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FDA
INFORMATION
Since the passage of the Food, Drug, and
Cosmetic Act, Congress passed Dietary Supplement Health and Education
Act (DSHEA) in 1994. DSHEA created a new food category for dietary
supplements. In order for the FDA to remove a dietary supplement
from the market, it must prove that the product causes undue harm to
consumers. The FDA does not control low dose hormones or
homeopathics, except when false or misleading claims are made, or purity
or ingredient violation arise.
DSHA allows for low dose hormones (e.g. oral
HGH, DHEA, melatonin, phytoestrogen, wild yam cream, natural
testosterone, etc.) to be sold and marketed as dietary supplements.
When delivered using a safe method of administration (e.g. oral spray,
tablet, capsule, cream, etc.) hormones fall into the category of foods,
not drugs.
Therefore under the DSHEA of 1994, low
dosage, orally administered IGF-1 is marketable without a prescription.
AWAKEN IGF-1 is manufactured by a FDA
approved facility.
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