FDA Regulations Regarding Vitamins and Dietary Supplements
Dietary supplements, nutritional supplements or food supplement are preparations that supplement the diet and provides certain essential nutrients such as minerals, vitamins, fatty acids, fibers and amino acids that is either missing in the diet or is available but insufficient in quantities. The definition of dietary supplement varies from countries, with others categorizing it as food while others categorize it as natural health products or drugs. Codex Alimentarius; a collection of international guidelines ,standards ,codes and recommendations that relate to food production, food safety and foods categorize supplements containing dietary minerals and vitamins as food(Altman, pgs 34). The codex alimentarius that is an organization sponsored by food and Agriculture Commission and the world heath organization draws up these texts. This research paper gives an insight on the roles of Food and Drugs Administration and answers the question whether the FDA require more regulations to ensure the safety of Dietary supplements.
The FDA, which is an abbreviation for Food and Drug Administration, is responsible for the regulation of dietary supplements categorized as foods and not dietary supplements categorized as drugs. It is important to note the pharmaceuticals companies should obtain approval by the FDA, a process that involve assessing the benefits and the potential risks a head of their entry into the market. The distributors and manufacturers must notify the FDA before introducing before marketing the dietary supplements that contains new ingredients such as mineral, vitamins, amino acids herb or any other botanical( Flynn ,pgs 56).
The dietary supplement with new ingredients intended for use by people for the purposes of increasing the dietary intake of particular minerals, vitamins or the introduction of new ingredients to the supplements with an aim of increasing an extract, constituent, metabolite or concentrate or any combination from the above should not enter the market before notification of the FDA. Such a notification by distributors and manufacturers dealing in the food should indicate the information on safety of the new ingredient, pending the marketing of the dietary supplement until the seventy-five days after notification elapses. The FDA is responsible for reviewing the information to ascertain the adequacy of information provided and consider safety concerns (Altman, pgs 34).
In the year 2007, the FDA implemented the existing good manufacturing practices guidelines with an aim of ensuring that the quality of dietary supplements is up to the international standards ,is free of impurities or contaminant and the labeling is accurate. This policy equally ensures that the labeling, manufacturing, packaging and storing of the dietary supplements is up to standards set by FAO and WHO. The Food and Drugs Administration also monitors the design and the construction of the plants that manufacture the dietary supplements, the keeping of records, testing of ingredients ,final products and complaints processes as part of as part of quality assurance .
Good manufacturing practices refers to the strict and detailed procedures set out to ensure quality of the manufacturing process of certain products such as food, drugs and dietary supplements . The good manufacturing practices proposed by the Food and Drugs Administration (FDA) helps establish systems that are able to prevent inconsistency, product contamination, unsanitary manufacturing, mistakes in product labeling and other production processes that have effects on human health. In the year 2003, the Food and Drugs Administration proposed a guideline for the current good manufacturing practices in relations to manufacturing, dietary ingredients, packaging and the dietary supplements.
The Food and Drugs Administration experience certain challenges such as the 1994 passing of the Dietary Supplement Health and Education Act (DHSEA) , which limited the ability of the Food and drugs Administration to exercise authority over the dietary supplements as long as the distributors and manufacturers make no claim that their products treats ,prevents or cures diseases (Jaroff, pgs 75). The DHSEA is a product of intense lobbying by the manufacturers of the dietary supplements. This law exposes the consumers of dietary supplements to the risks of using substandard products, products containing harmful substances and the health risks associated with consumption of products with impurities and contaminants.
This had negative effect on the responsibility of Food and Drugs and Administration since it has to prove that a dietary supplement contains harmful substances or is not safe. As a result, the FDA has made very little progress in terms of ensuring that the manufacturing companies produce high quality and standardized products since it has only been able to top find the dietary supplement ephedra (the energy and weight loss substance) unsafe. The DHSEA provisions have negative impact on the regulation of the dietary supplement industry since it gives too much freedom to the dietary supplement manufacturers while restricting the ability of FDA to enforce standards and monitor quality of products.
