Health & Wellness

FDA Labeling

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Good Manufacturing Practices

Dietary supplements are considered foods and are subject to requirements of "Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food" (108). These regulations provide guidelines with regard to maintenance of buildings and facilities, requirements for food handlers, and cleanliness of equipment, as well as procedural requirements for maintaining safety during the production and processing of foods. This requirement is very similar to the same one used for regular food handling or labeling.

DSHEA specifically authorizes FDA to establish dietary supplement GMPs. Recognizing this perceived need, major industry groups in 1995 jointly prepared extensive revisions to the food GMPs that address aspects of manufacturing practices used by the dietary supplement industry. These proposed GMPs for dietary supplements were submitted to FDA and subsequently published as an ANPR in the Federal Register (32). The Commission supports these efforts of FDA and the industry to develop appropriate GMPs for dietary supplements.

Some Supplement companies choose to voluntarily adhere to the Pharmaceutical Standards. This is the same standard that is applied to the production of drugs. There are two significant differences between these standards:

bulletQuality of ingredients is at a much higher standard. Drugs cannot be contaminated with other substances particularly in the raw material stage.
bulletThe label requirements are totally different. Food labels do not have to actually describe the ingredients accurately. Pharmaceutical standards do not make it an option. What is on the label must be in the product. 

Does the labeling requirement make a difference?

bulletIn one study, the amount of glucosamine contained in 14 commercially available glucosamine products varied from 41% to 108% of the amount stated on the label. Even when the weight of the sulfate molecule was included, 11 of the 14 products contained less than the amount of glucosamine stated on the label. Some manufacturers may include the weight of the stabilizing salts (NaCl or KCl) in the total weight of the product, without stating so on the label.(1)

Purchase your supplements from companies that follow the pharmaceutical standards to ensure what in on the label in in the product.




(1) Healthnotes, Inc.

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These statements have not been evaluated by the Food and Drug Administration. This web page or any products found here are not intended to diagnose, treat, cure, or prevent any disease. If you find information here that is of interest to you, take it to your medical doctor for conversation and evaluation. Do not stop taking any prescription drugs without consulting with your medical doctor.

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