As stated on the bottom front of every product unit package: 

“This product is NOT a controlled or licenced drug, natural health product, nutraceutical, or dietary supplement”, or any other related product type requiring licencing."

These products are classified as manufactured food-type gummy confections, and NOT finished pills, capsules, or tablets, etc.   They do NOT contain controlled or licenced substances.   We do NOT make any explicit health claims or guarantees of any kind, stated on product labels or in marketing materials.

Regarding products, for which an explicit health IS made, on a label or in marketing materials, such products may require licencing, depending on the jurisdiction / country / state, where they are intended to be sold to consumers.   For example, in Canada, such products may only contain ingredients listed in the Natural Health Products Ingredients Database.   Any person, at any time, may submit a request to add a new ingredient to this database.   The description for any ingredient in the database, indicates if it is allowable.  

An ingredient is allowable, if it meets the requirements of ingredient Schedule #1, of applicable regulations.   Most allowable ingredients are classed as Item #2, of Schedule #1, of applicable regulations, which is as an “isolate”.   This means the ingredient is a naturally-occurring substance, and can be isolated from a naturally-occurring source.   Allowable ingredients are also those, which currently and presently are NOT listed in any Schedule of controlled drugs or substances, and NOT listed in any Schedule or List of prescription drugs or non-prescription drugs.      

[2] What kind of food-type products are these? 

These products are gummy confections, whose simplified definition is as follows:

“A “gummy” is a type of soft, chewable, candy or other sweet-tasting preparation (sweets), commonly found in North America and Western Europe.   Candy and sweets are formally known as confections, and more commonly known as confectionery.   In simplest terms, these gummy bars are soft, chewable candies and sweets.”

Manufactured food-type products are a broad category of products with various compositions, appearances, and sources, and are clearly identified, upon visual inspection, as NOT being finished pills, capsules, or tablets, etc.  

[3] Why are these products considered to be the “first of a kind”?

The formulation of the gummy bar, including the inclusion of beneficial amines in it (described below in questions [5] and [6]), along with the manufacturing process of producing the beneficial amines, are unique and being protected by CA 3,132,224 and CA 3,153,977, for intellectual property protection.   For something to be patent protected, it must be significantly different from what is currently available, such that it is considered a new invention.

The gummy bar can act as both a gummy, and a lozenge, when used as per the suggested consumption, indicated on the label, while current typical gummies or lozenges, function as a gummy OR lozenge.   In contrast to other gummies and lozenges, where the gummy or lozenge base consists of various solid and/or liquid sugars and/or carbohydrates, the base of our gummy bars consists of glycerol (glycerin) or diglycerol, and gelatin or whey protein, which are NOT sugars or carbohydrates.   Therefore, the base of our gummy bars is free of glucose sugar and carbohydrates.

[4] What is a “gummy bar”?

For our products, a “gummy bar” is a bar-shaped gummy, is classified as a food-type product, and considered as a gummy confection.

These products are gummy confections, whose simplified definition is as follows:

“A “gummy” is a type of soft, chewable, candy or other sweet-tasting preparation (sweets), commonly found in North America and Western Europe.   Candy and sweets are formally known as confections, and more commonly known as confectionery.   In simplest terms, these gummy bars are soft, chewable candies and sweets.”

For additional information, please see the previous question [2].

[5] What are “beneficial amines”?

For our products, “beneficial amines” are substances, which are produced naturally in the living, human body, via enzymes in digestion and metabolic processes, by decarboxylation of the 20 common essential and non-essential amino acid nutrients, obtained via a normal diet (essential amino acid nutrients) or produced from essential amino acid nutrients in the body via metabolic processes (non-essential amino acid nutrients).   Beneficial amines in our products are NOT controlled or licenced drugs.

For the beneficial amines in our products, both their hydrochloride salt form and free amine base form, ARE listed AS allowable, in the Natural Health Products Ingredients Database.   In the Database, they are classified under Schedule #1 and Item #2, as isolates, and therefore allowable.   For additional information on the Database, please see [1].   