DHSEA restricts the ability of Food and Drugs Administration to regulate the activities of manufacturers hence providing little protection to the consumers from using harmful products available in the market. It is important to note that under the Dietary Supplement Health and Education Act it is the responsibility of the manufacturers to ensure that the dietary supplement they are producing are actually safe for human consumption before they commence marketing the products or distributing the dietary supplement to the market. The Food and Drugs Administration on the other hand can only take appropriate action once the dietary supplements already reach the market. In general, the manufacturers of the dietary supplement do not have to get approval from the Food and Drugs Administration of register with the FDA before they produce or sell the dietary supplements to the public. It is therefore incumbent upon the manufacturers of the dietary supplements to ensure that their products are safe for human consumption.
There is equally need to develop regulations that compel the manufacturers of dietary supplements to convince or demonstrate to the Food and Drugs Administration that their products are safe for human consumption and that the information provided on the label is accurate. Currently, there is no provision or regulation in the law that compels the manufacturers of the dietary supplements to demonstrate to the Food and Drugs Administration or the consumers that the information and evidence on the safety of their products is accurate. It should be mandatory requirement of every manufacturer to inform the FDA and by extension, the consumers of the evidence on the safety of dietary supplements they are producing.
The FDA need to have extra regulations to enable it validate claims from consumers that regards the safety of dietary supplements. The FDA Should be able the claims that concerns on the contents of advertisements, printed media, product labels and media. Currently, the responsibility of validating such claims from the consumers or public lies with the manufacturers. The Food and Drugs Administration should be able to handle the claims relating to health, structures or function and the ingredient content claims. The is need to establish legislations that mandates the FDA consumer claims concerning disease, food substance or health ,the contents of the dietary supplements, and the potential benefits of using a particular dietary product. The FDA should have a greater influence and a tighter control of the dietary supplement industry in order to protect the consumers from unsafe products.
There is need to come up with a regulation that eliminates the restrictions on health claims concerning dietary supplements since there are sufficient mechanisms that can hinder misleading and false claims. This will enable the FDA ensure that weight loss claims are true .It is equally prudent to come up with regulations that will enable the FDA keep information on the dietary supplements in the market and their manufacturers for purposes of handling claims and concerns from the consumers. The regulations should enable the FDA have other means of carrying out their mandate other than relying on adverse reports such as deaths, illnesses and injuries.
There debate on whether the Food and Drugs Administration require extra regulations to perform its duties is double sided. The argument that the Food and Drugs Administration has adequate regulations to carry out its limited mandated advances that the manufacturers of dietary supplements should not register with the Food and Drugs Administration and that the manufacturers do not need to obtain any kind of approval from the FDA before the produce or sell their products to the consumers. The are people who are comfortable with the fact that the manufacturers are and should be responsible for ensuring safety of the dietary supplements before releasing their products to the market.
The passing of DSHEA thrived on the argument that consumers should have an opportunity to make their own choices as regards the use or consumption of dietary supplement and that involvement of the FDA amounts to government infringing on the rights of Americans to choose. In line with this argument is the claim that consumers should be able to make choices on preventive healthcare programs depending on data from studies on health benefits of particular dietary supplements as long as the study is scientific. The individuals who favor this argument hold that the American government should not impose regulations that are unreasonable hence slowing or limiting the flow of information and safe dietary supplements from reaching the consumers.
There is an argument that if unrestricted or unlimited, the FDA will arbitrarily take punitive actions against particular dietary supplement manufacturers without fully demonstrating that their dietary supplements are actually unsafe. The power of FDA to remove a product from the market need to be restricted since they may remove a dietary supplement from the market based on some kind of arbitrary standard they consider reasonable and based on lack of adequate information.
In conclusion, the FDA needs to have more regulations to ensure that they execute their mandate properly and protect the consumers from any unsafe dietary supplements. The manufacturing companies should be able to demonstrate to the FDA that the dietary supplements they are producing are safe, as this will eliminate the chances of any unsafe product from reaching the market. The current regulations and legislations in place are not sufficient to enable the FDA protect the consumers from the risks of using harmful substances marketed as food supplement. There is need to come up with policies that can enable the Food and Drugs Administration ensure that the manufacturers of dietary supplements operate within the internationally recognized standards.
The regulations should help the Food and Drugs Administration ensure safety of the dietary supplements before they enter the market. It is however important to ensure that any regulation aimed at bolstering the efficiency of the FDA does not affect the manufacturers of dietary supplement negatively hence resulting in a deficit of the important products. The FDA should be able to ensure that the dietary supplements are safe for consumption and that the consumers are in a position to make informed choices about the dietary supplements in order to improve their health.