Supplement Manufacturing 101

What Are Dietary supplements?nDietary supplements are products that contain one or more dietary ingredients such as vitamins, minerals, herbs or other botanicals, amino acids or other ingredients used to enhance the diet. In the United States, dietary supplements are available in a wide range of product forms, such as tablets, capsules, powders and liquids. More than 70 percent of the U.S. population use dietary supplements as a safe, effective and affordable way to maintain good health and fill the nutritional gap in their diet.nnHow FDA Regulates Dietary Supplementsnnlike pharmaceutical manufacturers, dietary supplement manufacturers have no formal quality control regulations or inspections. Built into DSHEA (Dietary Supplement Health and Education Act) are important provisions that promote the safety and efficacy of dietary supplements. Any company wanting to manufacture dietary supplements should know specifically that DSHEA:

• Gives the U.S. Food and Drug Administration (FDA) the authority to protect the public from any unsafe products. The FDA reserves the right to recall any product at any time if the agency believes it is a health risk.
• Granted FDA the ability to establish guidelines called Good Manufacturing Practices (GMPs) to hold dietary supplement manufacturers to a high standard of safety.
• Requires truthful labeling and claims for dietary supplements. All dietary supplements are required to adhere to standard labeling procedures by listing the names and quantities of each ingredient and identifying the product as a dietary supplement directly on the packaging. Additionally, any nutritional claims must be proven, and manufacturers must notify the FDA in advance. Manufacturers can circulate other materials, such as articles and pamphlets, to consumers as long as the information is accurate and not misleading.

nnThings to Prepare before Shopping for a Supplement Manufacturer Study a list of manufacturers available. Shortlist those manufacturers who choose to be licensed by the FDA and state pharmaceutical licenses. These facilities must meet or exceed the stringent protocols and Good Manufacturing Practices (GMPs) established for the pharmaceutical industry.nWork with a company that can assure you of a high level of quality control.nnProcessing TechniquesnKeep in mind that the quality of the dietary supplement is the responsibility of manufacturers, and comes down to purity of raw ingredients. Large, established manufacturers are said to grow their own botanicals, but, many of these companies actually contract with growers instead. Much of the industry relies on outside suppliers, which may result in sub-standard raw materials. Consistent in-house testing by the manufacturer will ensure the highest quality is being used. Heat destroys many nutrients, particularly enzymes. A supplement manufacturer should guarantee all products are formulated in the cooler temperature ranges or "cold process" nutrients to preserve nutritional potency. Mutagenic chemical solvents should not be used. A common tablet coating used is "shellac". This coating often results in the phenomenon known as "bedpan pills", products which transverse the gastrointestinal tract intact. Binding agents, like ethyl cellulose, are not good. They render nutrients unavailable for absorption. Chemical binding agents are never used in a superior bioavailable product. Many nutritional supplement industries use these techniques to mass manufacture vitamins to increase profit margins and reduce costs. It is better to use "aqueous coating" and biopotentiation technique using bioflavonoids which allows for maximum disintegration and dispersion. Every batch should be checked for purity, potency and efficacy. Final products should be subjected to rigorous disintegration and dissolution testing. Study the vitamin manufacturer you are intending to use. Make every effort to ensure that you will get a quality product that will actually bring the intended health benefit to the consumer.