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Chemical Muscle Enhancement (The BDR) By Author L. ReaTABLE OF CONTENTS'S WARNING: REA.
Table of contents

We understand and expect that some individuals may not agree with our interpretations of the literature or what category we have assigned a particular supplement, but it is important to appreciate that some classifications may change over time as more research becomes available. An ergogenic aid is any training technique, mechanical device, nutritional ingredient or practice, pharmacological method, or psychological technique that can improve exercise performance capacity or enhance training adaptations [ 2 — 4 ].

Ergogenic aids may help prepare an individual to exercise, improve exercise efficiency, enhance recovery from exercise, or assist in injury prevention during intense training. Although this definition seems rather straightforward, there is considerable debate regarding the ergogenic value of various nutritional supplements.

A consensus exists to suggest that a nutritional supplement is ergogenic if peer-reviewed studies demonstrate the supplement significantly enhances exercise performance following weeks to months of ingestion e.

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On the other hand, a supplement may also have ergogenic value if it acutely enhances the ability of an athlete to perform an exercise task or enhances recovery from a single exercise bout. The ISSN has adopted a broader view regarding the ergogenic value of supplements. Herein, we have adopted the view that a supplement is clearly ergogenic if most of human studies support the ingredient as being effective in promoting further increases in muscle hypertrophy or performance with exercise training. Conversely, supplements that fall short of this standard and are only supported by preclinical data e.

Further, dietary ingredients may also include extracts, metabolites, or concentrates of those substances. Dietary supplements may be found in many forms such as tablets, capsules, softgels, gelcaps, liquids, or powders, but may only be intended for oral ingestion. Dietary supplements cannot be marketed or promoted for sublingual, intranasal, transdermal, injected, or in any other route of administration except oral ingestion.

A supplement can be in other forms, such as a bar, as long as the information on its label does not represent the product as a conventional food or a sole item of a meal or diet. The law ensures the authority of the FDA to provide legitimate protections for the public health.

The Federal Trade Commission FTC also continues to have jurisdiction over the marketing claims that dietary supplement manufacturers or companies make about their products. In this respect, the extent to which information is shared and jurisdiction between these two entities overlaps with regard to marketing and advertising dietary supplements continues to increase.

In the United States, dietary supplements are classified as food products, not drugs, and there is generally no mandate to register products with the FDA or obtain FDA approval before producing or selling supplements to consumers. The rationale for the U. This product is not intended to diagnose, treat, cure, or prevent any disease. Although many dietary ingredients have been introduced into dietary supplements since October and have not been submitted to the FDA for a safety review, nutritional supplementation writ large is generally safe.

Perhaps more alarming is a report by the Centers for Disease Control suggesting 2,, emergency room visits were due to prescription drug-related events which dwarfs the emergency room visits due to dietary supplements adjusted from 23, visits after excluding cases of older adults choking on pills, allergic reactions, unsupervised children consuming too many vitamins, and persons consuming ingredients not defined by DSHEA as a dietary supplement [ 5 ].

Notwithstanding, there have been case reports of liver and kidney toxicity potentially caused by supplements containing herbal extracts [ 7 ] as well as overdoses associated with pure caffeine anhydrous ingestion [ 8 ].

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Collectively, the aforementioned statistics and case reports demonstrate that while generally safe, as with food or prescription drug consumption, dietary supplement consumption can lead to adverse events in spite of DSHEA and current FDA regulations described below. Recognizing that new and untested dietary supplement products may pose unknown health issues, DSHEA distinguishes between products containing dietary ingredients that were already on the market and products containing new dietary ingredients that were not marketed prior to the enactment of the law.

The first criterion is silent as to how and by whom presence in the food supply as food articles without chemical alteration is to be established. The second criterion—applicable only to new dietary ingredients that have not been present in the food supply—requires manufacturers and distributors of the product to take certain actions. The guidance prompted great controversy, and FDA agreed to issue a revised draft guidance to address some of the issues raised by industry. The purpose of the Draft Guidance was to help manufacturers and distributors decide whether to submit a premarket safety notification to FDA, help prepare NDI notifications in a manner that allows FDA to review and respond more efficiently and quickly, and to improve the quality of NDI notifications.

