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1. Status of Certain Additional Over-the-Counter Drug Category II and III Active Ingredients — final rule, 67 FR 31125U.S. Food and Drug Administration / Federal Register, 9 May 2002The rule reclassifying aloe and cascara sagrada for OTC laxative use to category II (nonmonograph), on the grounds of the lack of data and information and the failure of interested persons to submit any new data from carcinogenicity studies. Effective 5 November 2002.
2. SENNA LAXATIVE tablet — Drug Facts labelDailyMed, U.S. National Library of MedicineA current US over-the-counter senna label: sennosides 8.6 mg, purpose Laxative, and the warning do not use laxative products for longer than 1 week, unless directed by a doctor.
3. Aloe Vera: Usefulness and SafetyNIH National Center for Complementary and Integrative HealthFDA's removal of aloe latex from OTC laxatives, the abdominal pain and cramping from oral aloe latex, the acute hepatitis cases linked to oral leaf extract, the digoxin interaction, and IARC's classification of whole leaf extract as a possible human carcinogen.
4. Licorice Root: Usefulness and SafetyNIH National Center for Complementary and Integrative HealthGlycyrrhizin and its serious adverse effects, the risk in people with hypertension or heart or kidney conditions, and the four-month window for licorice without glycyrrhizin.
5. Milk Thistle: Usefulness and SafetyNIH National Center for Complementary and Integrative HealthThe thin evidence base for liver conditions, the two NCCIH-funded trials that showed no benefit, and the quality concerns about milk thistle supplements.
6. 21 CFR 101.36 — Nutrition labeling of dietary supplementsU.S. Electronic Code of Federal RegulationsThe rule that the label of a dietary supplement that is offered for sale shall bear nutrition labeling in accordance with this regulation, and the proprietary-blend rules on total weight and descending order of predominance by weight.
7. Health Products Compliance GuidanceU.S. Federal Trade CommissionThe competent and reliable scientific evidence standard, and the rule that consumer testimonials are never sufficient to substantiate claims about the effects of a health product.
8. Complying with the Made in USA StandardU.S. Federal Trade CommissionThe all or virtually all standard that a Made in USA claim has to meet.