Q: How are nutritional supplements regulated?
The Dietary Supplement Health and Education Act (DSHEA), which passed in 1994 completely describes the regulation rules and process. In summary: Under DSHEA, the company is responsible for determining that the dietary supplements it manufactures or distributes are safe and that any representations or claims made about the product are substantiated by adequate evidence to show they are not false or misleading.
Under DSHEA, once the product is marketed, the Food & Drug Administration (FDA) has the responsibility for showing that a dietary supplement (DS) is "unsafe," before it can take action to restrict the product's use or removal from the marketplace. However, manufacturers and distributors of DS must record, investigate and forward to FDA any reports they receive of serious adverse events associated with the use of their products that are reported to them directly. FDA is able to evaluate these reports and others to identify early signs that a product may pose safety risks.
As of 2011 all DS manufacturers must follow Current Good Manufacturing Practices (cGMPs), which means testing is required for all raw materials and finished products. These new regulations focus on practices that ensure the identity, purity, quality, strength and composition of dietary supplements. If you are worried about safety, here is some comforting information: The Townsend Letter, April 2010 reported that according to the most recent information collected by the US National Poison Data System, (174 page annual report of the American Association of Poison Control Centers, published in the journal Clinical Toxicology), there was not even one death cause by a dietary supplement. Additionally, there were zero deaths from multiple or B vitamins, zero deaths from vitamins A, C, D or E , zero deaths from minerals, and zero deaths from any other vitamin or herbal products. No man, woman or child died from nutritional supplements. Compare this to a report published in JAMA that said that an estimated 2,216,000 (1,721,000 to 2,711,000) hospitalized patients had serious adverse drug reactions (ADRs) and 106,000 (76,000 to 137,000) had fatal ADRs, making these reactions between the fourth and sixth leading cause of death. And just to clarify, these were patients that received the correct doses of the correct drugs administered by the proper health care professional that still had so many ADR's that it is a leading cause of DEATH!
Q: Why are nutritional supplements regulated by the FDA?
Before 1994 dietary supplements were subject to the same regulatory requirements as were foods by the FDA. That changed when Congress defined the term "dietary supplement" in the Dietary Supplement Health and Education Act (DSHEA) of 1994.
A dietary supplement is a product taken by mouth that contains a "dietary ingredient" intended to supplement the diet. Whatever their form may be, DSHEA places dietary supplements (DS) in a special category under the general umbrella of "foods," and therefore the FDA still has the responsibility to help regulate the industry albeit a lesser role.
The FDA (Center for Food Safety and Applied Nutrition) and the Federal Trade Commission (FTC) are both involved.
As of 2011 all dietary supplement manufacturers must follow Current Good Manufacturing Practices (cGMPs), which means testing is required for all raw materials and finished products. Supplements are often now marketed without proving they work as claimed making the FDA or FTC catch up with them after they have been distributed. If there are frequent reports of adverse reactions the FDA will investigate and if they find fault with product, they have the power to pull it from the market, levy fines, etc. The FTC cracks down on false claims and can also remove the product and/or fine the company at fault.
Q: How are dotFIT supplements manufactured?
In short, dotFIT products go above and beyond the minimum requirements - they are manufactured to meet or exceed all current requirements under the DSHEA, and then they are sent to a 3rd-party to independently test and confirm. It's an extra step that ensures purity, potency, safety and nutrient delivery.
These 3rd-party entities (e.g. NSF Certified for Sport or NPA, Natural Products Association) monitor/verify practices such as: yearly audits, facility cGMPs compliance, standard operating procedures (SOPs) require that all active and inactive ingredients and components for each batch of product are tested from raw material to finished product for conformance to specifications. Tests include confirmation of identity, potency, and purity. Another extra step in the SOPs also stipulate that finished products are tested for purity prior to release. Furthermore, key marker ingredients are tested to confirm that finished product meets label claims. All tests are performed by qualified operators using valid analytical methods on calibrated instruments.
Tested, tested, and tested again.
Keep in mind that dotFIT uses an FDA-registered pharmaceutical manufacturer. This means that the manufacturer holds a state FDA-registered pharmaceutical certificate and thus must sell OTC’s (over the counter) type products (which they do), which are held to more stringent standards than dietary supplement manufacturers.
The means that the dotFIT products benefit from all of the additional quality control practices. It is just one more weapon in your arsenal to protect the consumer with purity, potency, testing of all products (heavy metals) and so on…..
But wait - there's more!
Formulation Pre-Development Criteria. Before dotFIT nutritional compounds become products or are recommended for consumer use, all ingredients must survive rigorous legal and scientific review and testing. The following conditions are met:
- Identify best, current clinical research supporting use of active ingredients (evidence-based)
- Identify data supporting safety and efficacy including long-term empirical data (see Table 1 below and Evaluation Guidelines)
- Identify proper ingredient dosage and forms matched to positive outcomes from clinical data
- As science progresses, all products must be updated immediately
- Products are designed in appropriate delivery forms established by each product’s ingredients, desired target tissues, and the amounts required in specific time periods to deliver on the product claims. In other words, validate that the right ingredients and amounts get to the right places at the right times.
- Customized finished products are tested in a simulated human digestive system to validate whether release patterns match their respective designed criteria in order to assure the desired results
- Dietary supplement products and powders are manufactured in a FDA-registered pharmaceutical facility, in compliance with Good Manufacturing Practices (GMP)
- Ingredient testing for purity, potency and delivery from raw materials to finished product
- Final product rigorous testing, both in-house and through third-party, FDA-approved and NSF-certified laboratories, assures users that all nutritional claims meet or surpass FDA guidelines, USDA guidelines, and industry norms
- All formulas must be able to work in synergy with other dotFIT products in order to avoid nutrient overages, which are common with typical, indiscriminate supplement use dotFIT programs consider diet, medications, and other dotFIT products before a personalized dietary supplement recommendation is generated. This assures the user remains in a safe and optimal nutrient range throughout the day.
dotFIT foods cannot be “spiked” with unnecessary nutrients. Most other products in this space (e.g. bars, shakes, ready-to-drinks, etc.) are heavily spiked with many nutrients that can lead to undesirable levels within the body when combining multiple manufacturers, products and normal food intake. When consuming only dotFIT products, as directed with one’s normal daily food intake, the recipient can be assured of keeping the body at a safe and optimal nutrient level.
dotFIT must provide complete customer product/program education and support, including full disclosure regarding product ingredients, safety and manufacturing.
Product Testing Documentation
- Tests that include disintegration, dissolution, stability, purity (no contaminants) and potency, which includes the finished product’s certificate of analysis
- In-house and 3rd party product validation and testing methods based on all available certified protocols including applicable USPs (United States Pharmacopeia, an official compendia of standards) and other international compendia – also see dotFIT Product Manufacturing and Testing document in Appendix at www.dotfit.com/SRG
- Appropriate peer-review research that supports the dosage and purpose of the compound
- Proof of equivalence or evidence that a given dose of a product must contain a certain amount of key ingredients in order to produce a known effect
- Proof that products will be absorbed and utilized by the body
- Assurance that the substance is nontoxic, along with list of any known potential side effects and drug interactions
- Qualified personnel and support documents available to all consumers via www.dotFIT.com or 877.436.8348