The Draft Guidance has been criticized by industry and trade associations for its lack of clarity and other problems. Self-Affirmed GRAS is when a company has a team of scientific experts evaluate the safety of their ingredient. There is no requirement that the safety dossier be submitted to FDA but is used by the company as an internal document that may be relied upon if the ingredient is challenged by the FDA. In any event, the likelihood of another revised Draft Guidance from FDA becoming available in the future is high, and possibly more enforcement actions taken against companies that market an NDI without submitting a notification.

In response to growing criticism of the dietary supplement industry, the th Congress passed the first mandatory Adverse Event Reporting AER legislation for the dietary supplement industry. After much debate in Congress and input from the FDA, the American Medical Association AMA , many of the major supplement trade associations, and a host of others all agreed that the legislation was necessary and the final version was approved by all.

The law strengthens the regulatory structure for dietary supplements and builds greater consumer confidence, as consumers have a right to expect that if they report a serious adverse event to a dietary supplement marketer the FDA will be advised about it. An adverse event is any health-related event associated with the use of a dietary supplement that is adverse. A serious adverse event is an adverse event that A results in i death, ii a life-threatening experience, iii inpatient hospitalization, iv a persistent or significant disability or incapacity, or v a congenital anomaly or birth defect; or B requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described under subparagraph A.

Once it is determined that a serious adverse event has occurred, the manufacturer, packer, or distributor responsible person of a dietary supplement whose name appears on the label of the supplement shall submit to the Secretary of Health and Human Services any report received of the serious adverse event accompanied by a copy of the label on or within the retail packaging of the dietary supplement.

The responsible person has 15 business days to submit the report to FDA after being notified of the serious adverse event. Following the initial report, the responsible person must submit follow-up reports of new medical information that they receive for one-year. The FDA has various options to protect consumers from unsafe supplements. The FDA also has the authority to protect consumers from dietary supplements that do not present an imminent hazard to the public but do present certain risks of illness or injury to consumers.

The law prohibits introducing adulterated products into interstate commerce. The standard does not require proof that consumers have actually been harmed or even that a product will harm anyone. It was under this provision that the FDA concluded that dietary supplements containing ephedra, androstenedione, and DMAA presented an unreasonable risk.

Most recently, FDA imposed an importation ban on the botanical Mitragyna speciose, better known as Kratom. In , FDA issued Import Alert 54—15, which allows for detention without physical examination of dietary supplements and bulk dietary ingredients that are, or contain, Kratom. Criminal penalties are present for a conviction of introducing adulterated supplement products into interstate commerce.

While the harms associated with dietary supplements may pale in comparison to those linked to prescription drugs, recent pronouncements from the U.

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Department of Justice confirm that the supplement industry is being watched vigilantly to protect the health and safety of the American public. However, it was not until that the cGMPs were finally approved, and not until that the cGMPs applied across the industry, to large and small companies alike. The adherence to cGMPs has helped protect against contamination issues and should serve to improve consumer confidence in dietary supplements.

The market improved as companies became compliant with cGMPs, as these regulations imposed more stringent requirements such as Vendor Certification, Document Control Procedures, and Identity Testing. These compliance criteria addressed the problems that had damaged the reputation of the industry with a focus on quality control, record keeping, and documentation. However, it does appear that some within the industry continue to struggle with compliance.

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In Fiscal Year , it was reported that approximately Further, Undoubtedly, relying on certificates of analysis from the raw materials supplier without further testing, or failing to conduct identity testing of a finished product, can result in the creation of a product that contains something it should not contain such as synthetic chemicals or even pharmaceutical drugs. All members of the industry need to ensure compliance with cGMPs. According to the Nutrition Labeling and Education Act NLEA , the FDA can review and approve health claims claims describing the relationship between a food substance and a reduced risk of a disease or health-related condition for dietary ingredients and foods.

However, since the law was passed it has only approved a few claims. The delay in reviewing health claims of dietary supplement ingredients resulted in a lawsuit, Pearson v. Shalala , filed in After years of litigation, in the U. Court of Appeals for the District of Columbia Circuit ruled that qualified health claims may be made about dietary supplements with approval by FDA, as long as the statements are truthful and based on adequate science. Supplement or food companies wishing to make health claims or qualified health claims about supplements can submit research evidence to the FDA for review.

