I emailed the company that makes this melatonin product ("Quality Supplements and Vitamins, Inc.", dba, "LifeExtension"), twice, after purchasing and receiving this product, and discovering that no source was given on the bottle for the melatonin used in the product. They responded with what I would call a "public-relations"-type letter that did not, in my opinion, address my concerns. It appears to me that they intentionally tried to "snow" me with misleading statements that did not respond to my questions.
They attached a copy of their "COA" for this product that indicates that they perform tests for bacterial, fungal and heavy-metal contamination. This is probably sufficient, I believe, for testing samples of botanical materials, but is insufficient, I believe, for the testing of melatonin, or other drugs - which manufactured melatonin is. Melatonin, or any drug, should, in my opinion, be tested for purity and chemical contamination (which is the whole purpose of using "USP verified" materials). They argued, essentially, that because they are not required to do this by law, that it was unnecessary and just a marketing gimmick - I would say a very-good marketing gimmick.
They emphasized that they comply with "current Good Manufacturing Practices", which is a good thing, but is, in my opinion, misleading in this instance, as cGMP will do nothing to prevent the use of impure and chemically-contaminated drugs that may be used in compounding a product - even without the manufacturer's knowledge.
A pharmaceutical-grade compound is "a drug, biologic, or reagent that is approved by the Food and Drug Administration (FDA) or for which a chemical purity standard has been established by the United States Pharmacopeia-National Formulary (USP-NF) or British Pharmacopeia (BP)." Melatonin, as a manufactured product, is a drug. It is not "unfortunate" that some manufacturers meet this standard. In my opinion, if a company's melatonin does not meet this standard, it should not be sold for human consumption. Researchers, performing studies with animals normally require this standard for the products they use, to prevent the harming of their test animals. It is shocking, to me, that a company would show less concern to their customers, than researchers show to their test animals.
Consumer Reports states: "When you purchase any melatonin product (or any other dietary supplement, for that matter), make sure to look for the “USP verified” label. This seal indicates that the product has been subject to voluntary testing and meets US Pharmacopeia Convention standards (meaning the product is accurately labeled and free of harmful substances)."
Consumer Reports further states:
"Researchers from the University of Guleph in Ontario, Canada, tested 31 different melatonin supplements from 16 different brands. ... Here’s what they found:
"The actual melatonin content of those products ranged from 83% less to 478% more than the amount advertised on the label, with most products (21 out of 31) failing to fall within 10% of the label claim."
"Variability within individual products was also high; some products differed by as much as 465% in their melatonin content from one package to the next."
"Eight of the tested products also contained serotonin, a by-product of melatonin degradation that has its own medicinal effects and risks associated with overuse."
"... for most people, serotonin poses an even bigger risk. It's possible to overdose on very low levels of this chemical, the study's authors write. The condition is known as “serotonin syndrome,” and can range from mild (shivering and diarrhea) to severe (muscle rigidity, fever and seizures)."
I do not know if this company's product was included in this test - it may not have been, but the whole point is, if USP-verified melatonin is not used, we have no way of knowing if it is safe for consumption. If this company complies with cGMP standards, it would suggest that there should be uniformity from pill to pill in the dosage present, and that they have not themselves contaminated the product during the manufacturing process, but the quality and safety of the melatonin included is still not addressed.
This may be one great product, but without independent certification (through USP verification} of the melatonin they use, we have no way to know this. I've tossed my bottle in the trash to be safe, even though I am not one that likes to waste my money.
If what I've read on the internet is true, a lot of unsafe, even dangerous, drugs and chemicals are being manufactured in third-world countries, and imported to the United States for use by the largely-unregulated supplement industry. With so many companies, today, making the maximization of profits their only concern, why should anyone trust any manufacturer who considers the independent verification of the purity of the ingredients they use in their products as unimportant?
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From the manufacturer
Here’s To Living a Long and Happy Life.
Better Nutrition
40 years ago, we noticed something missing: people weren’t getting the nutrients that they needed—not even those that were taking their vitamins. So we set out to change that.
Higher Standards
We’ve spent decades redefining how to create advanced and effective formulations. The process is worth it: our supplements deliver the nutritional benefits promised.
Personal Wellness
Everyone’s needs are unique. Life Extension offers over 350 supplements, so you get the nutrition you deserve.
Dosage and Use
- Take one (1) tablet 30 to 60 minutes before bedtime, or as recommended by a healthcare practitioner.
- Melatonin is naturally secreted from the pineal gland at night, and should be taken at night.
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| Life Extension Melatonin 6 Hour Time Released Vegetarian | Life Extension Melatonin | Life Extension Melatonin | Life Extension Melatonin 6 Hour Timed Release | Life Extension Fast-Acting Liquid Melatonin | Life Extension Melatonin | |
| Bottle Count | 100 vegetarian tablets | 60 vegetarian capsules | 60 vegetarian lozenges | 60 vegetarian tablets | 2 fl oz | 60 vegetarian capsules |
| Dosage | 300 mcg | 3 mg | 3 mg | 3 mg | 3 mg | 10 mg |
Customer Questions & Answers
Customer reviews
If anything I am waking up more!
Reviewed in the United States on September 26, 2021
I was so excited to get this. After three nights taking it as directed, I am waking up more than before. What am I doing wrong? My granddaughter’s gummy 1mg melatonin sleep aides work better.
Reviewed in the United States on September 26, 2021
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