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To: bmart who wrote (586)	8/22/1998 11:44:00 AM
From: Arcane Lore	Respond to of 26163

... There are many links available regarding nutritional supplements and FDA approval.....they are not required of nutritional supplements. BMart: Simply because dietary supplements do not require FDA approval does not mean they have license to promote themselves by making unwarranted health claims about specific diseases. The following excerpt from an FDA web site concerning the Dietary Supplement Health and Education Act of 1994 (DSHEA) may be of interest: NUTRITIONAL SUPPORT STATEMENTS The DSHEA provides for the use of various types of statements on the label of dietary supplements, although claims may not be made about the use of a dietary supplement to diagnose, prevent, mitigate, treat, or cure a specific disease (unless approved under the new drug provisions of the FD&C Act). For example, a product may not carry the claim "cures cancer" or "treats arthritis." Appropriate health claims authorized by FDA--such as the claim linking folic acid and reduce risk of neural tube birth defects and the claim that calcium may reduce the risk of osteoporosis--may be made in supplement labeling if the product qualifies to bear the claim. Under DSHEA, firms can make statements about classical nutrient deficiency diseases--as long as these statements disclose the prevalence of the disease in the United States. In addition, manufacturers may describe the supplement's effects on "structure or function" of the body or the "well-being" achieved by consuming the dietary ingredient. To use these claims, manufacturers must have substantiation that the statements are truthful and not misleading and the product label must bear the statement "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease." Unlike health claims, nutritional support statements need not be approved by FDA before manufacturers market products bearing the statements, however, the agency must be notified no later than 30 days after a product that bears the claim is first marketed. vm.cfsan.fda.gov

To: bmart who wrote (586)	8/22/1998 12:13:00 PM
From: Janice Shell	Read Replies (3) \| Respond to of 26163

PUAMA It's "100% pure and natural ingredients" work to fight many problems of the respiratory system. ...it goes on to say "Hydrastis" heals cicatrizant membranes by helping to remove scar tissue.... OOOHHHH. That's what it says at the website, so it must be true, right? Here's a rather more scientific evaluation of hydrastis: Goldenseal (Hydrastis canadensis) Purported Use: Antimicrobial for urinary tract infections, astringent, antihemorrhagic, adulterant of illicit drugs (morphine, cocaine, and marijuana) in urinalysis tests, eye washes, rheumatic or muscular pain, antispasmodic, and treatment of menstrual disorders. German Commission E Indications: Information unavailable. Efficacy: Clinical experience suggests goldenseal may "cleanse" the liver or blood and restore digestive function in alcoholics. Unproven as an agent for urinary tract infections and hemorrhage. Wu et al. evaluated the effect of adulterants on urine screening for drugs of abuse by using the cloned enzyme donor immunoassay (CEDIA) technique. Goldenseal tea altered urine assays containing amphetamines and tetrahydrocannabinol but not assays containing barbiturates, benzodiazepines, cocaine, opiates, or phencylidine. Mechanism of Action: Unknown. Goldenseal contains berberine that has antibacterial and amoebicidal properties. Contraindications/Precautions: Avoid in pregnancy-uterine stimulant. Not recommended for internal use because safety and efficacy are lacking. Drug Interactions: None reported. Side Effects: Large doses may irritate the mouth and throat and cause nausea, vomiting, diarrhea, hypoglycemia, and paresthesias. In higher doses, one of the alkaloids (hydrastine) may cause exaggerated reflexes, hypertension, and convulsions. CNS stimulation and respiratory failure may be fatal. Dosage (mouthwash): 2 teaspoons (6 grams) of herb and 1 cup of water TID-QID. References: Wu AH et al. CEDIA for screening drugs of abuse in urine and the effect of adulterants. J Forensic Sciences 1995;40(4):614-8 uiowa.edu