Prior to the introduction of the Thorne line of products in 1984, there were no truly hypoallergenic products available in the marketplace. Products were still produced as excipient-containing tablets or capsules containing potentially allergenic flowing agents and diluents. Physicians found something remarkable in the Thorne supplements they prescribed. Since they did not contain unnecessary diluents, sensitive patients no longer suffered bloating, nausea, and diarrhea from supplements that contained hidden lactose or other excipients. The offering of a complete product line of Thorne supplements made without magnesium stearate, palmitic acid, or stearic acid as flowing agents revolutionized the way a supplement’s performance was perceived. Why? By not coating each nutrient particle with a complete layer of saturated fat, nutrients are available to be immediately absorbed by patients who need the nutrients most – the digestive and immune compromised patient. Physicians now realize not only are Thorne Research products best for their “worst case” patients, but they work better for all patients.
There are four basic requirements for manufacturing a truly hypoallergenic product: 1. Actually being a manufacturer Thorne Research is a manufacturer, not just a sales or distribution company. The most important words to look for on any dietary supplement product label are “Manufactured By.” Thorne Research products are manufactured to exact specifications by our production staff, in our own state-of-the-art facility. Mixing and encapsulating are done in separate, sealed, individually-ventilated rooms with filtered air, to ensure there is no cross-contamination of materials. From the mixing of raw materials to packaging and labeling, numerous quality control checks are made before the finished product is released for sale.
2. Raw material choice To produce our truly hypoallergenic encapsulated supplements, we use only the purest raw materials available. Every manufacturer has two basic choices available for raw materials: purchase either truly pure raw materials, or purchase raw materials to which substances have been added to facilitate manufacturing. Typical choices every manufacturer must make are: purchase pure vitamin C or purchase vitamin C with additives; purchase pure B vitamins or purchase coated B vitamins for taste masking, purchase pure enzymes such as pancreatin, pepsin and bromelain, or purchase enzymes diluted with lactose.
3. Avoiding Unnecessary Ingredients Tablets must contain flowing agents, lubricants, binders, fillers, and disintegrants in order to be made into tablets. Encapsulated products are not free from these kinds of ingredients either. Lubricants such as stearic/palmitic acid, labeled also as magnesium stearate or calcium stearate, or sometimes ascorbyl palmitate are employed by almost all manufacturers, as are diluents such as lactose, dextrose, sucrose, and corn starch.
4. Quality Control Since 1984, Thorne Research has been dedicated to providing the practitioner with the best nutritional supplements in the world. As an adjunct to this mission, we utilize an in-house quality control laboratory, as well as outside, independent laboratories. Near-infrared spectrophotometry (NIRS), atomic absorption spectrophotometry, inductively coupled plasma technology, or high performance liquid chromatography (HPLC) are used to check every raw material purchased, every mineral we manufacture, and every finished product before it is released for sale. These items are assayed for purity, quality, heavy metals, and potency. Those materials that do not meet our rigid specifications are rejected. In addition, products are sent to an independent lab for microbial analysis, and fatty acids (including fish oils) are sent out for pesticide analysis.
Thorne manufactures to GMP (Good Manufacturing Practices) standards that exceed those currently proposed by the industry. These internal GMPs include written, stringent, standard operating procedures for every step of the manufacturing process, including (but not limited to) receiving raw materials, cleaning the manufacturing facility, material storage, product encapsulation, shipping, and quality control procedures. And since January 2000 our GMPs have been approved by the Australian Therapeutic Goods Association, the most stringent governmental health organization in the world.