Fda Dietary Supplements
As per the law a dietary supplement is defined as a product which is meant to supplement the diet of a person and should have at least one dietary ingredient like vitamins, amino acids, minerals and so on. The product can either be in a solid form like a tablet, pill or capsule, or in a liquid form, and should be clearly labeled as a dietary supplement. This definition is clearly mentioned in the DSHEA (Dietary Supplement Health and Education) Act of 1994. The U.S. Food and Drug Administration (FDA) regulates all foods, drugs and dietary supplements. The regulation policies are different for each of these items and for a product to be legally called a dietary supplement FDA has laid down certain rules.
FDA recognised dietary supplements cannot claim on their labels that the product can either cure, treat, mitigate, diagnose or prevent a disease. The claims on the label has to be limited to only health, function, structure, and/or nutrient. The claim on improved health can describe the relation between an ingredient in the dietary supplement and how it can reduce the risk of getting a particular disease or any other health related problem. The nutrient claim can give the amount of nutrient content in the product, and its relative value for everyday usage. The function and structure claim can describe how the ingredients in the product are going to affect the different systems or organs in the body. But it cannot claim any cure for a specific disease. FDA does not have to approve the function/structure claim but the producer of the dietary supplement must give a copy of this claim to the FDA within a month of the launch of the product, and must include a disclaimer statement on the label that says FDA has not evaluated the claim, and the product does not diagnose,cure, treat or prevent any disease.
Apart from regulating the claims on labels of dietary supplements, the FDA also takes other measures to regulate these products. For all dietary supplements launched after 1994, the manufacturer must inform the FDA of the new launch and also give a report about the new ingredient in the dietary supplement and reasonable proof that the product is fit and safe for human consumption. Although submitting this proof is not mandatory, FDA has the power to remove a dietary supplement product from the market after proving that it is unsafe.
As per the law a dietary supplement is defined as a product which is meant to supplement the diet of a person and should have at least one dietary ingredient like vitamins, amino acids, minerals and so on. The product can either be in a solid form like a tablet, pill or capsule, or in a liquid form, and should be clearly labeled as a dietary supplement. This definition is clearly mentioned in the DSHEA (Dietary Supplement Health and Education) Act of 1994. The U.S. Food and Drug Administration (FDA) regulates all foods, drugs and dietary supplements. The regulation policies are different for each of these items and for a product to be legally called a dietary supplement FDA has laid down certain rules.
FDA recognised dietary supplements cannot claim on their labels that the product can either cure, treat, mitigate, diagnose or prevent a disease. The claims on the label has to be limited to only health, function, structure, and/or nutrient. The claim on improved health can describe the relation between an ingredient in the dietary supplement and how it can reduce the risk of getting a particular disease or any other health related problem. The nutrient claim can give the amount of nutrient content in the product, and its relative value for everyday usage. The function and structure claim can describe how the ingredients in the product are going to affect the different systems or organs in the body. But it cannot claim any cure for a specific disease. FDA does not have to approve the function/structure claim but the producer of the dietary supplement must give a copy of this claim to the FDA within a month of the launch of the product, and must include a disclaimer statement on the label that says FDA has not evaluated the claim, and the product does not diagnose,cure, treat or prevent any disease.
Apart from regulating the claims on labels of dietary supplements, the FDA also takes other measures to regulate these products. For all dietary supplements launched after 1994, the manufacturer must inform the FDA of the new launch and also give a report about the new ingredient in the dietary supplement and reasonable proof that the product is fit and safe for human consumption. Although submitting this proof is not mandatory, FDA has the power to remove a dietary supplement product from the market after proving that it is unsafe.
No comments:
Post a Comment