This special collection of papers in Analytical and Bioanalytical Chemistry includes contributions from industry, academia, and government related to the analytical challenges associated with the biological, analytical, and regulatory aspects of nutraceutical preparation and analysis.
Much of the current research focuses on high-resolution mass spectrometry approaches to material characterization and authentication as well as various aspects of quality control. This collection is an excellent representation of the current research effort in the area of functional foods and dietary supplements, and we hope you enjoy its contents.
These research areas have made great strides in recent years, but the constantly changing marketplace leaves many important questions unanswered. Google Scholar. Public Law — [H. FDA Current good manufacturing practice in manufacturing, packaging, labeling, or holding operations for dietary supplements. Docket no. Download references. You can also search for this author in PubMed Google Scholar.
Correspondence to Melissa M. Phillips and Catherine A. Thus, manufacturers and retailers have a range of legal and regulatory categories in which their products may be classified. This article describes the definitions provided in the FFDCA for a drug and a food, the safety and labeling requirements of various food categories, and types of possible claims for dietary supplements.
In marketing such products, manufacturers may come under one of several existing regulatory options. This article discusses the definitions of a drug and a food set forth by the FFDCA, which provides the regulatory authority and milieu for these products. The primary determinant, however, of the regulatory status of a food or a drug is its intended use, which is determined in large part by the label and the labeling information accompanying the product.
If a product is determined to be a food, it can be regulated as a food in conventional form includes foods for special dietary use , as a dietary supplement, as a medical food, or as an infant formula. With the absence of specific regulatory categories for functional foods, their regulation is accomplished through existing food and drug regulations. This subparagraph provides an exception for foods regarding claims about structure or function.
Through case law, foods have also been defined as substances that provide taste, aroma, or nutritive value 2. As discussed in the preamble of a recent final rule, foods can bear structure or function claims if the claim derives from their nutritive value 3.
However, if a claim describes a structure or function effect that is not related to nutritive value, the claim can be made only if the product meets requirements for marketing as a dietary supplement or as a drug. However, a claim that cranberry products help to maintain urinary tract health may be permissible on both cranberry products in conventional food form and dietary supplement form if it is truthful, not misleading, and derives from the nutritional value of cranberries.
The claim is not a health claim because no disease is mentioned explicitly or implicitly see section r 1 B of the FFDCA. Only if the claimed benefit did not derive from the nutritional value of cranberries would it be true that the claim could appear on a dietary supplement but not a conventional food.
Dietary supplement products provide the other exception for which a product would not be considered a drug if it made a structure or function claim on the label or in labeling. If the claim is to diagnose, cure, mitigate, treat, or prevent a disease, the product would be considered a drug. The FDA recognizes different categories of foods, one of which is foods in conventional food form, the most prevalent foods in the general food supply.
Within the conventional food category is a category called foods for special dietary use FSDU. The safety requirements for these products are the general food safety requirements. Another category of foods, defined in the Orphan Drug Amendments of 6 , are medical foods section 5 b 3 of the Orphan Drug Act [21 USC ee b 3 ] , which are foods formulated to be consumed or administered enterally under the supervision of a physician and are intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements based on recognized scientific principles are established by medical evaluation.
Medical foods are distinguished from FSDU by being targeted for distinctive nutritional requirements of disease conditions and by the intention for use under a physician's supervision the definition of an FSDU does not include a requirement for such supervision. In an advance notice of proposed rulemaking in the Federal Register of November 29, 7 , the FDA announced its intent to propose rulemaking in this still-evolving area.
First, it is considered adulterated if it presents a significant or unreasonable risk of illness or injury under the labeled conditions of use or, if conditions of use are not indicated, under usual conditions of use. Second, it is adulterated if it poses an imminent hazard to public safety or health. Third, it is adulterated if it contains a poisonous or deleterious substance that may render the product injurious.
A dietary supplement that contains a new dietary ingredient may also be adulterated unless the ingredient has a history of use as a food in a form that is not chemically altered or the manufacturer submits evidence of safety to the FDA 75 d before marketing the product. Foods may be classified into a range of legal and regulatory categories, which provides a great deal of flexibility for manufacturers and retailers who wish to develop functional foods.
As stated above, the primary determinant of the regulatory status of a food is its intended use, which is largely determined by the label and by labeling information accompanying the product. Several nutrients eg, vitamins A and C must be declared when they are in the product. Declaration of the remaining nutrients on the label is optional. FDA a Dietary Supplements.
Insel, P. Litwin, N. Colorado State University Extension. Food and Nutrition Series Health. Fact Sheet No. Onel, S. Regulatory Affairs Focus. You must be logged in to post a comment. Introduction A year into the COVID pandemic, consumer interest is on the rise for dietary supplement and functional food products that improve overall health.
Table 1. Examples of phytochemicals adapted from Insel et al. Neutralizes free radicals that may damage cells; bolsters cellular antioxidants defenses; can be made into vitamin A in the body.
Flavonoids Proanthocyanidins Cranberries, cocoa, apples, strawberries, grapes, wine, peanuts, cinnamon. Other documents 1. Press releases 2. Our Mission Statement. Bookmark page. Recommend page. Data Protection Declaration.
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