The legal status of Geranamine – an alternative view
DSHEA makes plenty of provisions for the expansion and development of new ingredients. It liberally allows for compounds that are naturally occurring to be sold and marketed with and without a NDI. According to the plain language of the statute a NDI is NOT an approval, simply a notification. The law allows an ingredient to be eligible as a dietary supplement, if the following is true:
“(ff) The term “dietary supplement” –
- “(1) means a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients:
- “(A) a vitamin;
- “(B) a mineral;
- “(C) an herb or other botanical;
- “(D) an amino acid;
- “(E) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or
- “(F) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (A), (B), (C), (D), or (E);
The compound in question, is a natural constituent of Geraniums and was shown to occur in the oil extract of the flowers. Geraniums have been used as a food and supplement for thousands of years and most certainly the ingestion of Geranamine has been part of that. Therefore, there is a strong argument that the compound is a dietary supplement under the above section. The statute defines a “new dietary ingredient” as, “a dietary ingredient that was not sold in the United States in a dietary supplement before October 15, 1994.” Because geranamine was not sold as a dietary supplement prior to this date, we must then look to the following statute.
- “SEC. 413. (a) IN GENERAL.– A dietary supplement which contains a new dietary ingredient shall be deemed adulterated under section 402(f) unless it meets one of the following requirements:
- “(1) The dietary supplement contains only dietary ingredients which have been present in the food supply as an article used for food in a form in which the food has not been chemically altered.
- “(2) There is a history of use or other evidence of safety establishing that the dietary ingredient when used under the conditions recommended or suggested in the labeling of the dietary supplement will reasonably be expected to be safe and, at least 75 days before being introduced or delivered for introduction into interstate commerce, the manufacturer or distributor of the dietary ingredient or dietary supplement provides the Secretary with information, including any citation to published articles, which is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing such dietary ingredient will reasonably be expected to be safe.
In §413 (a) (1), the statute states that the new dietary ingredient cannot be found adulterated if it has been present in the food supply where the food and subsequently the ingredient has not been chemically altered. Geranium has been consumed by humans in food and dietary supplements for hundreds, if not thousands of years. Concentration, extraction and standardization are not considered chemical alterations. Chemical alteration has a very specific meaning according to a very respected PHD in biochemistry. In a conversation I had with him he stated, “Chemical alteration can mean only one thing and that is the addition or subtraction of a covalent bond. Ionic bonding is not a chemical alteration where I’m from”. So, is “synthetic” geranamine chemically altered? At least according to one noted PHD in biochemistry, NO! So, this leads us to the question of whether the law makes provisions for bioidentical products to be sold as dietary ingredients. Is Vitamin C, made in the lab illegal because it wasn’t extracted from fruit? Not traditionally, and there is certainly room in DSHEA, and it’s congressional intent, to support this. Additionally, in the industry we see this all the time, Ester-C ™ for example is ionically bonded vitamin C with an ester, as is “buffered” vitamin C. Additionally, DL-alpha-tocopherol is a form of vitamin E extracted from coal, and it is for sale in every drugstore and supermarket in the country. So, simply because something is made in a lab, doesn’t necessarily make it illegal, since ingredients are often scaled up and produced with differing methods. To quote an opinion paper on the subject by Covinton and Burling:
“It is clear that Congress intended this to be an extremely broad definition. Changes in manufacturing processes do not convert an old dietary ingredient into a new dietary ingredient. New salts and esters of pre-1994 dietary ingredients do not create new dietary ingredients. Nor do new sources of old dietary ingredients become new dietary ingredients.”
Additionally, on the inclusion of new dietary ingredient submissions, Covington and Burling expressed, based on their extensive research of the congressional testimony, that:
“Any substance found naturally in the food supply — at any level, and regardless of prior safety evaluation — is excluded from the requirement of a 75-day notice. Synthetic or recombinant nature-identical versions of these ingredients are also excluded. The only limitation is that the ingredient must not have been produced by chemically altering the food in which it was found.”
So, the fear mongering crowd is once again ignorant of the law they worked so hard to enact. The truth is that there is support to find that geranamine is more than reasonably safe when used at sane levels in dietary supplements. The literature supports its occurrence in geraniums, and the HCL version uses an ionic bond that is clearly not a chemical alteration.