In the last weeks, a lawsuit action against some independently tested “low quality SAMe brands” sold online, is getting attention by the US food supplements industry (http://www.truthinadvertising.org/wp-content/uploads/2019/07/Ginsberg-v-Vitamins-Because-complaint.pdf).
Different articles have been published in order to clarify the terms of the legal action made, and to inform consumers about the mislabeling found in these brands, due to SAM-e ion content per tablet (determined by HPLC) far below the label claims (many of them had results which were below 80% of the SAM-e ion content per tablet claimed on the label).
As market leading producer of SAMe, we believe it is essential to point on the key aspects of the ingredient in order to clarify the requirements to offer high quality of the dietary ingredient supplied and the finished products as well. As a matter of fact, the quality level of SAM-e dietary ingredient is the key to have an effective and reliable finished product on the market.
SAM-e is naturally unstable, mainly sensitive to moisture and heat. In its native form it is a ionic chiral form – the (S,S) stereoisomer – extremely labile and rapidly degrading. Historically, it became industrially available in the nutraceutical market as ingredient only after the stabilization of SAM-e ion as salt – like the disulfate p-toluenesulfonate – and as finished product in the form of enteric-coated tablets. Both processes (salt production and tablets manufacturing) are still protected by granted patents under Gnosis by Lesaffre know how. The enteric coating allows the dietary ingredient to be released in the intestine (duodenum), to optimize gastrointestinal tolerability and absorption, and in the meantime protects the dietary ingredient (contained in the tablet’s core) from degradation avoiding the contact with air humidity.
The manufacturing process of tablets requires specific environmental conditions and a high industrial expertise, together with a high quality of the raw materials chosen. Gnosis by Lesaffre knows very well SAMe aspects and issues: we are the historical manufacturer of both pharmaceutical and nutraceutical ingredients, by more than 30 years. The industrial manufacturing of both grades is carried out in a GMP manufacturing facility with a controlled supply chain.
During these years Gnosis by Lesaffre has never stopped R&D development on SAM-e products, with the challenge to provide new and appealing stabilized formulations (as powders and/or granules), to be presented in oral dosage forms (like capsules and sachets) and containing useful combination of SAM-e with other active ingredients. These newly and suitable stabilized formulations are available under the umbrella of Adonat®, the brand name of SAMe Gnosis by Lesaffre. “The case of “low quality SAMe brands” brings to light the strategic quality aspects that must be considered before to formulate a new finished product” said Lorena Carboni, SAMe Product Manager of the company. “These aspects can never be underestimated to offer a good product to the market. We believe that any kind of action moved to guarantee the quality, the efficacy and the safety of a dietary supplement should always be considered positive”.
Adonat® SAMe dietary ingredient is produced by a biofermentation process of Saccharomyces cerevisiae yeast cultures and is purified without the use of solvents.
The proprietary patented manufacturing process allows to achieve the highest content of (S,S) active diastereoisomer, ≥ 75 % (“USP Dietary Supplement Monograph” requires only ≥ 60.0 %). Gnosis by Lesaffre is the only manufacturer in the world that supply high quality SAMe bulk powder, enteric coated tablets and stabilized oral dosage forms, for nutritional applications.• Direct from fermentation of Saccharomyces cerevisiae yeast cultures
• Highest content of (S,S) active diastereoisomer, ≥ 75 % (“USP Dietary Supplement Monograph” requires only ≥ 60.0 %)
• Intellectual property with more than 10 granted patents on SAMe
• Kosher and Halal Certified, GMP Manufacturing, FDA Inspected