Our definition of beneficial amines is limited to those produced from the 20 common essential and non-essential amino acid nutrients.   Our definition is also limited to selected amines produced from certain amino acid nutrients, within the group of 20 nutrients.   The selected amines include phenethylamine (2-phenethylamine) and GABA (gamma aminobutyric acid).   The beneficial amines are provided in our products as their stable, solid hydrochloride salts (indicated by “HCl” on the label), for stability and ease of consumption purposes. 

The beneficial amines used in our products, are produced in-house by the company, using a chemical synthesis manufacturing process, which was developed by our company founder, and is being patent protected, along with the gummy bar formulation, for intellectual property protection.

[6] It is stated in one of the marketing videos, that phenethylamine (2-phenethylamine) is a mild, natural stimulant, that GABA (gamma aminobutyric acid) is a mild, natural relaxant, and that GABA (gamma aminobutyric acid) is made from an amino acid nutrient.   Are these health claims?

 NO.

The statements that phenethylamine (2-phenethylamine) is a mild, natural stimulant, that GABA (gamma aminobutyric acid) is a mild, natural relaxant, and that GABA (gamma aminobutyric acid) is made from an amino acid nutrient, are NOT health claims.

These ARE statements of established scientific fact, based on the currently available, accumulated scientific research literature, for phenethylamine and GABA. 

There are NO descriptions of any specific or intended actions or results, to be expected, from consumption of phenethylamine and GABA, and individual results may vary.

[7] How were the contents of the beneficial amines phenethylamine and GABA, in your products, selected, and the suggested consumption route and amount consumed determined?

The contents of phenethylamine and GABA in our products, were selected, based on published, independent scientific human studies, in the currently available, accumulated scientific research literature, for phenethylamine and GABA.   In these studies, volunteer human test subjects orally swallowed and ingested certain amounts of phenethylamine and GABA, in either their free amine base, or hydrochloride salt form. 

The suggested consumption for these products, is based on how many times, the volunteer human test subjects orally swallowed and ingested certain amounts of phenethylamine and GABA, in either their free amine base, or hydrochloride salt form, in the referenced, published, independent scientific human studies, in the currently available, accumulated scientific research literature, for phenethylamine and GABA. 

The product labels indicate “can consume without food, or on empty stomach”, because, in the referenced, published, independent scientific human studies, in the currently available, accumulated scientific research literature, for phenethylamine and GABA, the volunteer human test subjects orally swallowed and ingested certain amounts of phenethylamine and GABA, in either their free amine base, or hydrochloride salt form, on empty stomachs and without food, as per the procedural protocols used in these studies.   The procedural protocols used in the referenced studies, of consuming phenethylamine and GABA, in either their free amine base, hydrochloride salt forms, were used to eliminate any potential effects, which the presence of food in the stomach and its consumption, may have had on the outcomes of the studies. 

If the consumer does not wish to place a slice of the gummy bar under the tongue, until melted and then swallowed, the slice can instead, simply be chewed and swallowed.

The actual contents of phenethylamine and GABA in our products, as important ingredients whose amounts are given on the product labels, are within the generally accepted range of 80 – 120% of the stated label amounts for such ingredients, for our gummy bars.

[8] What is the nature of the marketing campaign for your products? 

The marketing campaign for our products is based on the following 3 simple principles:

[1] The products ARE marketed to adults, and we do NOT recommend their use by children, using age 18 years as the legal threshold for adult age;

[2] The products ARE marketed to adults as LIFESTYLE marketing, with the central theme being that of self-suffiency. 

The statements: "Bring some activity to your day", "Bring some tranquility to your day", and "Bring some steady-as-it-goes to your day" ARE LIFESTYLE marketing general promotional tag lines, revolving around the central marketing theme of self-suffiency.   These are NOT, and are NOT intended to be or make any explicit health claims or guarantees of any kind, stated on product labels or in marketing materials.

[3] As the products are marketed via LIFESTYLE marketing, we do NOT make any guarantees or health claims regarding our products, and individual results may vary.

For our founding product family, as well as the company itself, the SE-Shield is the official trademark.   All other aspects of our product packaging design and marketing materials, are copyrighted.   These are part of our LIFESTYLE marketing campaign(s), and are NOT health claims.