What Are the Different Types of Food Supplements?

The U.S. Food and Drug Administration (FDA) has announced the Dietary Supplement Health and Education Act (DSHEA), which states that a dietary supplement is intended to supplement a dietary product (not tobacco), which may contain One or more of the following dietary ingredients, a vitamin, a mineral, an herb (herbal) or other plant, an amino acid, a food ingredient to increase the total daily intake to supplement the diet, or A concentrate, metabolite, ingredient, extract or combination product of the above ingredients. It also includes approved new drugs, vitamins or biologics that have been marketed as dietary supplements or foods before being approved, issued, or licensed. DSHEA defines dietary supplements as their composition and labeling requirements: the product form can be pills, capsules, tablets, or liquids; the product cannot replace ordinary food or the only variety in the diet, and the product is labeled "dietary supplements" ^{[ 1]} .

The U.S. Food and Drug Administration (FDA) has announced the Dietary Supplement Health and Education Act (DSHEA), which states that a dietary supplement is intended to supplement a dietary product (not tobacco), which may One or more of the following dietary ingredients, a vitamin, a mineral, an herb (herbal) or other plant, an amino acid, a food ingredient to increase the total daily intake to supplement the diet, or A concentrate, metabolite, ingredient, extract or combination product of the above ingredients. It also includes approved new drugs, vitamins or biologics that have been marketed as dietary supplements or foods before being approved, issued, or licensed. DSHEA defines dietary supplements as their composition and labeling requirements: the product form can be pills, capsules, tablets, or liquids; the product cannot replace ordinary food or the only variety in the diet, and the product is labeled "dietary supplements" ^{[ 1]} .

Specific requirements for dietary supplements

1. The product can be in the form of pills, capsules, tablets or liquids.

2, can not replace ordinary food or as the only variety of diet.

3.Identified as "Dietary Supplements"

4. An approved new drug, a licensed antibiotic, or a licensed biologic, such as a product that has been marketed as a dietary supplement or food before it was approved, licensed, or licensed, respectively.

Dietary Supplements Master Plan

Announcement of Dietary Supplement Program

On November 4, the FDA announced three major regulatory initiatives aimed at further implementing the Dietary Supplement Health and Education Act of 1994 (DSHEA). These plans-a regulatory strategy, an open public meeting, and a draft industry guidance document-are important steps the FDA has taken to implement DSHEA.

"These plans improve the approach the FDA is taking to regulate dietary supplements," said Lester M. Crawford, Acting Director of the FDA. "We now have a clear road sign shared with the dietary supplement industry, while giving consumers a higher level of assurance regarding the safety of dietary supplements and the reliability of their trademarks."

Purpose of the dietary supplement program

The FDA plans to improve the transparency, predictability, and consistency of its scientific evaluation and regulatory action by opposing unsafe dietary supplements and manufacturing unauthorized, false, or misleading claims to protect consumers. FDA will continue its ongoing efforts to monitor and evaluate product safety, ingredient safety and product labeling and ensure product quality. The FDA has issued a Federal Register notice of this public meeting, and two notices describing other programs.

Dietary Supplements First Plan

In the first plan, a regulatory strategy is that the FDA will work with federal and other partners to improve the evidence base used by the FDA to develop safety and enforcement decisions on dietary ingredients and dietary supplements ( evidentiary base). Those partners include the National Institutes of Health Office of Dietary Supplements and the National Center for Complementary and Alternative Medicine, and the National Toxicology Program of the Department of Health and Human Services ( National Toxicology Program), the National Center for Natural Products Research at the University of Mississippi, the FDA's National Center for Toxicological Research, and others.

The FDA will also implement a transparent, systematic and predictable process to evaluate the safety of dietary ingredients and dietary supplements. The process begins with a "signal detection" (identifying an issue of interest). One possible safety concern signal can come from: federal, state and local counterparts, adverse event reports, foreign regulatory actions, media reports, information from consumer groups, and expert consultations. When the quality or quantity of these signals indicates a possible public health problem, the FDA will therefore seek signal input from an independent third party for review. FDA's regulatory action will be based on all available scientific evidence, including the substance's pharmacology, scientific literature, adverse event reports, and evidence-based review. FDA has a variety of options to implement its public health mission, including: making an unreasonable risk determination, issuing public health advice, educating consumers, conducting research, and requiring label changes.

According to DSHEA, dietary supplements do not require FDA approval before they are marketed. However, according to the law, certain new dietary ingredients (NDI) (ie, dietary ingredients not listed in the United States before October 15, 1994), A pre-market safety notice to the FDA is required.

Dietary Supplement Second Plan

To facilitate the effective implementation of this requirement, the FDA has announced its second plan, a public meeting on November 15, 2004, which aims to determine the type of evidence that manufacturers provide to the FDA in a new dietary ingredient notification , Quantity and quality for public comment.

The FDA does not anticipate any immediate changes to its enforcement procedures. According to the FDA's clarification on the substances that make up a new dietary ingredient, a notification must be submitted to it, and the FDA will continue to communicate with the enterprise. In addition, the FDA will fully review the comments it has received from public meetings before any next step is taken.

