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February 5, 2015
Dear Valued Practitioner,
There have been a number of recent items in the media regarding dietary supplements. Most recently, the media has reported on the New York Attorney General’s office delivering cease and desist letters to four major retailers – Target, GNC, Walgreens, and Walmart – to stop selling certain dietary supplements. The action in New York was taken in response to an investigation conducted by the Attorney General in which 78 bottles of popular botanical supplements were obtained off the shelves of these retailers and subjected to DNA barcoding analysis. This analysis has been claimed to determine that many of the sampled products contained ingredients other than those listed on the label, and in some cases, revealed the major ingredients cited on the label were not present in the product.
The action by the New York Attorney General reconfirms the importance of testing for and affirming the “identity” of botanical ingredients by dietary supplement manufacturers as part of their adherence to Good Manufacturing Practice (GMP) regulations required by the U.S. Food and Drug Administration. The apparent failure to do that in the instant situation should serve as a sharp reminder to any supplement manufacturer that is cutting corners by omitting routine laboratory analysis; for example, only using “organoleptic testing” as their method of confirming plant identity, or, worse, knowingly marketing substandard or substituted products.
In the absence of all the facts being known, it is not fair to jump to a conclusion regarding the merits of these actions taken by the New York Attorney General. Having said that, Thorne Research wants to assure you of the integrity of the products that we manufacture and distribute, and the actions we to take to ensure consistency between what is on the product label and what is in the bottle.
In order to assure consistency and the integrity of our products, we have developed and implement detailed and documented specifications for all raw materials, production components (such as bottles and lids), labels, and finished products. We source raw materials and components only from the best suppliers who are certified by us to meet our requirements and consistently provide materials that comply with our stringent specifications.
Thorne Research’s standards for testing raw materials and finished products meet or exceed the standards set by both the U.S. Food and Drug Administration and the Australian Government’s Therapeutic Goods Administration (Australia’s FDA), thus providing worldwide governmental acceptance of our products. Every raw material and finished product is tested for microbiological contaminants, heavy metals, and other reasonably expected environmental contaminants.
Thorne Research’s nutritional supplement products are recognized worldwide for their excellence in purity, consistency, and quality in manufacturing. This reputation is in large part due to the rigorous quality management and testing standards we adhere to before, during, and after the manufacture of each of our products. One out of six Thorne Research employees are directly involved in overseeing these standards. We devote over five percent of our revenues to laboratory testing of our ingredients and products.
Thorne Research’s in-house quality control laboratory and select third-party laboratories perform our precise testing methodologies to consistently:
- Identify all known pathogens and other reasonably expected contaminants that might pose a health risk to the users of our products.
- Verify the identity, potency, and purity of each ingredient listed on the product label.
- Provide timely and transparent testing information on every product.
- Ensure the integrity of each supplier in our supply chain.
We accomplish these objectives by conducting testing that utilizes state-of-the-art testing equipment that is operated by trained and experienced in-house and third-party chemists, microbiologists, and laboratory professionals for:
- Microbiological contaminants: Testing that screens for the presence of microbial contamination or overgrowth.
- Expected contaminants: Testing that screens for contaminants reasonably expected to be present based on the ingredient being tested; for example, pesticides in botanical extracts and heavy metals in fish oil.
- Ingredient Analysis: Testing that confirms the identity, potency, and purity of the raw material; for example, analytical testing to confirm the identity of a raw material is what it should be – as well as the concentration and intensity of the active ingredient.
Thorne Research tests every raw material for identity, meaning the specific components included, and how much of each component is present before any item is released for manufacturing. Every botanical, vitamin, mineral, amino acid, oil, and nutrient ingredient that we receive in our manufacturing facility is quarantined and not released for production until it has been tested and its identity has been confirmed. Unless this testing conclusively demonstrates the correct ingredient and its respective properties for a particular product, the material will not be used in production. This testing is conducted in our state-of-the-art in-house laboratory, and qualified independent third-party testing laboratories. Some of this testing can take as long as three weeks. In addition, we also test for microbiological contaminants, heavy metals, and other expected contaminants; for example, pesticides in botanical ingredients, before releasing raw materials to production.
During manufacturing we conduct testing to ensure homogeneity in the mixing of the ingredients to ensure that each capsule will contain the amount of each ingredient stated on the label. We do not dilute any raw material with preservatives and no hidden ingredients are included. What is on a Thorne Research label is what is in the bottle.
Following production, and before a product is released for sale, each product is again tested for the identity of its labeled ingredients, the respective potency and purity of these ingredients, and for any risk of microbiological contamination. In other words, the finished product is tested to meet its label claim and to ensure the purity, quality, and safety of the product and its ingredients as required by Thorne Research and the GMP regulations imposed by the U.S. Food and Drug Administration. In addition, Thorne Research conducts stability testing to make certain that the ingredients in the product remain “active” throughout the product’s expiration period.
We at Thorne Research take great pride in manufacturing pure, safe, and efficacious dietary supplement products. We can’t comment on what other manufacturers do or don’t do, because we don’t know, but we want you to know what we do, so you may have the utmost confidence in our products.
Thorne Research | 800-228-1966 | firstname.lastname@example.org | http://www.thorne.com
25820 Highway 2 West
PO Box 25
Dover, ID 83825
25820 Highway 2 West
PO Box 25
Dover, ID 83825
Chief Executive Officer
Thomas P. McKenna
Chief Operating Officer