- Look for ingredients in products with the U.S.P. notation, which indicates the manufacturer followed standards established by the U.S. Pharmacopoeia.
- Consider the name of the manufacturer or distributor. Purchase supplements made by a nationally known food and drug manufacturer, who would likely have in place tight quality control manufacturing standards for their other products.
- Write to the supplement manufacturer for more information. Ask the company about the conditions under which its products were made. This is also a good opportunity to request references about scientific studies to substantiate any labeling claims you have questions about.
Recommendations for Use
- Don't hesitate to tell your physician if you are considering an alternative or complementary medicine treatment. Work with your with your physician to find out more about dietary supplements that may improve your blood glucose control and overall health.
- Monitor your blood sugars more frequently when introducing dietary supplements into your regimen that may have glucose lowering effects. Start off by taking less than the prescribed daily dose to find out if the supplement has any effect on your blood sugars. Call your physician or diabetes educator about making the necessary adjustment in your medication.
- Consider how an alternative remedy may interact with prescription or over-the-counter drugs you are already taking. Some combinations may be dangerous.
- Be wary of expensive, unproven products. Watch out for hype and fraudulent claims. Avoid purchasing products that are claimed to be “secret, magical, or miracle cure”, a “scientific breakthrough”, or “new discovery”.
- Buyer Beware! Realize that the label term “natural” doesn't guarantee that a product is safe.
- Do not stop taking your prescribed oral medications or insulin because you believe that a natural product will lower your glucose level. Dietary supplements should be used to complement existing therapies and to enhance overall regimen. They are not drugs and are not meant to be used as a replacement for your usual diabetes medication.
- Dietary supplements are not replacements for conventional diets since they do not provide all the known and perhaps unknown nutritional benefits of food. Recognize the benefit of taking supplements is to provide dosages which are higher than would normally be obtained from eating food alone. For example, the amount of chromium in the American diet is only about 25 mcg whereas the recommended dosage for diabetes to have any potential benefit would be between 200mcg-1000mcg daily.
- Dietary supplements should be used as an adjunct to your diabetes regimen and therefore other aspects of meal planning, exercise, or daily medication should not be changed.
- Be Your Own Advocate: Learn as much as you can about the dietary supplements you are taking by talking to your physician, contacting a Registered Dietitian or Registered Pharmacist, looking up industry information on the internet, and writing to manufacturers to request relevant clinical research data in diabetes . Check to see if the research studies include subjects with either type 1 or type 2 diabetes (or both) to determine whether the supplement may help you. Often studies showing efficacy in lowering blood glucose levels are only relevant in type 2 diabetes since the mechanism of action of many supplements is to enhance insulin secretion or decrease insulin resistance which does not benefit the individual without insulin secreting beta cells that characterizes type 1 diabetes.
- Pregnant women, nursing mothers, and children are advised not to experiment with taking dietary supplements.
What kinds of Claims Can Be Made For Supplements?
Federal law currently allows supplements to make truthful claims that they maintain the healthful “structure or function” of the body- but they may not state they can be used to treat diseases or make any therapeutic claims. The FDA recently eased some restrictions on dietary supplements-now permitting products to legally claim to treat a variety of symptoms that are part of the normal life process (eg, conditions such as morning sickness, menopause, and memory loss.). Direct linkages to diseases and serious symptoms are still off-limits for supplements and will remain so unless such claims can be supported with clinical research data.
What's On the Label?
Information that is required includes:
- The words “dietary supplement” must appear on the label
- Statement of identity (eg, “ginseng”);
- Net quantity of contents (eg “60 capsules”)
- If there is a structure-function claim , the following statement must appear :“This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”
- Directions for use (eg, “Take one capsule daily”)
- Supplement Facts panel (lists serving size, amount, and active ingredient); in many cases contents and potency are not accurately listed on the label.
- Other ingredients in descending order of predominance and by common name or proprietary blend
- Name and place of business of manufacturer, packer or distributor. This is the address to write to for more product information.
Quality of Ingredients
Since herbs are not regulated as drugs, no legal standard exists for their processing, harvesting, or packaging. Supplements do not have to be manufactured according to any quality control guidelines and ingredients do not need to be standardized. Manufacturers could be buying herbs, without testing them to determine the potency of ingredients and do not need to ensure they are not contaminated. Since products can be marketed in a unrestricted regulatory environment, consumers must realize that this lack of standardization will lead to variation in purity and strength of ingredients used in different brands.
Lack of Scientific Data
Most available research on herbal supplements has been done in Europe, Asia, and India but there is a paucity of data that has been generated in the U.S. Scientific research on both vitamin/mineral and herbal supplements is needed, but is costly, and the government cannot do it alone. DSHEA has helped to establish an office on Dietary Supplements that is working with the newly established National Center on Complementary Alternative Medicine within the National Institutes of Health to conduct more test clinical trials to determine the efficacy, and biological action of botanicals and dietary supplements.
In the meantime, manufacturers rely on existing data available from other studies which often have limitations and cannot be considered as conclusive. Many studies are based on animal data rather than human clinical trials. Often industry claims are based on testimonials, case studies or small sample size rather randomized, controlled, double-blind clinical studies. The lack of standardization of herbal products makes it even more difficult to compare efficacy of claims between different brands.
Currently, industry has not attempted to spend the millions of dollars required to conduct clinical trials as is done by pharmaceutical companies since supplements can be brought to market without it (as long as treatment for disease claims are not made). Supplements contain naturally available ingredients that are not patented, and are not exclusive. This makes it less likely that industry will want to pay for conducting a clinical trial since other manufacturers can market a product containing the same ingredients.
