement market manufacturers are not required to prove their product is effective or that they have tested it for safety. This is in contrast to other countries like Canada where these products must undergo pretesting before they are available for purchase.
Aside from the fact that many products are being purchased are ineffective the more troubling problem is that there are some that harm consumers, and have not been removed for sale. Why? The manufacturers are waiting for the FDA to order them recalled. The FDA tends not to ban a product outright but instead issues warnings, and requests companies remove unsafe products from the market. Only once has it used its authority to order a ban; on ephedra weight loss products. The imposition of the ban took a decade during which time many consumers suffered adverse effects including death. In their actions the industry is passing the buck to the FDA whose watchdog capacity has little bark and even less bite.