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The U.S. has widespread regulation for all non-prescription and prescription drugs courtesy of the FDA (Food & Drug Administration). However, treatment of dietary supplements is more on the lines of special foods. Since supplements are not taken as drugs, they do not go through the same requirement-related mechanisms. Drugs are taken to be unsafe by the FDA until they are proven to be completely safe via clinical trials. New drugs are to be approved by the FDA prior to being legally sold in the U.S. Clinical trials are done in suitably controlled circumstances on human volunteers. These are mandatory for all types of drugs, including those sold over the counter. Post FDA approval, it should be produced under conditions which are monitored and packaged with all vital data regarding the best route, dose and schedule. The package information should include the conditions treated by the drug, known side effects, unsafe interactions with other drugs and contraindications.
The 1994 Dietary Supplement Health and Education Act or DSHEA has defined dietary supplements as a food category governed by varying regulations as compared to drugs. They are safe until proven unsafe. The DSHEA states that supplements cannot have anything with a significant or unreasonable risk of illness or injury. A dietary supplement is taken as new if it has an ingredient without recognition as a food substance, unless it was sold as a supplement prior to October, 1994. For those which are new supplements, the FDA should get proper evidence of the ingredient being safe, prior to marketing to the general public. Manufacturers do not have to test supplements or ingredients via clinical trials although the FDA can stop companies from making supplements after proving that they cause major health risks.
Another difference is that dietary supplements are mostly self-prescribed and hence there is no controlled mechanism for reporting of side effects and bad reactions. Patients and doctors may report problems although they do not have to mandatorily do this. Nutritional supplements are intended majorly as additions to diets and they are regulated in some countries with varying paradigms. The maximum and minimum limits for supplements are widely published by leading regulators as falling in the safe threshold in terms of specific elements and components. For instance, the maximum limit for Vitamin C was deemed 200 mg by the acclaimed study by Ristow et al. Regulations vary from one country to another. For instance, products with vitamins higher than the maximum threshold are available in Norway although they are classified as prescription-free drugs and are intended to be used over a restricted time period in consultation with a doctor for vitamin deficiency treatments. This is different from regular nutritional supplements which are usually additions for diets over a sustained duration.
Sweden does not have any maximum limit regulations and nutritional supplements here may contain far bigger nutrient doses. The recommended intake daily may differ from the values used in the U.S. and also in Norway. Nutritional supplements may have nutrients that can be ingested via a healthy diet. AS per regulations it is not legal to claim or give the impression that a balanced diet will not offer ample supply of minerals and vitamins. This is a legal regulation for supplements. The Directorate of Health has also defined recommended intake for multiple nutrients, minerals and vitamins. If the diet does not provide this recommended consumption amount, then nutritional supplements may increase their levels in the body while combating against deficiency-linked symptoms.