The FTC also regulates the supplement industry. Further, before marketing products, they must have evidence that their supplements are generally safe to meet all the requirements of DSHEA and FDA regulations. This has increased job opportunities for sports nutrition specialists as well as enhanced external funding opportunities for research groups interested in exercise and nutrition research. While the push for more research is due in part to greater scrutiny from the FDA and FTC, it is also in response to an increasingly competitive marketplace where established safety and efficacy attracts more consumer loyalty and helps ensure a longer lifespan for the product in commerce.

Companies that adhere to these ethical standards tend to prosper while those that do not will typically struggle to comply with FDA and FTC guidelines resulting in a loss of consumer confidence and an early demise for the product. A common question posed by athletes, parents, and professionals surrounding dietary supplements relates to how they are manufactured and perceived supplement quality.

In several cases, established companies who develop dietary supplements have research teams who scour the medical and scientific literature looking for potentially effective nutrients. These research teams often attend scientific meetings and review the latest patents, research abstracts presented at scientific meetings, and research publications. Leading companies invest in basic research on nutrients before developing their supplement formulations and often consult with leading researchers to discuss ideas about dietary supplements and their potential for commercialization.

Other companies wait until research has been presented in patents, research abstracts, or publications before developing nutritional formulations featuring the nutrient. Upon identification of new nutrients or potential formulations, the next step is to contact raw ingredient suppliers to see if the nutrient is available, if it is affordable, how much of it can be sourced and what is the available purity. Sometimes, companies develop and pursue patents involving new processing and purification processes because the nutrient has not yet been extracted in a pure form or is not available in large quantities.

Reputable raw material manufacturers conduct extensive tests to examine purity of their raw ingredients. When working on a new ingredient, companies often conduct series of toxicity studies on the new nutrient once a purified source has been identified. The company would then compile a safety dossier and communicate it to the FDA as a New Dietary Ingredient submission, with the hopes of it being allowed for lawful sale.

When a powdered formulation is designed, the list of ingredients and raw materials are typically sent to a flavoring house and packaging company to identify the best way to flavor and package the supplement. In the nutrition industry, several main flavoring houses and packaging companies exist who make many dietary supplements for supplement companies. Most reputable dietary supplement manufacturers submit their production facilities to inspection from the FDA and adhere to GMP, which represent industry standards for good manufacturing of dietary supplements.

Some companies also submit their products for independent testing by third-party companies to certify that their products meet label claims and that the product is free of various banned ingredients. For example, the certification service offered by NSF International includes product testing, GMP inspections, ongoing monitoring and use of the NSF Mark indicating products comply with inspection standards, and screening for contaminants. More recently, companies have subjected their products for testing by third party companies to inspect for banned or unwanted substances.

These types of tests help ensure that the dietary supplement made available to athletes do not contained substances banned by the International Olympic Committee or other athletic governing bodies e. While third-party testing does not guarantee that a supplement is void of banned substances, the likelihood is reduced e.

Moreover, consumers can request copies of results of these tests and each product that has gone through testing and earned certification can be researched online to help athletes, coaches and support staff understand which products should be considered. In many situations, companies who are not willing to provide copies of test results or certificates of analysis should be viewed with caution, particularly for individuals whose eligibility to participate might be compromised if a tainted product is consumed.

The ISSN recommends that potential consumers undertake a systematic process of evaluating the validity and scientific merit of claims made when assessing the ergogenic value of a dietary supplement [ 1 , 4 ]. This can be accomplished by examining the theoretical rationale behind the supplement and determining whether there is any well-controlled data showing the supplement is effective.

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Supplements based on sound scientific rationale with direct, supportive research showing effectiveness may be worth trying or recommending. Sports nutrition specialists should be a resource to help their clients interpret the scientific and medical research that may impact their welfare and help them train more effectively.

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The following are recommended questions to ask when evaluating the potential ergogenic value of a supplement. Most supplements that have been marketed to improve health or exercise performance are based on theoretical applications derived from basic science or clinical research studies. Based on these preliminary studies, a dietary approach or supplement is often marketed to people proclaiming the benefits observed in these basic research studies.