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Supplement Regulations
...there aren't many.
Before one decides to use an herbal
supplement, one needs an understanding of how dietary and herbal supplements are regulated
in the United States. In quite simple terms, supplements are
largely unregulated. This means that the supplement you take has no real standard
in chemical composition, production, or recommended usage.
The FDA (Food and Drug Administration), the federal department in charge of
overseeing the drug and food industries in the United States, is also relatively in
charge of the dietary and herbal supplement industry. However, the extent of their control
extends only to labeling, and the actual content and use of supplements
is unregulated. The DSHEA (Dietary Supplement Health and Education Act)
passed by Congress in 1994 outlines the FDA's breadth of oversight on the
supplement industry. The DSHEA allowed broadening of the definition of
supplements to include herbal medicines. It also dictated that while the
FDA could mandate what needed to be included on the labels of supplements, the FDA could
not require that dietary and herbal supplements adhere to the same strict
criteria of demonstrating safety and efficacy as do conventional prescription
medicines. Further, there is no requirement that dietary supplements must
have a specific or standard composition from company to company, meaning that
the amount of "active ingredients" may be either significant or miniscule. Thus,
one Echinacea supplement may be, and most likely is, vastly different from
another Echinacea supplement.
As stated, the FDA does have guidelines for labeling.
This includes the prohibition of claiming to cure or treat any disease or
ailment, or the implication that use of a supplement is a cure. Labels may
claim to promote health. In January of 2000, the FDA broadened
its label oversight, and also prohibited the tradename of a supplement from implying a
cure. Labels must provide information regarding the amount (weight)
of different components contained in the supplement, the recommended serving
size or usage instructions, and a mention of all botanical and herbal
ingredients.
The DSHEA also provided the authority for the
FDA to put into motion the processes needed to try and gain stricter control on
the dietary and herbal supplement industry. This includes the establishment
of standard production practices, and impetus to require scientific evaluation
of supplements. The DSHEA also provided for the establishment of a
council to oversee CAM, including herbal medicine.
The dietary and herbal supplement industry
is an unregulated industry. Efficacy and safety profiles are largely
unstudied. Recognize that the supplement you take may have various
additives, may be adulterated, or may harm you and your baby. |
