The Dietary Supplement Health and Education Act defines dietary supplements as a category of food. However, there is one exception: if a dietary supplement meets the definition of a drug, it is regulated as a drug.
The Dietary Supplement Health and Education Act defines dietary supplements as a category of food. However, there is one exception: if a dietary supplement meets the definition of a drug, it is regulated as a drug.
Food is a material that to be eaten to enjoy the taste, smell, chew and functions to give energy, build and maintain tissue and regulate metabolism. Food material is always processes at home or in food premises never in a pharmaceutical place. Food is something to share with family and enjoy ingesting. Fruits are sources of vitamins that found in a balanced biochemical form, drug hardly to be in a balanced biochemical form. so what is your conclusion?
Since dietary supplements are designed to improve health without other functions such as enjoyment, taste, smell, etc they should be classified as drugs. Unfortunately the supplement industry is strong enough that in many places they have succeeded in obtaining laws which classify them as food. Or even worse they have obtained laws which classify them as neither so they escape any type of regulation or oversight. this results in their ability to make false claims and not deliver on promises.
Food invites a visceral experience through our senses. It is used as a way to nurture ourselves and others, we connect with others, celebrate social and cultural events and express ourselves as individuals and members of cultural contexts. Food has been experiences as gastronomic events long before modern western science began to reduce food into its individual chemical components.more recent managerialist regulation of ideas and concepts to protect either industry or the public casts a different perspective over something that is a basic human right.
While food has therapeutic value (comfort eating perhaps?) using particular nutrients to address a deficiency or condition is increasingly common in times of heightened risk management.
Using a legal definition as your starting point silences a much longer history of food. To subsequently take one position over the other will ultimately depend on how you want to position your work in a particular field. However it should not mean that you neglect/ignore other positionings.
The Dietary Supplement Health and Education act of 1994 classifies dietary supplements as a food but not a conventional food. They are to be taken as a supplement the regular diet to support the structure and function of the body as a whole or specific organ systems. They can contain vitamins, minerals, herbs, amino acids and any combination thereof. So in the United States dietary supplements are not regulated as drugs but neither are they regulated as conventional foods. They are supplements to the diet.
After conducting research on dietary supplements over the past 40 years, I’d like to pass on a few thoughts. I suspect the drafters of DSHEA would say dietary supplements are dietary supplements—that is why the law was crafted. I have found the FDA’s definitions very helpful in defining the difference between drugs and supplements—drugs are designed to prevent, treat, mitigate and cure disease. If the supplement makes these claims, the FDA will evaluate the need for an IND (Investigation for a New Drug). DSHEA encourages dietary supplement companies to focus on supplements that can enhance “structure and function” not cure diseases. I think there is a place for supplements that can add to the value of food. One exception is calcium supplementation for which the FDA allows a claim about preventing osteoporosis.
Don’t be discouraged by Joyce Morris dogmatic and anti-supplement stance. She is right in some cases but there are honorable companies manufacturing supplements. Additionally, since she is in a government agency, don’t let her rather strong negative generalizations discourage you from simply calling the FTC or FDA with you questions. I have found government agencies very helpful and evidence-oriented and rarely dogmatic.
Gilbert Kaats, I am not anti-supplement but I am pro safe and effective. You have no idea if the company is honorable or if you are getting what the label states since there is no regulation or oversight. My government employment does not inform my stand on this issue since this is not related to the area in which I have worked. It stems from being a good consumer and an advocate for informed consumers; the supplement industry fails me. Frankly if I was one of those honorable companies I would welcome regulation since it would prove that I produce a safe and effective product. Unfortunately they have fought such regulation so I have no way of knowing if their product delivers what they say it does.
The FDA defines a dietary supplement (DS) as "A dietary supplement is a product intended for ingestion that contains a "dietary ingredient" intended to add further nutritional value to (supplement) the diet. A "dietary ingredient" may be one, or any combination, of the following substances: a vitamin. a mineral. an herb or other botanical".Jun 8, 2015
A DS could either be a food or a drug. However classification affects its regulation. Many DS are classified as food so that manufacturers could register them in countries easily without having to prove any health benefit or side effect. This allows many DS easy entry into countries and after registration the products can then be touted as a miracle cure or energy boost etc.
Had they been registered as a drug then strict guidelines would then have to be followed and many DS would not be registered.
There are problems associated with food DS as there are no way to know that the contents are exactly as defined on the label. Safety for consumers become an issue.