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How Safe Are Your Dietary Supplements?

The use of dietary supplements has become part of our everyday lives. Dietary supplements are on every shelf in every pharmacy across the nation and consumers are purchasing everything from Vitamin C to fish oils to the tune of billions of dollars per year. But how are all these product regulated? Who is making sure that what is claimed on the label is fact and who is making sure these products are safe? The answer may surprise you.

The Food and Drug Administration (FDA) leaves it to the manufacture of the supplements to make sure that what they are producing lives up to the health quietum plus claims they are purporting. In other words, if a supplement is claiming that it provides you with the daily recommended allowance of any specific vitamin it is the responsibility of that manufacturer to hold true to that claim and to make sure it is safe. The following are direct quotes from the FDA concerning the regulation or lack thereof regarding dietary supplements:

“FDA regulates dietary supplements under a different set of regulations than those covering “conventional” foods and drug products (prescription and Over-the-Counter). Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed. FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market. Generally, manufacturers do not need to register their products with FDA nor get FDA approval before producing or selling dietary supplements. Manufacturers must make sure that product label information is truthful and not misleading.”

Note that the FDA will not take action against any supplement until after it is put to market, meaning that it will take a consumer complaint before the FDA will investigate the validity of any health claim that a product is making as further clarified in the following quote:

“FDA’s post-marketing responsibilities include monitoring safety, e.g. voluntary dietary supplement adverse event reporting, and product information, such as labeling, claims, package inserts, and accompanying literature. The Federal Trade Commission regulates dietary supplement advertising.”

The FDA delegates the advertising of any specific supplement to the Federal Trade Commission (FTC). The FTC requires sufficient back up to the claims that these supplements are making and that the supplements will perform as advertised. The FDA additionally requires that any existing supplement which has been reformulated with a new ingredient be submitted for review to validate its safety to the consumer.

Proponents of dietary supplements believe that when properly applied supplement to a diet and exercise program can be of great benefit to the consumer.  But it is the consumer’s responsibility to do the research to make sure that any supplement is right for them. Despite the FDA and FTC efforts to make sure that the product is safe, the chief concern is not what these manufacturers are reporting, but the concern is over what they are not reporting. For example, if you are looking to purchase a fish oil supplement make sure that the source of the fish oils is outlined on the label. There are several brands which do not list the source or the type of fish the oils have been extracted from. Also there are several “watch dog” groups out there who have taken it upon themselves to do the follow up research on a product to insure that what that product is claiming is in fact true. However even that information is not readily accessible,

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