FREQUENTLY ASKED QUESTIONS

Q. What does GMP mean?

A. Good Manufacturing Practice: The current Good Manufacturing Practice (GMP) requirements set forth in the Quality System (QS) regulation are promulgated under section 520 of the Food, Drug and Cosmetic (FD&C) Act. They require that domestic or foreign manufacturers have a quality system for the design, manufacture, packaging, labeling, storage, installation, and servicing of finished medical devices intended for commercial distribution in the United States. The regulation requires that various specifications and controls be established for devices; that devices be designed under a quality system to meet these specifications; that devices be manufactured under a quality system; that finished devices meet these specifications; that devices be correctly installed, checked and serviced; that quality data be analyzed to identify and correct quality problems; and that complaints be processed. Thus, the QS regulation helps assure that medical devices are safe and effective for their intended use. The Food and Drug Administration (FDA) monitors device problem data and inspects the operations and records of device developers and manufacturers to determine compliance with the GMP requirements in the QS regulation.

Q. What is a dietary supplement?

A. In the United States, a dietary supplement is defined under the Dietary Supplement Health and Education Act of 1994 (DSHEA) as a product that is intended to supplement the diet and bears or contains one or more of the following dietary ingredients: a vitamin, a mineral, an amino acid, a herb or other botanical (excluding tobacco), a dietary substance for use by people to supplement the diet by increasing the total dietary intake, or a concentrate, metabolite, constituent, extract, or combination of any of the above. Furthermore, it must be intended for ingestion in pill, capsule, tablet, powder or liquid form, not represented for use as a conventional food or as the sole item of a meal or diet and labeled as a "dietary supplement". Pursuant to the DSHEA, the Food and Drug Administration regulates dietary supplements as foods, and not as drugs.

Q. Is taking vitamins and minerals in quantities greater than the Recommended Dietary Allowance (RDA) unsafe?

A. No. Most vitamins and some minerals are safe at levels many times greater than the RDA. The RDA is the level of intake recommended to maintain health, and is not in any way a safety limit. In fact, for many nutrients, for example vitamins D and E, scientific research suggests potential benefits can be gained by intakes beyond the RDA. The same experts that establish the RDA also set Upper Levels of Tolerable Intake (UL). The UL is also not a safety limit, but simply identifies a level of daily intake at which there is no known toxicity, and at which there is sufficient evidence of safety for the nutrient. The UL neither suggests that intakes above that level are unsafe, nor does it constitute a recommended intake. For some vitamins, like C and E, the UL is more than 10 times higher than the RDA. In some cases there is no UL as is the case for some B vitamins. This is because no study has ever identified an unsafe level, even when large amounts have been given.

Q. Is it true that recent clinical studies show that supplements don't work?

A. No. Science moves in a stepwise fashion, and the steps are not always in a forward direction. Each new study adds to our total knowledge, even though it may sometimes seem that the results go back and forth, with positive news one week and negative news the next. What is important is the overall picture, and for dietary supplements the overall picture is pretty good. Calcium and vitamin D supplements help protect against osteoporosis, antioxidant supplements protect the eyes and the brain, omega-3 fatty acids are good for heart health, selenium may reduce the risk of getting prostate cancer, vitamin E and other vitamins reduce the risk of heart disease in some studies but not others and folic acid (a B vitamin) even helps protect against birth defects such as spina bifida. Perhaps the strongest testimony to the fact that supplements work is the fact that the National Institutes of Health and other research organizations are pouring millions of dollars into more studies using various supplements for health promotion and disease prevention. The results are good enough to justify that kind of investment, and they are good enough to provide a reason for people to add supplements to their healthy lifestyle choices.

Q. Are clinical trials are the most reliable tool for evaluating the benefits of specific nutrients or dietary habits?

A. Not necessarily. Clinical trials are a valuable and reliable tool for assessing the effectiveness of pharmaceutical products (drugs). The drug can be given to one group of patients and not to another group, and the difference in response can be observed. The patients are not already being exposed to the drug from their diet or any other sources.  They are getting it in the study or they are not getting it at all. Studying nutrients, both in nutritional supplements and food, is different. People are likely already getting these nutrients from their regular diets, and if participating in a nutritional study should not be asked to eliminate these foods so it becomes very difficult to evaluate the effects of the added amounts. Additionally, the benefits of specific nutrients or dietary patterns are related to disease prevention, not disease treatment. Such benefits may take years to develop, much longer than most clinical trials. Finally, most clinical trials are conducted in people who already have a disease, or very high risk factors for the disease, so these trials are not really testing preventive effects, but are essentially testing treatment effects. When it comes to dietary patterns and nutrient intake, large observational studies should be strongly considered in identifying those factors that make people healthy. For example, everything we know about the benefits of diets high in fruits and vegetables is based on observing what people ordinarily eat and analyzing the health benefits of certain patterns of intake. It is not based on clinical trials showing those benefits. The same may apply to long term supplement use. If an observational study in tens of thousands of nurses shows that women who take vitamin E for at least 2 years have a 40% lower risk of heart disease, that is good information, even if it does not come from a controlled clinical trial. When it comes to diet and nutrition, the best advice may be: Do what healthy people do.

Q. How do you select your Raw materials?

A. We take pride in our exceptionally high standards for raw material selection, employing an exhaustive process that meets or exceeds accepted purity standards. Only ingredients backed by adequate scientific research are included in our products; every nutrient is well researched for its metabolic pathways and potential side effects. Sports nutrition Labs understands the importance of purity and the need to address chemical sensitivities. Thus, we have established the following unmatched raw materials commitment:

Sports nutrition Labs nutritional supplements are hypoallergenic and 100% gluten-free Sports nutrition Labs products are free of all forms of soy protein.

Sports nutrition Labs never adds artificial sweeteners or detrimental levels of nutritive sweeteners to our products (sucrose, glucose, or fructose, including concentrated fruit juices)

Once we've designed a product with the right ingredients, our quest for excellence continues. Our nutrition and product development experts follow the latest research to ensure that we are using the finest ingredients available. Though not common industry practice, Sports nutrition Labs is always willing to switch to better ingredients when they become available. Why do we follow this practice, when our customers would likely not realize the difference? Simply, because a great deal of time and intellectual capital is invested in the development of Sports nutrition Labs formulas...and we believe in using only top quality ingredients for maximum efficacy.

Q. What other steps do you take to make sure you have a quality product?

A.  Nutrient form and synergistic formulations. Nutrient form selection is aimed at maximizing stability, absorption, and metabolic potential of individual nutrients or combinations of nutrients. Nutrient distribution is optimized through a variety of forms including capsules, tablets, softgels, powders, topicals, bars, and liquids. In many cases, our products are available in a variety of forms, because we recognize that different health conditions and personal tastes necessitate these options.

Synergies exist for many combinations of nutrients, and our formulas take full advantage of this principle. Sports nutrition Labs offers numerous formulas containing synergistic groups of nutrients that satisfy the therapeutic goals for various deficiency states and conditions.

Developing these exclusive formulas requires unique expertise and care. Our development experts employ a holistic approach, always taking into account the complexity of human metabolic pathways. When formulating a complex array of nutrients, we always review the complete clinical picture to avoid, for example, metabolic imbalances caused by high doses of one particular nutrient.

In addition to their inherent benefits, combination (synergistic) formulas often enhance compliance by minimizing the number of supplements a patient is asked to consume. These synergistic formulas cannot be found in stores.