How Products were Selected:
Products tested represent those commonly sold and/or available nationally in the U.S. ConsumerLab.com purchased products on the open market through retail stores, on-line retailers, and direct sales. Products were not accepted directly from manufacturers.Testing Methods:
- Quantification of picrocrocin, safranal and crocins (I-IV) by high performance liquid chromatography (HPLC). Methods were developed and validated in two separate independent laboratories based on the following references: N Li et al. J Chromatog A 1999, Aboli Girme et al. 2021, and M. Lage and C. Cantrell 2009.
- Analyses for lead, cadmium and arsenic were performed using Inductively Coupled Plasma-Mass Spectroscopy (ICP-MS).
- Disintegration of tablets (excluding chewable, sublingual and time-release formulations) utilizing United States Pharmacopeia (USP) <2040> recommendations entitled "Disintegration and Dissolution of Dietary Supplements".
ConsumerLab.com may modify or use other appropriate test methods if necessary to test special product formulations.
The identities of the products were not disclosed to the laboratories performing the testing.
Passing Score:*
To be "Approved" by ConsumerLab.com, a product must meet the following requirements:- Extracts are expected to provide a minimum of 0.002% (wt/wt of extract) of safranal, 0.45% (wt/wt of extract) of picrocrocin, and 0.24% (wt/wt of extract) of crocins I-IV (based on CL's analysis of commercially available extract raw material). Full approval also requires that amounts of safranal, picrocrocin, and crocin found must equal at least 80% of the amount listed for each, with an allowance that 45.47% of picrocrocin found may be counted toward safranal (based on the molecular weight of safranal within picrocrocin).
- Heavy Metals: Products must not exceed the following limits:
Lead:- Products marketed for use by children may not exceed the State of California's Prop 65 limits for lead in dietary supplements of 0.5 mcg per recommended daily serving with an additional allowance of 0.8 mcg if the product contains more than 1,000 mg/day of calcium.
- Products with single serving weights of less than 5 grams that are not marketed for use by children, may not exceed 0.5 mcg of lead per recommended daily serving (based on the State of California's Prop 65 limit for lead in dietary supplements, above which a warning is required regarding reproductive harm, birth defects, and cancer risks) with an additional allowance of 0.4 mcg if containing 250-999 mg/day of any combination of elemental calcium, magnesium and potassium or 0.8 mcg if containing more than 1,000 mg/day of any combination of these minerals. An additional allowance of 0.5 mcg is provided if containing 250-999 mg/day of whole herb (not extract) or 1.0 mcg if containing 1,000 mg/day or more of whole herb (not extract). However, total lead allowance will not exceed 2 mcg.
- Products with single serving weights of 5 grams or more which are not marketed for children may not exceed 2.5 mcg per serving nor 4.0 mcg per daily serving.
- If marketed for use by children, may not exceed 3.0 micrograms of cadmium per recommended daily serving (based on Canada's limit for a child weighing 75 lbs.). If not marketed for use by children, may not exceed 4.1 micrograms of cadmium per recommended daily serving (above which California's Prop 65 law requires a "reproductive harm" warning due to developmental toxicity and male reproductive harm).
- Contain less than 10 micrograms of total arsenic per daily serving (EPA limit and state of New Jersey limits — based on 1 liter of water). Products found to exceed this amount are tested for inorganic arsenic and must contain no more than 2.1 micrograms of inorganic arsenic per daily serving (Canada's limit in natural health products).
- Disintegration of tablets (excluding chewable, sublingual and time-release formulations) utilizing United States Pharmacopeia (USP) <2040> recommendations entitled "Disintegration and Dissolution of Dietary Supplements".
- Meet all FDA labeling requirements.
* Passing scores allow for specific margins of technical error associated with each analysis. ConsumerLab.com reserves the right to disqualify a product at any time from passing if it considers such product to display unacceptable variation in quality, present a safety risk or to provide misleading or inaccurate information in its labeling.
