Dietary Supplements Overview

Dietary Supplement Health and Education Act (OSHEA)

• Regulates dietary supplement safety, requiring labeling specifications.
• FDA lacks authority to pre-market approval of dietary supplements.

Dietary Supplements

• Clinical trials are not required.
• FDA can remove unsafe supplements from the market post-marketing.
• Dietary supplements are labeled as food.
• FDA provides recommendations, but does not regulate.
• Manufacturing verification marks ensure labeled contents are present (Quality Assurance Program).

Dietary Supplement Claim Statements

• Cannot claim prevention or cure of conditions.
• Example claims:
  • Diet low in sodium reduces blood pressure
  • Contains very low sodium
  • Calcium builds strong bones

Dietary Supplement Points to Cover

• Appropriate use
• Special groups (e.g., pregnant women, children)
• Adverse effects
• Interactions (with other supplements, medications etc.)
• Expectations

St. John's Wort

• Mechanism of Action (MOA): Activates GABA and glutamate receptors; potentially inhibits monoamine oxidase inhibitors.
• Uses: Depression, anxiety, OCD, menopause, premenstrual symptoms.
• Dosage: 900–1,800 mg daily in 3 divided doses.
• Safety/Monitoring:
  • Therapeutic effect may not be evident for weeks, especially with antidepressants.
  • Avoid in bipolar disorder and schizophrenia.
  • Limited evidence in pregnancy and lactation.
  • Potent CYP3A4 inducer.
  • Potential for serotonin syndrome.
• Side effects: Nausea, fatigue, skin reactions.

Alpha Lipoic Acid

• MOA: Cofactor for glucose metabolism; acts on glucose transporters to stimulate glucose uptake.
• Uses: Diabetic peripheral neuropathy.
• Dosage: 600 mg three times a day (TID).
• Safety/Monitoring:
  • May decrease food absorption.
  • Take on an empty stomach, separated from antacids and mineral supplements.
  • Avoid in individuals with thyroid conditions.
  • Monitor glucose concentration.
  • Helps prevent neuropathy progression.
• Side effects: Headaches, nausea, diarrhea, rash.

Saw Palmetto

• MOA: Inhibits 5-alpha reductase and cytoplasmic androgen receptor binding.
• Uses: Benign prostatic hyperplasia (BPH).
• Dosage: 160 mg twice daily (BID) or 320 mg daily.
• Safety/Monitoring:
  • Not effective in treating urinary symptoms.
  • Contraindicated in pregnancy.
  • Avoid concomitant use with antithrombotics (increased bleeding risk) and androgens.
  • Avoid during lactation.
• Side effects: Gastrointestinal complications, fatigue, headache.

Black Cohosh

• MOA: May modulate serotonin.
• Uses: Premenstrual syndrome, dysmenorrhea, menopause, rheumatoid arthritis (RA).
• Dosage: 40 mg daily in 1–2 divided doses.
• Safety/Monitoring:
  • Should not be used for more than 6 months.
  • Additive effect with Tamoxifen.
  • No effect on vaginal epithelium, endometrium, or hormone concentration.
  • Avoid in pregnancy and lactation.
• Side effects: Headaches, rash, gastrointestinal complaints, weight gain, hepatotoxicity.

Evening Primrose Oil

• MOA: Consists of omega-6 essential fatty acids; responsible for anti-inflammatory activity.

Melatonin

• MOA: Regulates sleep and circadian rhythm.
• Uses: Sleep, jet lag.
• Dosage:
  • Sleep: 0.3–5 mg (30–60 minutes prior to bedtime)
  • Jet lag: 2–5 mg in the evening upon arrival and at bedtime for the following days.
• Safety/Monitoring:
  • Use in adolescents is controversial due to potential hormonal effects on sexual development.
• Side effects: Nausea, vomiting, headache, irritability, dysthymia, worsening of depressive symptoms.

Fish Oil (Omega-3 Fatty Acids)

• MOA: Decreases cholesterol absorption, inhibits enzymes involved in cholesterol, excretion, and degradation of very-low-density lipoproteins
• Uses: Lowering triglycerides, improving heart health, treating depression, relieving inflammatory conditions (e.g., rheumatoid arthritis).
• Dosage: 1–2 grams daily.

Other Information

• Hyperlipidemia: 2–4 grams daily (divided doses). EPA:DHA ratio 1.2:1 or 1.5:1.
• Stop use before surgery to prevent reduced platelet aggregation.
• Echinacea may exacerbate asthma.
• Ginkgo biloba and seizure medication (e.g., Keppra) should not be combined.
• Sertraline and St. John's Wort should be avoided; combination can cause serotonin syndrome.
• Clopidogrel and ginkgo or saw palmetto should be avoided due to increased bleeding risk.
• CYP450 inhibitors/inducers; effect on drug action.

This quiz covers the regulations and guidelines surrounding dietary supplements, including the Dietary Supplement Health and Education Act (OSHEA). Explore the claims, safety measures, and special considerations for specific groups such as pregnant women and children. Test your understanding of the manufacturer responsibilities and FDA's role in supplement regulation.