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This page is a personal opinion on the status of U.S. regulation at the time at writing. It is more than ever vital to seek the latest regulatory advice before acting in this areana

Foods, that do you good

In recent years we have seen a boom in the area of "things that you can eat that will do you good", or to be more exact, things that are claimed "may" do you good. While neither a drug nor a conventional food, there are a whole range of "dietary supplements" that may be taken in the belief that they complement the normal intake of conventional food and in some way improve "well-being". The largest market for such products is clearly the USA, however entry into this market needs to be carefully planned.

Regulation of Dietary Supplements differs markedly from other areas of the Health Care industry, not least because as a comparatively new field written regulations have not always been produced and case law frequently determines the FDA enforcement approach.

Medical Foods

These are intended for dietary mangement, under the direction of a physician, where specific requirements have been established for a diagnosed condition. These foods may be administed orally or otherwise (for example: by tube or catheter). Such medical foods must not make drug claims (that is to prevent, mitigate or treat a condition) but can make claims about helping to meet the special dietary needs of a patient arising from a condition.

Conventional Foods

The essential characteristics of conventional foods are taste, aroma and nutrition. When one or more of these is missing, as it is in a capsule, then although a food, it is no longer a conventional food - by default we have defined a dietary supplement (something that supplements a diet of conventional food).

Dietary Supplements

Typically a dietary supplement is a concentration of one or more ingredients, found in conventional foods. It can be marketed in other forms, but must be labeled as a dietary supplement and not a conventional food. Premarketing clearance is not required from FDA if all the ingredients had been marketed in the USA prior to 15 October 1994.

Functional Foods

This has been the boom area over the last few years, but has no formal definition of regulatory framework. My working definition is that a functional food is a combination of conventional food and dietary supplement, such that one or more ingredients of the conventional food is boosted in concentration and/or other health-promoting ingredients, not generally found in the conventional food, are added. Given that a "Functional Food" does not have a regulatory status, FDA is rightly concerned about the safety of a conventional food with a "novel" added ingredient, yet CFSAN has a priority to ensure adding of dietary supplement ingredients to conventional foods is legal.

Classification

CFSAN (The Center for Food Safety and Applied Nutrition) has a 2001 priority to define the boundaries, but in the meantime it might help to speculate on an example:
You have a conventional food, a nutritious, good-tasting, good-smelling cereal bar. In order to attract the keep-fit market you wish to re-brand the product and market it on its high vitamin and mineral content.
Is it a conventional food or a dietary supplement?
What if you increase the vitamin and mineral content?
What if you increase the content significantly?
What if one of the ingredients does not normally occur in the conventional food?
What if that ingredient was not marketed in the U.S. until 1995?
What if the content is concentrated into a capsule?
... and how could your decision at each stage be affected by the marketing claims?

Claims

FDA accepts that conventional and functional foods can make the same bredth of claim as a dietary supplement, so long as it is through nutrional propieties and is not a drug claim (prevent, diagnose, treat a disease):

  1. related to a disease associate with nutional defficiency
  2. cite a documented effect of the nutrient
  3. describe a general "well-being" effect known to be associated with the nutrient
  4. related to the nutritional effect on thestructure or function of a human body

The 1994 Dietary Supplement Health and Education Act (DSHEA) limits the claims than can be made for a dietary supplement.

GMP

Although an Advanced Notice of Proposed Rulemaking (ANPR) was issued some years ago, no Dietary Supplement GMP's have yet been issued. 21CFR110 applies, but falls short of the full GMP's concentrating on sanitation of the equipment and environment. The industry body, the Council for Responsible Nutrition (CRN), drew up some recommendations which formed the basis of the ANPR, consequently a prudent manufacturer would assume that the Food GMP's apply and expect them to be extended in the near future to cover the following areas:

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Uploaded March 20, 2005
Last updated March 20, 2005
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