California Prop 65
Charak Pharma: A legacy of trust
Charak is one of the pioneers in the field of manufacturing ayurvedic/herbal supplements. Charak has relentlessly provided research-based, scientifically validated herbal products by tapping the wisdom of the ancient Indian system of medicine- Ayurveda. Charak comes to you from a country and a culture revered for its ancient Ayurvedic knowledge and modern medical infrastructure. The ISO 9001:2008 certified company derives its name from the sage Charak who was the foremost authority in Ayurveda in 1000BC.
We take the pride to announce our self as “WHO-GMP” certified company, which is the symbol of highest quality of manufacturing standards of ayurvedic/herbal supplements. Our products are renowned for their adherence to international standards of quality and hygiene and are manufactured under strict regulations of contemporary measures of production. Charak brings to you well-researched, tested health solutions proved effective for users across continents, to support disease conditions and enhance your lifestyle.
We at Charak are totally committed to uncompromised standards and reproducible, predictable results. The quality standards and efficacy of products have been reaffirmed through stringent quality checks, extensive research and numerous clinical trials. This experience and expertise help us bring to you products that provide natural support in various chronic lifestyle disorders. Our Innoveda range of herbal supplements consists of clinically tested and individually standardized extracts which are GRAS (Generally Recognized As Safe) and CFR (Code of Federal regulations) compliant.
Various herbs occurring in nature contain very low levels of lead which may elicit the requirement to warn. Lately you may have noticed the California Proposition 65 warnings on our product labels and bills, we urge you to stay rest assured as our products continue to be safe. These warnings have been added so that we can continue to serve you in the state of California while ensuring compliance with Proposition 65.
Proposition 65 questions the amount of lead – an element that is commonly found in soil, plants as well as water amongst many other things. These naturally occurring herbs/plants commonly used in ayurvedic/herbal supplements might be the source of lead. Charak does not add lead or any other harmful ingredients in any of the products.
Proposition 65 also states that a warning would be required for any product wherein a person ingests more than 0.5 micrograms of lead during the course of a day. This is an extremely low level that is, by law, close to a 1000 times lower than exposure that has proven to be detrimental, setting the law to be one that is extremely stringent on the warning threshold.
See below for more information regarding Prop 65 labeling.
Do Charak products follow the standards & regulations for safety?
Charak Pharma is a WHO-GMP and ISO certified organization. Our products are renowned for their adherence to international standards of quality and safety, while our manufacturing facilities are cutting-edge and highly automated. Our products are well within the permissible limits for heavy metals, pesticide residues and microbial contamination, measured against the standards set by international regulatory agencies.
Why do Charak Products carry Prop 65 (Proposition 65) warning?
We are committed to continue serving our customers in California, and therefore our invoices and product labels follow the California Proposition 65 warning guidelines. This warning is to ensure compliance with the State of California’s unique labeling law Proposition 65, which applies to certain chemicals identified by California to cause cancer and reproductive toxicity. As per the law, businesses selling products into California have to notify consumers of the presence of any Prop 65 listed chemicals, if they exceed certain levels.
Most Important: The chemicals listed in Prop 65 are never added by us to our products, but are found commonly in soil, plants, and water or can naturally occur in the raw materials used for manufacturing. Charak Pharma follows rigorous examination and testing at all stages, from procurement of raw materials up to finished products.
What is Prop 65?
California’s Proposition 65 (commencing with section 25249.5 of the California Health and Safety Code) requires that producers, manufacturers and retailers of certain products provide customers with special warnings, if their products contain chemicals known to the state of California to cause cancer, birth defects or other reproductive harm. This warning is required if the consumer is exposed to these chemicals in concentrations above certain thresholds.
What is the background of the Prop 65 law?
Proposition 65 was approved in 1986 to “protect California citizens and the State’s drinking water sources from chemicals known to cause cancer, birth defects or other reproductive harm, and to keep citizens informed about exposure to such chemicals.” The state maintains a long list of chemicals (http://oehha.ca.gov/proposition-65/proposition-65-list) that are known to cause cancer or reproductive toxicity. It is essential to note that some of these chemicals can exist naturally in the earth, soil, and water as a result of geologic deposits.
How stringent are the levels defined by Prop 65?
The levels defined by Prop65 are stricter than those defined by any other regulatory body or authority. For example, the warning level for lead, a reproductive toxin, is 1,000 times lower than even the highest level known not to cause harm! Simply put, the Prop 65 law is 1,000 times more cautious than required to protect you from health effects.
What are the other national and international standards for lead exposure as compared to Prop 65?
As mentioned earlier, Prop65 is far more stringent even when compared to other regulatory agencies like the FDA or the WHO. And when it comes to lead, the difference in permissible levels is huge. The Prop 65 level for lead is actually 1,000 times less than the level found to have no observable effect on humans or animals.
Standards for lead set by State and Federal Regulatory Agencies
|NSF International limit for lead (mcg/day, orally)||20 mcg|
|California Proposition 65 cancer limit for lead||15 mcg/day|
|World Health Organization lead limit||10 mcg/day|
|United States lead limit for pharmaceuticals||3 mcg/day|
|California Proposition 65 reproductive toxin limit for lead||0.5 mcg/day (0.5 parts per million)|
I don’t reside in California. Why do the products I purchase have the Prop 65 warning?
Charak Pharma products are available across the USA, through distributors and e-stores. To maintain uniformity for our products across the country, we follow the standard label and packaging requirements based on regulations, including Prop 65.
Where can I get to read more about Prop 65?
You can visit http://www.oehha.ca.gov/prop65.html, an official website maintained by the California Office of Environmental Health Hazard Assessment for more details.