Different articles have been published to clarify the terms of the legal action made and to inform consumers about the mislabeling found in these brands owing to SAM-e ion content per tablet (determined by HPLC) far below the label claims (many of them had results that were below 80% of the SAM-e ion content per tablet claimed on the label).
As a market leading producer of SAMe, we believe it is essential to point on the key aspects of the ingredient to clarify the requirements needed to offer high quality dietary ingredients and finished products.
As a matter of fact, the quality level of SAM-e dietary ingredient is key to have an effective and reliable finished product on the market.
SAM-e is naturally unstable and sensitive to moisture and heat.
In its native form it is an ionic chiral molecule – the (S,S) stereoisomer – which is extremely labile and degrades rapidly.
Historically, it became industrially available in the nutraceutical market as an ingredient only after the SAM-e ion was stabilised as a salt - like the disulfate p-toluenesulfonate - and as a finished product in the form of enteric-coated tablets.
Both processes (salt and tablet production) are still protected by patents granted to Gnosis by Lesaffre.
The enteric coating allows the dietary ingredient to be released in the intestine (duodenum) to optimise gastrointestinal tolerability and absorption; at the same time, it protects the dietary ingredient (contained in the tablet’s core) from degradation by avoiding contact with humid air.
The tablet manufacturing process requires specific environmental conditions and a high level of industrial expertise, together with high quality raw materials.
Gnosis by Lesaffre knows SAMe very well: we have been manufacturing both pharmaceutical and nutraceutical ingredients for more than 30 years.
The industrial manufacturing of both grades is done in a GMP manufacturing facility with a controlled supply chain.
During this time, Gnosis by Lesaffre has never stopped R&D development on SAM-e products, aiming to provide new and appealing stabilised formulations (as powders and/or granules), to be presented in oral dosage forms (such as capsules and sachets) and containing useful combination of SAM-e with other active ingredients.
These newly and suitable stabilised 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 formulating a new finished product” said Lorena Carboni, SAMe Product Manager of the company.
“These aspects can never be underestimated when it comes to offering a good product. We believe that any kind of action to guarantee the quality, efficacy and safety of a dietary supplement should always be considered a positive one.”