The Dietary Supplement Health and Education Act of 1994 (DSHEA) has been an important and, of course, controversial rule released by the Federal Food and Drug Administration. After attempts to restrict supplement industry failed amid intense lobbying effort, FDA agreed to the proposal by Sen. Orin Hatch to provide guidelines for manufacturers and users of supplements. The bill was signed into law by President Clinton in 1994. The bill defines supplements as:
“A product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for use by man to supplement the diet by increasing the total dietary intake, or a concentrate, metabolite, constituent, extract, or combination of any of the aforementioned ingredients. Furthermore, a dietary supplement must be labeled as a dietary supplement and be intended for ingestion and must not be represented for use as conventional food or as a sole item of a meal or of the diet. In addition, a dietary supplement cannot be approved or authorized for investigation as a new drug, antibiotic, or biologic, unless it was marketed as a food or a dietary supplement before such approval or authorization.”
DSHEA required that supplement labels clearly reflect the ingredients, net weight, source of materials (including parts of plants), disclaimer that differentiates them from pharmacological drugs, and a safety disclaimer. Manufactures could put additional statements at their discretion.
The DSHEA drew criticism nearly immediately for not being restrictive enough. The fact that amount of vitamins or minerals in the supplements was not regulated prompted many to label them as ineffectual and wasteful.
It is true that many supplements have sketchy scientific evidence, and variations in their content make any attempt for evaluation difficult even when ingredients are the same.
At the ICCLI, our philosophy for supplement use is as follows:
- We will only recommend supplements that are manufactured domestically and are in compliance with the DSHEA.
- Supplements are purchased through our virtual dispensary from leading manufacturers that design medical grade formulations for use under physician supervision only. These are high potency formulations known to produce specified desirable effects in scientific studies.
- A detailed electronic prescription is generated individually for each patient, and is attached to their electronic medical record as well as available for personal record keeping. We encourage each patient to have their supplement prescription available for all of their doctor visits.
- A complete list of all active and inactive ingredients is available for all supplements, as well as information on their manufacturer.
- We ask that our patients sign an informed consent that explains uses and limitations of supplements.
Most importantly, the use of virtual dispensary allows Dr. Druz to pass her practitioner discount to her patients.
Feel free to contact us for more information. In further posts, we will explore use of supplements for various conditions, and highlight the most notable of the ingredients and how they can serve you on your way to optimal wellness!