[1] Is this product a controlled or licenced drug, natural health product, nutraceutical, dietary supplement, or cannabis product?

NO.

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 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 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 or non-prescription drugs.  Allowable ingredients ARE those listed in the Natural Health Products Ingredients Database.   ALL ingredients in SE Steady ARE listed in the Natural Health Products Ingredients Database. 

[2] What kind of food-type product is this? 

This product is a manufactured food gummy confection, or simply a "gummy", 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, gummies are soft, chewable candies and sweets.”

Manufactured food 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 is this product considered to be the “first of its kind”?

The formulation of the gummy bar, including the inclusion of GABA HCl  in it (described below in questions [5] and [6]), along with the manufacturing process of producing it, are unique and being protected by Canadian Patents 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.

In contrast to other gummies, where the gummy 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 product, a “gummy bar” is a bar-shaped gummy, is classified as a manufactured food product, and considered as a gummy confection.

This product is a 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, this gummy bar is a soft, chewable candy and sweet.”

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

[5] What are GABA and GABA HCl?

GABA, or Gamma-Aminobutyric Acid, is the natural relaxation neurochemical.   GABA HCl, or Gamma-Aminobutyric Acid Hydrochloride, is the more-water-soluble hydrochloride salt of GABA.  BOTH are listed 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].    

GABA is one member of a diverse group of natural amine 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).   

[6] It is stated that GABA is the natural (naturally-occurring) relaxation neurochemical.   Is this a health claim?

NO.

This is a statement of established scientific fact, based on the currently available, accumulated scientific research literature, for GABA.  

[7] How was the amount of GABA in the SE Steady gummy bar, the suggested consumption route, and and amount consumed determined?

These were determined, based on published, independent scientific human studies, in the currently available, accumulated scientific research literature.   In these studies, volunteer human test subjects orally swallowed and ingested certain amounts of GABA, in either its free amine base, or hydrochloride salt form.  

The suggested consumption is based on how many times, the volunteer human test subjects orally swallowed and ingested certain amounts of GABA, in either its free amine base, or hydrochloride salt form, in the referenced, published, independent scientific human studies, in the currently available, accumulated scientific research literature, for 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 GABA, the volunteer human test subjects orally swallowed and ingested certain amounts of GABA, in either its free amine base, or hydrochloride salt form, on an empty stomach and without food, as per the procedural protocols used in these studies.  

The procedural protocols used in the referenced studies, of consuming GABA, in either its free amine base or 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.  

The actual content of GABA, as an important ingredient whose amount is given on the product label, should be within the generally accepted range of 80 – 120% of the stated label amount. 

[8] What is the nature of our marketing campaigns? 

Our marketing campaigns are based on the following 3 simple principles:

[1] The product IS 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 product IS marketed to adults as LIFESTYLE marketing.

[3] As the product is marketed via LIFESTYLE marketing, we do NOT make any guarantees or health claims regarding our product, and individual results due to its consumption, may vary.