For all the talk lately about the lack of trust in government, people take it for granted that any product for sale in the U.S. is automatically safe to use – including supplements found in health stores, drug stores, and grocery stores. After all, if they weren’t safe you’d either need a prescription or you couldn’t find them. Right?
FDA’s Supplement Oversight Power
Believe it or not, the Dietary Supplement Health and Education Act of 1994 states that the U.S. Food and Drug Administration (FDA) has no power to “pre-approve” dietary supplements. They law does give them the power to remove or ban the sale of any product that is suspected of containing illegal ingredients, such as animal parts. The problem is that this aftermarket action is very complicated to enforce.
- It is up to consumers and health care providers to notify the FDA that there is a potential problem with a given product.
- Manufacturers are required to submit a notice of new ingredients to the FDA but the definition of what constitutes “new” is vague and there is no way to ensure that a manufacturer is compliant with the law.
- Dietary supplement firms are known to change the name of the product without the knowledge of the FDA after the supplement is banned by name.
- There are too few agents to follow up on the more than 55,000 dietary supplements sold in stores across the U.S. and fewer still to monitor imported products sold online.
The FDA’s Office of Dietary Supplement Programs has recently put forth a revised guidance for the Notification of New Ingredients” that would empower the government to have the ability for the first time to identify unsafe ingredients before they hit the open market. While this still wouldn’t prevent fraudulent supplements to be sold on the Internet, it would be a step forward in the protection of U.S. consumers.
The Importance of Supplement Safety
One of the most dangerous health issues related to dietary supplements is that ingredients are sometimes absent from the labeling, sometimes illegal in the U.S., and other times the name of an ingredient is changed when it has been outlawed.
Ingredients that are hidden or not reported on the labels include items that are laced with molds and known poisons. Illegal ingredients are often not listed. For instance, one product known as Zi Xiu Tang Bee Pollen has been flagged as it contains undeclared sibutramine and/or phenolphthalein. Other illegal ingredients include animal parts such as oxen and bull penis, and bovine eyes since these typically are contaminated with molds, mildews, and/or fecal matter.
An example of the latter is the ingredient called Oxilofrine. In 2004, this ingredient was outlawed as extremely dangerous and having caused thousands of deaths in the U.S. At that time, it was called ephedra. Manufacturers gave it a change in name and a subtle tweaking of the chemical composition. If Oxilofrine had been reported under the “new ingredient” regulation, it would have been caught before more people suffered death and permanent injury.
Oxilofrine is also marketed under the name Methylsynephrine, which many consumers believe is the same as Synephrine, which is a natural component of bitter oranges. Unfortunately, there are many names on labels that are designed to deliberately mislead buyers.
Consumer Reports lists Lobelia and Green Tea Extract Powder among the top 15 ingredients to always avoid. Both are known to potentially cause death while the other side effects are equally undesirable – some causing permanent health issues.
The FDA and Consumer Reports as well as multiple medical research and health organizations are sending out alarms about supplements sold for the purpose of increasing energy, assisting in weight loss, increasing muscle mass, and normalizing erectile function. Additionally, they warn against taking anything marked or marketed as “100% Natural” as if an ingredient that is natural, such as Lobelia, is not deadly. The best protection available at this time is “Buyer Beware”.