The law provides FDA with appropriate regulatory authority and ample enforcement tools to protect consumers while still allowing them the desired access to a wide variety of affordable, high quality, safe and beneficial dietary supplement products. In passing this landmark legislation, Congress set forth a number of "findings" which emphasize the importance of communicating the positive benefits of supplements to the American public. Congress found that:. DSHEA specifically reaffirmed the status of dietary supplements as a category of food and created a specific definition for dietary supplements. DSHEA made it clear that ingredients of dietary supplements could not be regulated as food additives. These are considered safe for continued consumer use.
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This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Registered in England and Wales. Number Steve Myers Apr 09, So, for more than 50 years, supplements were regulated as foods. During this period, FDA was against this regulatory classification of dietary supplements, according to some supplement industry insiders. While FDA denied it was trying to restrict access to supplements, its enforcement actions started to raise eyebrows and concerns.
In the late s and early s, FDA raided and sued dietary supplement businesses. The agency's infamous raid of Dr. Jonathon Wright's naturopathic clinic was centered on use of banned tryptophan and was a final straw for the natural products industry. DSHEA established a definition for dietary supplements as "a product intended to supplement the diet.
However, a dietary supplement cannot be represented as a conventional food or intended to serve as an entire meal. Most importantly, DSHEA established dietary supplements and their ingredients are not subject to food additive regulations. Another major principle set forth by DSHEA was making FDA responsible for proving a dietary supplement is unsafe or illegal before taking regulatory action. Lest anyone think or claim this means FDA's hand are tied, DSHEA laid out numerous regulatory mandates to provide the agency with tools to regulate the supplement industry.
First and foremost, FDA can act on a supplement that poses "significant or unreasonable risk of illness or injury" when taken according to the labeled use recommendations or ordinary conditions of use. Also, before any new ingredient is marketed in a supplement, the company must first submit to FDA a safety-focused new dietary ingredient NDI notification.
DSHEA also established requirements for labeling, claims and manufacturing quality. As the industry stared down an uncertain future in the early s, the passage of DSHEA set a foundation for moving forward as an industry with its own set of regulations. The tug of war between the longstanding food categorization and the growing FDA desire to move supplements toward a drug-like regulatory model was supposed to be solved by DSHEA.
The act defined dietary supplements and laid out the framework for claims, labeling, quality manufacturing and bringing new products to market. The promise of DSHEA was for free consumer access to healthy dietary supplements that are manufactured to high-quality standards, labeled accurately and informatively, and able to communicate health benefits in a responsible and substantiated manner.
Additionally, the ever-tightening funding for FDA, and the agency's enforcement activity to weed out the outliers troubles the supplement industry. The act established many great foundations for industry, but its overall effect has been mixed due to slow implementation and enforcement, not to mention compliance with certain mandated requirements.
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Dietary Supplement Health and Education Act of 1994
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The Importance of DSHEA: Past, Present and Future
As the market continues to expand and evolve, so too must the laws that protect consumers from potential harm and misleading communication. This article is meant to begin a scientific dialogue on how regulations may be improved to provide both ease of access and safer products to the consumer by focusing on 4 topics: premarket approval, label claims, current Good Manufacturing Practices, and adverse event reporting. The DSHEA currently defines the term dietary supplement as a product that is intended to supplement the diet and may contain one or more dietary ingredients. A dietary ingredient may be any of the following: a vitamin or a mineral; an herb or other botanical; an amino acid; a dietary substance for use by humans to supplement the diet by increasing the total dietary intake; a concentrate, metabolite, constituent, extract, or combination of the preceding ingredients, and, that meet other criteria specified in Section ff 2 - 3 1. As a result of my previous employment as a senior scientist and regulatory expert for the dietary supplement industry's leading trade association, I felt that my perspective may help to begin a balanced dialogue on how the current law may be improved to provide continued ease of access and safer products to the consumer. The Food Safety Modernization Act of 3 and the Bioterrorism Act of 4 are 2 prominent examples of major pieces of conventional food legislation that are also applicable to dietary supplements.
U.S. Food and Drug Administration
This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Registered in England and Wales. Number Steve Myers Apr 09,