The Dalphy France herbal medicine laboratory is suspended. A santion justified by the non-respect of the conditions of manufacture but also the sale of products based on prohibited plants.
DALPHY France and its “laboratory” DYNAFLORE, are suspended until their return to the nails. The company markets phytotherapy products without authorization, some of which are banned, which has attracted the attention of the Medicines Safety Agency (ANSM).
DYNAFLORE will no longer be able to manufacture, import or market its phytotherapy specialties. The prescription, advertising and dispensing of herbal medicines are also prohibited. This suspension will be effective until brought up to standard, announces the ANSM in its decision of April 11. The products sold until now are considered as drugs by the ANSM. They must therefore be sold within a pharmaceutical establishment, authorized by the ANSM, and are subject to the monopoly of pharmacists. DALPHY France and its DYNAFLORE laboratory do not have an establishment. They will have to do this in order to resume their activity.
Two forbidden plants
This is not the only flaw revealed by the judicial investigation and searches. Herbal medicine sold are subject to marketing authorization (AMM). Those sold by DYNAFLORE have not been subject to such a measure. More worrying: the premises are not suitable for the manufacture and packaging of drugs. The current conditions expose a risk of “contamination and degradation” of products, underlines the ANSM. Another thorny point: the plants received are not subject to macroscopic control, the batches manufactured and distributed do not allow traceability and the documentation allowing quality control “is non-existent. “
The summit is reached when we peel the catalog of specialties offered by DYNAFLORE. Two plants are prohibited on French soil. Ephedra contains ephedrine, considered a dopant and banned since 2003. This plant used as a nasal decongestant or stimulant presents “a serious risk to public health. Hoodia gordonii, a traditional appetite suppressant in Namibia, has also been banned since 2012. Several cases of liver, heart, muscle and neurological damage have been reported according to the ANSM. The Agency recalls that several warning letters were sent to DALPHY France and DYNAFLORE, and were not followed up, which explains this firm decision.
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