Biocentric Energy Holdings, Inc. (BEHL)

[TheAnswer]

First, they don't have an algae derived product for sale yet. Since omega 3 is a gras, the company that actually produces the product notifies the fda that this is added to their product. BEHL doesn't need any FDA approval. If anyone does, it's the people manufacturing the product like sports drinks or whatever the omega 3 is being added to. Here's some information from the fda website. First sites that come up on a google search. Cyanotech sells their own products, and that is why they get this gras approval by the fda. It's not a difficult process for companies to get this.


http://www.thesmartmama.com/fda-gras-and-what-does-algae-fungus-hexane-have-to-do-with-baby-formula/

To explain that, let me first explain how the FDA regulates food contact substances. Food contact substances are those items that are not directly added to food, but are in contact with food, such as packaging materials. If a new food contact substance is proposed, or a new use of an existing food contact substance is proposed, a manufacturer must give the FDA notice of it unless there are existing regulation related to the used or the substance or use is considered “Generally Recognized as Safe” (or “GRAS”).

This voluntary GRAS notification program was proposed in 1997. In 1997, the FDA abolished its existing procedure by which it approved petitions to designate substances because the FDA did not have the resources to review and approve the petitions. Under the GRAS notification process, a manufacturer informs the FDA that it has determined that a substance or use is GRAS, as opposed to petitioning the FDA to approve the use or a substance is GRAS. As explained by the FDA, if the manufacturer’s determination is correct, the use or the substance is not subject to any legal requirement for FDA review and approval. In fact, since the GRAS notification process is voluntary, a manufacturer may market the substance or use without informing FDA if the manufacturer determines it is GRAS or, if FDA is so informed, while FDA is reviewing that information. Sounds crazy, doesn’t it? As long as a manufacturer determines the food contact substance or use is GRAS, it can go ahead and market it.

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Dietary Supplements
Consumer Information

Dietary Supplements - Q&A Overview of Dietary Supplements Tips For The Savvy Supplement User: Making Informed Decisions And Evaluating Information Tips for Older Dietary Supplement Users - Overview of Dietary Supplements
What is a dietary supplement?
Congress defined the term "dietary supplement" in the Dietary Supplement Health and Education Act (DSHEA) of 1994. A dietary supplement is a product taken by mouth that contains a "dietary ingredient" intended to supplement the diet. The "dietary ingredients" in these products may include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites. Dietary supplements can also be extracts or concentrates, and may be found in many forms such as tablets, capsules, softgels, gelcaps, liquids, or powders. They can also be in other forms, such as a bar, but if they are, information on their label must not represent the product as a conventional food or a sole item of a meal or diet. Whatever their form may be, DSHEA places dietary supplements in a special category under the general umbrella of "foods," not drugs, and requires that every supplement be labeled a dietary supplement.

What is a "new dietary ingredient" in a dietary supplement?
The Dietary Supplement Health and Education Act (DSHEA) of 1994 defined both of the terms "dietary ingredient" and "new dietary ingredient" as components of dietary supplements. In order for an ingredient of a dietary supplement to be a "dietary ingredient," it must be one or any combination of the following substances:

a vitamin,
a mineral,
an herb or other botanical,
an amino acid,
a dietary substance for use by man to supplement the diet by increasing the total dietary intake (e.g., enzymes or tissues from organs or glands), or
a concentrate, metabolite, constituent or extract.
A "new dietary ingredient" is one that meets the above definition for a "dietary ingredient" and was not sold in the U.S. in a dietary supplement before October 15, 1994.



What is FDA's role in regulating dietary supplements versus the manufacturer's responsibility for marketing them?
In October 1994, the Dietary Supplement Health and Education Act (DSHEA) was signed into law by President Clinton. Before this time, dietary supplements were subject to the same regulatory requirements as were other foods. This new law, which amended the Federal Food, Drug, and Cosmetic Act, created a new regulatory framework for the safety and labeling of dietary supplements.

Under DSHEA, a firm is responsible for determining that the dietary supplements it manufactures or distributes are safe and that any representations or claims made about them are substantiated by adequate evidence to show that they are not false or misleading. This means that dietary supplements do not need approval from FDA before they are marketed. Except in the case of a new dietary ingredient, where pre-market review for safety data and other information is required by law, a firm does not have to provide FDA with the evidence it relies on to substantiate safety or effectiveness before or after it markets its products.

Also, manufacturers need to register themselves pursuant to the Bioterrorism Act with FDA before producing or selling supplements. In June, 2007, FDA published comprehensive regulations for Current Good Manufacturing Practices for those who manufacture, package or hold dietary supplement products. (See Current Good Manufacturing Practices (CGMPs) - Dietary Supplements) These regulations focus on practices that ensure the identity, purity, quality, strength and composition of dietary supplements.

When must a manufacturer or distributor notify FDA about a dietary supplement it intends to market in the U.S.?
The Dietary Supplement Health and Education Act (DSHEA) requires that a manufacturer or distributor notify FDA if it intends to market a dietary supplement in the U.S. that contains a "new dietary ingredient." The manufacturer (and distributor) must demonstrate to FDA why the ingredient is reasonably expected to be safe for use in a dietary supplement, unless it has been recognized as a food substance and is present in the food supply.

There is no authoritative list of dietary ingredients that were marketed before October 15, 1994. Therefore, manufacturers and distributors are responsible for determining if a dietary ingredient is "new", and if it is not, for documenting that the dietary supplements its sells, containing the dietary ingredient, were marketed before October 15, 1994. For more detailed information, see new dietary ingredients.

What information must the manufacturer disclose on the label of a dietary supplement?
FDA regulations require that certain information appear on dietary supplement labels. Information that must be on a dietary supplement label includes: a descriptive name of the product stating that it is a "supplement;" the name and place of business of the manufacturer, packer, or distributor; a complete list of ingredients; and the net contents of the product.

In addition, each dietary supplement (except for some small volume products or those produced by eligible small businesses) must have nutrition labeling in the form of a

"Supplement Facts" panel. This label must identify each dietary ingredient contained in the product.

Must all ingredients be declared on the label of a dietary supplement?
Yes, ingredients not listed on the "Supplement Facts" panel must be listed in the "other ingredient" statement beneath the panel. The types of ingredients listed there could include the source of dietary ingredients, if not identified in the "Supplement Facts" panel (e.g., rose hips as the source of vitamin C), other food ingredients (e.g., water and sugar), and technical additives or processing aids (e.g., gelatin, starch, colors, stabilizers, preservatives, and flavors). For more details, see: Federal Register Final Rule - 62 FR 49826 September 23, 1997.

Are dietary supplement serving sizes standardized or are there restrictions on the amount of a nutrient that can be in one serving?
Other than the manufacturer's responsibility to ensure safety, there are no rules that limit a serving size or the amount of a nutrient in any form of dietary supplements. This decision is made by the manufacturer and does not require FDA review or approval.

http://www.fda.gov/Food/DietarySupplements/ConsumerInformation/ucm110417.htm#getinfo

Where can I get information about a specific dietary supplement?
Manufacturers and distributors do not need FDA approval to sell their dietary supplements. This means that FDA does not keep a list of manufacturers, distributors or the dietary supplement products they sell. If you want more detailed information than the label tells you about a specific product, you may contact the manufacturer of that brand directly. The name and address of the manufacturer or distributor can be found on the label of the dietary supplement.