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How Can a Company Build a Dossier of Credible
Scientific Information about Its Product? How Can a Company Build a Dossier of Credible Scientific Information about Its Product? The first step is analytical testing, using recognized methods such as High Performance Liquid Chromatography (HPLC) to determine the components of the product and to define the product specifications. Each batch should be backed by a Certificate of Analysis showing measurement of: Marker compounds, if known and if
claims are made about them; The next step is to establish safety of the product through toxicology testing. This includes acute, subacute, subacute-chronic and chronic toxicology studies performed by laboratories that adhere to Good Laboratory Practices (GLPs). AIBMR has years of experience in this area. Once the product specifications are defined, batch-to-batch consistency is documented and safety is established, the final components are clinical efficacy studies. This can include in vitro bioassays and animal studies, leading to human trials. Small, uncontrolled pilot trials are a start in this process; the "gold standard" is the double-blind, randomized, placebo-controlled trial with a sufficient number of subjects to ensure statistical power. Such studies should always conform to Good Clinical Practices (GCP) guidelines. Various pharmacokinetic studies are also important, to determine how the product is absorbed, metabolized and excreted, and might interact with other agents. Once can never do enough nonclinical and clinical studies on an ingredient or product. Dietary supplements and natural products offer many benefits, but claims for these benefits must be substantiated by sound science - Federal and State regulators, legislators, the health care community and the public are demanding no less. Claims must be evidenced based. The FDA, echoing guidance given by the President's Commission on Dietary Supplement Labels in its 1997 report, as well as the Federal Trade Commission's (FTC) standard for substantiation, has stated that dietary supplement claims should be substantiated by "competent and reliable scientific evidence." There is simply no substitute for properly designed clinical trials in building a credible dossier of scientific evidence that will hold up under scrutiny. Companies that invest in clinical trials will be the survivors and the winners in the dietary supplement market over the long haul. The acronym "GRAS" stands for "Generally Regarded As Safe." From a regulatory standpoint, GRAS applies to ingredients in food products. GRAS status is not conferred by the FDA, nor does one "petition" FDA to grant GRAS status. The FDA's proposed new regulation, issued in 1997, creates a notification procedure whereby any person may notify FDA of its determination that a particular use of a substance is GRAS, based on knowledge of safety that is generally recognized by qualified experts. For a substance to be recognized as "safe" requires reasonable certainty in the minds of competent scientists that the substance is not harmful under its intended use. The notification must include detailed information about this recognition of safety by experts in the field. FDA reviews the notification but does not "approve" the substance as safe. Under the law, manufacturers of food products are responsible for ensuring product safety. It is illegal to sell an unsafe food or dietary supplement product. An expert panel consists of qualified scientists who are knowledgeable in a particular field of study, for example the safety of substances added to foods, as in the case of GRAS determination. How can some companies do clinical trials so inexpensively and is this a sound business decision? Poorly done clinical trials do not provide credible scientific evidence for claim substantiation and are unlikely to qualify for publication in peer-reviewed scientific journals. The requirements for a sound clinical trial include protocol design by experts in the subject of the trial, earlier involvement by a biostatistician expert in performing a power analysis, approval of the protocol by an Institutional Review Board (IRB), recruitment of appropriate subjects that fit the criteria for inclusion, statistical analysis of the data by a competent biostatistician and sound interpretation of the outcome data by knowledgeable scientists. It may cost more, but this forward-thinking investment provides a sound business strategy when the trial stands up under the rigors of peer-review. Bargain basement clinical trials can be a waste of precious time, human resources and research dollars. The results of many "clinical trials" don't get past being presented at scientific meetings. What are New Dietary Ingredients? Any substance that was not in the food supply as a dietary supplement ingredient prior to passage of DSHEA in October of 1994 is a New Dietary Ingredient or "NDI." A manufacturer intending to market a New Dietary Ingredient must submit to FDA documented evidence establishing that the NDI is reasonably expected to be safe as used in the dietary supplement. This is done via a NDI Notification. This submission must be made at least 75 days before introduction of the product into commerce. Ingredients in commerce prior to October 1994 are presumed safe and thus "grandfathered" under DSHEA. In either case, the manufacturer bears full responsibility for product safety. FDA does not "approve" any dietary supplement or supplement ingredient as safe. It is very important to know that if the agent in question is "chemically altered" and is significantly different for this reason from the grandfathered ingredient to such an extent that it no longer resembles the ratio and profile of components found in the grandfathered product or as it may be found in nature (given wide ranges for variance due to growing conditions) it is not protected as such and is a "new" ingredient. It will need to be submitted to the FDA. |
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