Question
Peter Gillham’s Natural Vitality® Natural Calm, a powder, was found to contain 0.295 mcg of lead per teaspoon. It suggested a daily dose ranging from 1/2 teaspoon to 3 teaspoons per day which, at the higher end of the range, would exceed the State of California’s limit of 0.5 mcg of lead – above which a warning label is required. Such lead exposure can be easily avoided when taking magnesium, as evidenced by the many other products that did not exceed this limit.
I have good results with this product, but since reading this article have refrained from taking this supplement. Will your company investigate how lead was found in this product? What is defective in the manufacturing process to allow lead in this supplement?
Answer
For an update on this issue please see the most recent post
Thanks for writing us. We expect this issue to be resolved shortly. We saw the ConsumerLabs information two days ago.
First of all, we are not the manufacturer and this post does not represent their views. We are an independant company that happens to sell their products along with other health supplements.
We believe that ConsumerLabs are being alarmist and that Natural Calm is within 100,000 times the FDA safe zone and is totally safe. The rest of this blog is to substantiate that claim.
About ConsumerLabs
ConsumerLabs is not an actual laboratory, but contracts out their test needs to other labs. We have some questions about their testing accuracy and are in communication with them about the results. We are actually in the process of reviewing the data with them. ConsumerLabs is a company who wants members to subscribe. They also solicit for manufacturers to become members. If you are a manufacturer member and have bad results they treat you differently than if you are a non-member. We don’t believe that they are as independent as they try to lead us to believe. We have experience with lab analysis. Hair analysis is one method to detect mineral content in a person’s body. We know from experience it is very hard to obtain a lab that has a consistent reliable reading. My nutritionist regularly checks out his prefered lab to make sure that the results are consistent. One thing he does is send half the sample under one person’s name, and then he will send the other half as a different person. It took him many labs before he trusted one to make decisions based on the results.
ConsumerLabs uses 3rd party labs and from our experience, it is very hard to trust a lab sample. We believe it is in ConsumersLabs best interest to have results that are high so they can have sensational reports to sell. They are in the business to sell reports, not to protect consumers.
About the Lead Content
To put this in context, lead is found almost everywhere on earth - in air, foods, rivers, seawater, soils and even drinking water. The amount of lead in question is significantly less than would be found in many common foods. Our magnesium is sourced from sea water and sea water has many trace elements in it, including lead. If you analyzed the broccoli you eat, you would be able to pick up some lead in it and be able to report that in a test too. Even testing the air you breathe has a trace amount of lead.
We believe that Natural Calm is well within Federal FDA regulations with regard to naturally occurring lead content and have been following generally accepted industry guidelines for natural products within the state of California.
This is from the United States Pharmacopeia website with a date stamp of April 22 2009: Click here to see the chart.
USP 10 mcg per day based on 50kg body weight
EU 210 mcg/day; JECFA 210 mcg/day; FDA 75-25-6 mcg/day;Health Canada: 17mcg/day; ANSI 20mcg/day; California 15 mcg/day(for carcinogen; 0.5 for reproduction).
California just recently came out with very low standards. The FDA levels are 75mcg, and California is .5mcg, so 150 times less. Both of those figures are also “safe harbor figures” meaning, if you took 1,000 times that amount, you would still be safe. The UK is nearly 15mcg while other parts of EU get up to 210mcg. Canada is 17mcg and the US varies from 75 to 17mcg. So the new ultra low California standard is a brand new challenge that we will face and meet.
Let’s puts it into perspective…
If you took a sugar cube and divided it into 1,000 tiny cubes, then took a tiny cube and divided that into 1,000 and then split that in HALF, you would have half a microgram. We’re over by varying tests from .16 of a mcg to .38 of a mcg…so it’s a speck on a speck on a speck. Not the easiest task to keep at compliant levels; truly it’s an art. Tests vary from batch to batch, and we will work towards ensuring that every batch will meet the new California standard.
The recommended serving size (3 teaspoons) is 50% more than the RDA because we believe that most people will benefit from a higher dose. If you took the RDA serving size, Natural Calm would be within the ultra low California only limit. ConsumerLabs could have pointed that out, but being an alarmist company, we believe that they like to instill fear to sell reports and they prefer to be sensational.
Apparently more 350 products were black-listed on their magnesium list. Most were up to 50 times the legal amount. We Natural Calm was over by just .16 and we are not sure that Natural Calm really is over by the .16.
So in conclusion, Natural Calm is very safe in regards to lead levels and the company is working on reducing the lead further to be consistently below the new ultra low California standard.
Here is the company’s official statement
We saw the ConsumerLabs information two days ago. ConsumerLabs is not an actual laboratory. They contract out with other labs. We have some questions about
their test and are in communication with them and we are reviewing the data.
To put this in context, lead is found almost everywhere on earth - in air, foods, rivers, seawater, soils and even drinking water. The amount of lead in question is significantly less than would be found in many common foods.
We are well within Federal FDA regulations with regard to naturally occurring lead content and have been following generally accepted industry guidelines for natural products within the state of California.
We expect this issue to be resolved shortly.
For an update on this issue please see the most recent post