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How Supplements Are Regulated by FDA

Taking any kind of supplement, eating any kind of food, drinking any kind of beverage or using any kind of personal care products all come with a certain level of risk. Most of us never think of there being a risk with something that is sold in our friendly neighborhood grocery store, pharmacy or on the internet. The pictures on the bottles and bags depict healthy folks enjoying the benefit of whatever the product is supposed to do.

As I have posted on before, we often buy products based on the picture on the label rather than reading the ingredients list on the back! It is wise to read and do your own research into a company’s claims. I have seen many in my time that promise all sort of benefits that Dr X is touting, but there are rarely any published, peer-reviewed scientific studies supporting Dr X’s claims. Testimonies are not clinical studies. And having a clinical study published in a peer-reviewed journal is having the study vetted by a large group of scientists from all over the world. Peer-reviewed studies that are published take time and have to be done to high standards of testing.

The FDA does regulate supplements. But not in the same manner as prescription and over-the-counter medications. This from the FDA website:  ” 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.

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.

*Domestic and foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States are required to register their facility with the FDA.”

DSHEA places dietary supplements in a special category under the general umbrella of “foods,” not drugs, and requires that every supplement be labeled a dietary supplement.  FDA regulations require that certain information appear on dietary supplement labels. This includes: a descriptive name of the product stating that it is a “supplement;” the name and place of business of the manufacturer, packer, or distributor; a complete list of ingredients; and the net contents of the product.

In addition, each dietary supplement (except for some small volume products or those produced by eligible small businesses) must have nutrition labeling in the form of a “Supplement Facts” panel. This label must identify each dietary ingredient contained in the product.
Ingredients not listed on the “Supplement Facts” panel must be listed in the “other ingredient” statement beneath the panel. The types of ingredients listed there could include the source of dietary ingredients, if not identified in the “Supplement Facts” panel (e.g., rose hips as the source of vitamin C), other food ingredients (e.g., water and sugar), and technical additives or processing aids (e.g., gelatin, starch, colors, stabilizers, preservatives, and flavors).

So take a good look at your supplement labels, read them well.  Do some research and see if the claims are backed by real science or are they just from testimonies only.  Do yourself a favor and make wise choices when you supplement.  That is why I like my Shaklee supplements, the science is there for each product, the purity is there and the potency is always there. Stay Well!

 

2 Comments

  1. Adriana says:

    thanks for share!

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  2. Adriana says:

    thanks for share!

    [WORDPRESS HASHCASH] The poster sent us ’0 which is not a hashcash value.

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