Misbranding, Adulteration and Dietary Supplements

After the announcement last week that DHEA was ineffective at reducing aging, there were lots of discussion, as mentioned in Friday’s Food Fables, about the success/failure of dietary supplements. At the end of her post Tara, of Aetiology, asked what should now happen to the National Center for Contemporary and Alternative Medicine (NCCAM), but that might be the wrong question.

Dietary supplements, and I restrict my discussion to them, are regulated by the FDA under the Dietary Supplement, Health and Education Act (DSHEA) which was passed by Congress in 1994.

The following definitions are important to understand what we can or cannot regulate. According to DSHEA:

A dietary supplement:

  • is a product (other than tobacco) that is intended to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for use by man to supplement the diet by increasing the total daily intake, or a concentrate, metabolite, constituent, extract, or combinations of these ingredients.
  • is intended for ingestion in pill, capsule, tablet, or liquid form.
  • is not represented for use as a conventional food or as the sole item of a meal or diet.
  • is labeled as a “dietary supplement.”
  • includes products such as an approved new drug, certified antibiotic, or licensed biologic that was marketed as a dietary supplement or food before approval, certification, or license (unless the Secretary of Health and Human Services waives this provision).

To discuss dietary supplement efficacy and safety, we need to know that DSHEA defines adulteration for dietary supplements as:

The DSHEA amends the adulteration provisions of the FD&C Act. Under DSHEA a dietary supplement is adulterated if it or one of its ingredients presents “a significant or unreasonable risk of illness or injury” when used as directed on the label, or under normal conditions of use (if there are no directions).

The provisions of the Food, Drug and Cosmetic Act (FD&C) that were amended for dietary supplements are defined in the Code of Federal Regulations (CFR) 21; Sec. 101.18. See also here: adulterated food and misbranded food.

Food cannot be sold under a different name, including geographical location and that all ingredients present must be listed. The FDA regularly tests food from production to point of sale, and there had better be the amount of nutrient in the food that is stated on the label and no ingredients present that are not listed in the ingredients list. Thus, where food is concerned, the misbranding and adulteration of food is not only banned but illegal. People have been fined and sent to jail for falsely selling food.

A dietary supplement is only considered adulterated if it presents “a significant or unreasonable risk of illness or injury”. There is no proviso about the:

(b) Absence, substitution, or addition of constituents

as there is for food. This has given rise to concern over the contents of dietary supplements. The nonprofit organisation, Consumer Labs, does tests on dietary supplements and herbs. Unfortunately, there are too often problems; for example, tests on valerian show that ten out of sixteen brands failed Consumer Labs analytical tests for either having too low potency or for containing contaminants.

Related to this is the identity of the active compound, which for many of dietary supplements is unknown. So how do we test to see if it present? This is without even starting to worry about the efficacy of dietary supplements. In fact, while DSHEA restricts what can be claimed on a dietary supplement to structure-function claims. Other claims have to come with the proviso:

“This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease”

One of the suggestions in the comments of the article over at Aetiology, is that we just wait for some one to die. But people have, both with Ma Huang -the herbal version of ephedra and with a contaminated source of tryptophan:

The Centers for Disease Control and Prevention (CDC) has identified more than 1,500 cases of EMS, including at least 38 deaths associated with the use of L-tryptophan.

In fact, the FDA has a dietary supplement list of warnings. All that happens, and all that can happen, is that a particular dietary supplement is banned. Even senators such as Orrin Hatch (R-UT) support bills to tighten up on the reporting of adverse events:

The bill [June 2006] would require that reports be filed to the Food and Drug Administration within 15 days about what it calls “serious adverse events.” It defines those as death, hospitalization, or what it calls a significant disability or incapacity, among other things.

Before this less than one percent of adverse reactions were reported to the FDA. Whether DSHEA ever be changed to have even tight restrictions, especially to include efficacy, seems unlikely as Senator Hatch was responsible for drafting the originally DSHEA so that it:

… specifically exempted makers of diet supplements from having to prove to the FDA that they are safe and effective.

As dietary supplements are not foods or drugs, they are regulated differently to both. Manufacturers of dietary supplements do not have to register with the FDA or prove that they are effective. Dietary supplements are not routinely tested for adulteration or misbranding, and the definition of adulteration/misbranding is different for dietary supplements compared to food. Frequently, it seems, dietary supplements do not pass analytical tests for apparent active components or contain a high level of contaminants. There have been a number of serious adverse reactions to dietary supplements and yet DSHEA is not being changed, except, may be, to improve the reporting of adverse reactions.

What does NCCAM have to do with any of this?

Nothing, it seems, much. DSHEA may have bought it into exsistence, but there does not seem to be a link between the FDA and NCCAM.

Will closing down NCCAM have any affect on the dietary supplement industry?

No because they are mostly concerned with marketing NOT with efficacy. The only way that dietary supplements can be better controlled is by improving DSHEA.


3 thoughts on “Misbranding, Adulteration and Dietary Supplements

  1. Pingback: easternblot.net » Tangled Bank - The Future, Present, and Past

  2. adultration is common practcised by the manufacturers and in marketed,for this regulations by the goverment but not proper of regulation and adultration present in marketed mineral supplement use for animals

  3. Just like vitamins and minerals, herbal supplements are subject to loose regulation and labeling standards. In fact, the purity of these supplements is questionable and many are associated with dangerous side effects.

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