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TOP 10 TAKEAWAY MESSAGES:
Supplements and OTC Therapies
1. Prescription drugs are a therapeutic medicine intended for the
diagnosis, cure, mitigation, treatment or prevention of disease.
Their approval and marketing is overseen by the U.S. Food and
Drug Administration.
2. OTC medications are drugs the FDA considers safe and effective,
but do not require a prescription by health professionals. Their
approval via the FDA involves an OTC drug monograph regulatory
process, and their marketing is overseen by the Federal Trade
Commission.
3. Supplements are substances taken in addition to dietary intake
(e.g., vitamins, herbs, botanicals, minerals and amino acids). The
FDA does not approve supplements, since they are considered a
food and not a drug.
4. Supplements are not permitted to be marketed for the purpose of
treating, diagnosing, preventing, or curing diseases.
5. Functional Foods are nutrients with potentially favorable effects
beyond basic nutrition (e.g., oatmeal may lower cholesterol).
6. Herbal and dietary supplements are a common cause of
hepatotoxicity (e.g., anabolic steroids and green tea extracts),
especially multi-ingredient nutritional supplements.
7. Most dietary supplements have limited to no consistent data to
support long-term weight loss efficacy and safety and have the
potential for adverse interactions when used as supplements to
drugs.
8. Some weight loss supplements continue to be marketed, even
when banned by the FDA due to adverse effects.
9. Patients should be advised of the limited evidence supporting
the efficacy and safety of many supplements and the lack of
oversight by government agencies regarding the claims made
about such supplements.
10. Human chorionic gonadotropin (HCG) is not effective for weight
loss beyond hypocaloric intake. The FDA requires clinicians and
facilities that market HCG for weight loss to post a disclaimer that
"There is no substantial evidence that HCG increases weight loss
beyond that resulting from caloric restriction, that it causes a
more attractive or normal distribution of fat, or that it decreases
the hunger and discomfort associated with calorie restrictive
diets."
