February 5, 2015
Dear Jarrow Formulas Customer,
Jarrow Formulas is committed to producing the highest quality dietary supplements through a “Total Quality” multilevel approach so that customers can have the upmost confidence and trust when using Jarrow Formulas’ products.
All Jarrow Formulas products are manufactured in Current Good Manufacturing Practices (cGMP) certified facilities. These regulations govern the manufacturing, storing, labeling and distributing of ingredients and finished products as they transit the supply chain. Under the cGMP regulations, manufacturers are required to evaluate the identity, purity, strength and composition of both ingredients and finished products to ensure that products are accurate and meet specifications. Moreover, the vast majority of our products are manufactured by our sister company, Jarrow Industries, a state-of-the-art cGMP certified factory featuring pharmaceutical grade equipment and levels of quality control.
Jarrow Formulas invests significant time in qualification and ongoing auditing of raw material suppliers to ensure only the purest ingredients are used in Jarrow Formulas’ products. Both Jarrow Formulas and Jarrow Industries have dedicated quality control teams that follow standard operating procedures outlining stringent inspection processes of incoming as well as outgoing products. High performance thin layer chromatography (HPTLC; FDA recommended methodology) is performed on all incoming botanical materials to confirm unadulterated ingredient identities using verified botanical reference material (prior to use in manufacturing. Jarrow Industries tests manufactured products by lot (e.g., capsules/tablets) to verify active ingredients prior to packaging (e.g., bottling, blister packaging); furthermore, Jarrow Formulas contracts cGMP certified laboratories to test packaged, finished product lots to confirm ingredient specifications prior to distribution for sale.
In summary, customers can be assured that any product that bears the name Jarrow Formulas has gone through our extensive “Total Quality” multilevel approach to ensure products are safe and efficacious.
Jarrow Formulas® Means Total Quality
Jarrow Formulas focuses on manufacturing and marketing the highest quality dietary supplements in a thorough process the company calls “Total Quality.” As the name suggests, Total Quality encompasses every aspect of the business: regulations, quality control, laboratory testing, formulation, sourcing, and marketing of products.
Most of Jarrow Formulas’ products are manufactured by its sister company, Jarrow Industries. Jarrow Industries is a high-speed, state-of-the-art factory that features pharmaceutical levels of quality control, with many of the machines found in pharmaceutical manufacturing environments.
Jarrow Formulas invests a significant amount of time in both the new vendor qualification processes and the ongoing auditing of existing vendors to ensure that only the purest ingredients are allowed into Jarrow Formulas’ products.
Both Jarrow Formulas and Jarrow Industries have dedicated quality control teams that follow strict inspection processes of incoming and outgoing products. All products are tested by third-party labs that are ISO and USDA accredited. The labs utilized all adhere to the strict cGMP/GLP guidelines set forth by the FDA.
Jarrow Formulas takes great care in formulating products that include efficacious dosage levels. The company’s R&D professionals are continually evaluating the latest clinical research to ensure Jarrow Formulas’ products are appropriately up-formulated®.
The Federal Trade Commission (FTC) has very clear advertising guidelines requiring any claims made by marketers be reasonably substantiated. Jarrow Formulas is conservative in the statements it makes to ensure all claims are within FTC advertising guidelines.
The United States Food and Drug Administration (FDA) regulates the dietary supplement industry. While it is true that the FDA does not give pre-market approval to dietary supplement products as it does pharmaceutical products, the agency does have the complete ability to regulate both products and companies.
The Dietary Supplement Health and Education Act of 1994 (DSHEA) is one of the key regulatory frameworks governing the dietary supplement industry. Under DSHEA, dietary supplement manufacturers bare the burden of ensuring products and ingredients are safe for public consumption, while the FDA is responsible for taking action against products that are deemed unsafe. DSHEA also sets forth labeling standards that require ingredients be clearly labeled in the form of a supplement facts panel specifying the total net amount of active ingredients the product contains.
Dietary supplement companies are also regulated by Current Good Manufacturing Practices (cGMP). These regulations govern the manufacturing, storing, labeling and distributing of ingredients and finished products as they transit the supply chain. Under the cGMP regulations, manufacturers are required to evaluate the identity, purity, strength and composition of both ingredients and finished products to ensure that products are accurate and contaminate free.
Jarrow Formulas strictly adheres to California’s proposition 65, also known as the Safe Drinking Water and Toxic Enforcement Act of 1986. Proposition 65 was originally designed to set forth safe levels of exposure to toxins, including heavy metals, that are known by the state of California to cause birth defects or other reproductive harm. This list has now grown to over 800 chemicals. If one of these chemicals is present within a product above the proposition 65 standard, businesses are required to provide a warning on the label. The level of safe exposure is determined first by finding the “no observable effect level,” and then dividing that level of exposure by 1,000. This extra step of dividing by 1,000 creates an abnormally low threshold.
Proposition 65 requires any foods or nutritional supplements that exceed 0.5μg of lead per daily serving to have a warning label that states:
WARNING: This product contains chemicals known to the State of California to cause cancer and birth defects or other reproductive harm.
Lead is a ubiquitous metal. It is present as a naturally occurring mineral throughout our natural environment, including in the air, soil and water. When plants and other food ingredients grow, they take up trace amounts of lead from even the most pristine ecosystem. Almost all naturally occurring foods and food materials inevitably contain small amounts of lead. For example, one serving of canned fruits contains 4.5μg of lead while a glass of wine contains 1.75μg on average. These values represent 9 and 3.5 times, respectively, the daily limit imposed by Proposition 65. According to Proposition 65, these food items that contain more than 0.5μg of lead per daily serving are required to have a warning label although we often do not see it on the items.
Many experts have taken issue with the lead limit in Proposition 65 limit, because it was set unreasonably low for most foods and nutritional supplements and the law is applied unequally. Even compared to other global regulations, the limit seems to be particularly low. For example, the World Health Organization allows 3.57μg/kg body weight/day of lead, which is equivalent to 250μg/day in an average adult. This allowance is 500 times higher than the Proposition 65 daily limit. Other countries, such as Japan, Australia, Germany, and Canada allow anywhere between 10-20 times more lead intake (5-20ppm in foods and/or nutritional supplements) than the amount that Proposition 65 allows. Moreover, a different standard is applied to foodstuffs than to identical materials that merely have had all moisture removed and been reduced to supplement form. For instance, a bowl of leaf lettuce that contains 1.6 times the Proposition 65 lead limit does not require a warning, whereas the same lettuce dehydrated and placed in a powder or in tablets does require such a warning.
The Jarrow Formulas’ supplements that list the mandatory Proposition 65 warning label contain anywhere between 0.5-5μg per daily serving of lead, which is within the range commonly found in other food and food ingredients. Moreover, these quantities are often lower than similar products provided by other major dietary supplement companies. The contents are well below the limits set by other national and international regulatory agencies. Jarrow Formulas takes proposition 65 very seriously and formulates products that, in most cases, meet these levels. This strict level of attention to safe levels of toxic exposure supports the Jarrow Formulas mantra of Total Quality.
The entire Total Quality process is reinforced by a set of strict Standard Operating Processes (SOPs) that are present at both Jarrow Formulas and Jarrow Industries ensuring accurate, consistent and supportable products.
Customers can be assured that any product that bears the name Jarrow Formulas has gone through an exhaustive Total Quality process to ensure products are safe and efficacious.