Botanical diet pills, also known as herbal diet supplements, have gained popularity as natural alternatives for weight management. These supplements contain ingredients derived from plants, plant parts, or plant extracts and are intended to supplement the diet. While botanical preparations can impact health, it’s essential to understand their ingredients, regulations, and safety considerations.
Definition and Regulation of Dietary Supplements
In the United States, the Dietary Supplement Health and Education Act (DSHEA) of 1994 defines a "dietary supplement" as a product intended for ingestion that contains a "dietary ingredient" to supplement the diet. Dietary supplements come in various forms, including pills, tablets, capsules, gummies, softgels, liquids, and powders.
Under DSHEA, the Food and Drug Administration (FDA) does not approve dietary supplements before they are marketed. However, manufacturers and distributors are responsible for ensuring that their dietary supplements are not adulterated, misbranded, or otherwise in violation of federal law. They must also adhere to current good manufacturing practices (CGMPs) to ensure the identity, purity, quality, strength, and composition of their products.
If a dietary supplement contains a new dietary ingredient (NDI) that is not present in the food supply as an article used for food in a form in which the food has not been chemically altered, the manufacturer or distributor must notify FDA at least 75 days before introducing the product into interstate commerce. This notification must include information on the basis of which the firm has concluded that the NDI-containing dietary supplement will reasonably be expected to be safe.
Labeling Requirements
FDA regulations require dietary supplement labels to include specific information, such as:
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- Product name and a statement that it is a "dietary supplement" (or equivalent term).
- Name and place of business of the manufacturer, packer, or distributor.
- Nutrition labeling in the form of a "Supplement Facts" panel (with some exceptions).
- A list of "other ingredients" not declared in the Supplement Facts panel.
- Net quantity of contents.
The Supplement Facts panel must list the serving size, number of servings per container, each dietary ingredient in the product, and the amount of each dietary ingredient per serving (unless part of a proprietary blend). Ingredients not listed on the Supplement Facts panel must be listed in the "Other Ingredients" list beneath, which may include sources of dietary ingredients, other food ingredients, food additives, and color additives.
Safety and Potential Risks
Botanical preparations, like herbal supplements, can impact health. While some may aid health, there is variability in their effectiveness depending on individual factors, dosages, and purity levels.
Manufacturers and distributors must record, investigate, and forward to FDA any reports they receive of serious adverse events associated with the use of their products. FDA evaluates these reports and other adverse event information to identify early signals that a product may present safety risks to consumers.
The National Toxicology Program (NTP) is conducting studies to identify the potential harm of short and long-term exposure to botanical dietary supplements, which may provide toxicology data and help in determining the safety or risk of certain supplements.
Mycotoxins, toxic compounds produced by fungi, can be found in botanical roots and pose a risk to consumers. Determination of mycotoxins such as fumonisin B1 in botanical roots is crucial for ensuring the safety of botanical diet pills.
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Teucrium chamaedrys is one botanical ingredient with potential adverse effects.
FDA and FTC Oversight
FDA is responsible for enforcing the laws and regulations governing dietary supplements, including safety, quality, and labeling. The Federal Trade Commission (FTC) regulates advertising for dietary supplements, including infomercials. FDA and FTC share responsibility for the oversight of dietary supplements and related promotion, with FDA generally responsible for safety, quality, and labeling, and FTC generally responsible for advertising.
FDA considers advertising when evaluating the intended use of a product labeled as a dietary supplement. The agency can take enforcement actions against dietary supplements and firms if they identify violations.
Claims on Dietary Supplement Labels
Dietary supplement labels can include health claims (claims about the relationship between a dietary ingredient and reduced risk of disease), structure/function claims (claims about effects on a structure or function of the human body), and nutrient content claims (claims characterizing the level of a nutrient in a dietary supplement).
Structure/function claims, claims of a benefit related to a classical nutrient deficiency disease, and claims of general well-being must be accompanied by a disclaimer informing consumers that FDA has not evaluated the claim. The manufacturer must also have substantiation that the claim is truthful and non-misleading.
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Recommendations for Consumers
Before purchasing or using a dietary supplement, consumers should:
- Talk to their doctor, pharmacist, or other health care professional.
- Carefully read the label of any dietary supplement they are considering using.
- Report any harmful effects or illnesses (adverse events) to their health care provider immediately.
- Report instances of product problems to FDA using the Safety Reporting Portal.
Research and Resources
The National Institutes of Health’s Consortium for Advancing Research on Botanical and Other Natural Products (CARBON) program is actively exploring the potential of botanical ingredients. Publications are available that provide information on the safety assessment of botanical dietary supplements, including challenges and recommendations for assessing their safety, identifying toxic constituents, and evaluating their absorption, distribution, metabolism, and excretion.
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