The FDA is committed to taking action on unsafe products. For example, a certain fter identified a product that contains androstenedione that poses significant health risks and lacks NDI notifications. The FDA issued warning letters to 23 companies in March 2004 asking them to stop distributing as dietary supplements. Products that contain androstenedione are warned that they may face further enforcement action if appropriate measures are not taken.

Another aspect of this strategy is to ensure product quality. The plan addresses the need to establish industry-wide standards to help ensure that dietary supplements are consistently produced in terms of identity, purity, quality, concentration, and composition.

On March 13, 2003, the FDA issued a proposed rule regarding current Good Manufacturing Practice requirements (cGMP) for dietary supplements. Currently, the FDA is reviewing and evaluating more than 1,600 pages of comments. The release of a cGMP final rule is one of FDA's highest priorities.

As the FDA is committed to protecting consumers against false or misleading claims including unsubstantiated claims, dietary supplements will continue to be monitored and evaluated by the FDA, and enforcement action will be taken when appropriate. The measure will include surveillance logo claims, including in accompanying text such as flyers, brochures and catalogs, and claims in Internet logos.

Other measures include: identifying and taking enforcement action against products whose label fails to reveal material facts; targeting products that pose the greatest risk to consumers; obtaining and analyzing samples of dietary supplements in the market to verify their content The content is consistent with the labeling; and the Supplement Facts panels are reviewed to determine if substances listed as dietary ingredients in dietary supplements can be legally marketed.

Dietary Supplement Third Plan

The third plan seeks comments on draft guidance documents on the quantity, type, and quality of evidence, reflecting FDA's full implementation of DSHEA's obligations. Under Section 403 (r) (6) of the Federal Food, Drug, and Cosmetic Act (403 (r) (6) of the Federal Food, Drug, and Cosmetic Act), manufacturers should have proof of a claim Evidence, such as structural function claims. Although the DSHEA's revised Federal Food, Drug, and Cosmetic Act requires certification of such claims, it does not define the term. The draft guidance document specifies manufacturers' flexibility in the precise amount and type of evidence that constitutes sufficient substantiation.

Providing a standard for certification may also help protect consumer confidence in these products.

During the development of this draft guideline, the FDA reviewed: regulations, case law, the Federal Trade Commission's (FTC) guidelines for validating claims for dietary supplements in advertising, and from diet Recommendations from the Commission on Dietary Supplement Labels.

The FTC has typically applied a "strong and credible scientific evidence" proof of claims made in advertising for dietary supplements. FDA plans to apply a standard consistent with FTC's approach when it reviews labels and other claims.

"This guidance issued by the FDA today sends a clear and powerful signal to sellers: Claims about the benefits of dietary supplements, wherever they appear, must be true and confirmed by high-quality scientific evidence," FTC Chairman Deborah Platt Majoras. "Today's FDA action has undoubtedly initiated the efforts of our two agencies to unite against false or unfounded claims."

Whether consumers buy dietary supplements to improve their appearance, promote general health, or help them maintain a healthier lifestyle, consumers can be victims of products that trick their money , Or keep them away from products that are exactly what they seek.

In fact, on October 22, 2004, the FDA issued eight warning letters to dietary supplement distributors who made unfounded claims on the Internet to promote dietary supplements for weight loss. Because those claims lack sufficient evidence, they are considered false or misleading; therefore, these products are misbranded.

The FDA also sent a warning letter to major dietary supplement retailers that day stating that products labeled as baseless claims are mislabeled, and that the FDA may take enforcement action on mislabeled products in their possession. FDA plans to launch an inspection process for retail establishments to identify products that have unsubstantiated claims in their labels.

"By pursuing illegal products, the FDA will continue to protect consumers," Dr. Crawford said.

Comment on dietary supplements

The FDA is seeking comments from the public and businesses on the regulatory strategy and topics that will be discussed at a public meeting on November 15, 2004. Written comments will be received 60 days before the publication date in the Federal Register and can be mailed to the FDA at Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061 , Rockville, MD 20852, United States.

Dietary supplement health standards

Dietary nutritional supplements for general food status can comply with the requirements of the "Management Regulations on Food Nutrition Labelling" issued by the Ministry of Health in 2008, with nutrition or nutritional ingredient functional claims on product labels. Health foods approved by the health administrative department can only claim approved specific health functions, and advertisements need to be approved by the State Drug Administration. And nutrient supplements can only claim to supplement (specifically) nutrients.

Dietary supplement health hazards

US scientists point out that there is no strong evidence that dietary supplements can reduce cancer risk in healthy users. Antioxidants such as beta-carotene, vitamin C, and vitamin E in dietary supplements can even produce harmful biological effects, leading to cancer. Ingesting antioxidants by taking supplements can be a double-edged sword. This compound can act as an oxidative enhancer in humans or interfere with protective processes such as inducing apoptosis ^[1] .