On October 30 last year, Mexico's Federal Commission for the Protection Against Sanitary Risks (COFEPRIS) implemented guidelines and criteria to assess the use of cannabis and its derivatives in foods, beverages and supplements, opening up permits for cannabis-based products with low THC (tetrahydrocannabinol) levels to enter the market. Less than six months later, in March this year, COFEPRIS revoked these guidelines.
The Ministry of Health body revoked guidelines for a number of reasons, citing that they contravened the decree that allowed for medical cannabis in the country; that the guidelines had not been published in the Official Journal of the Federation; and that they did not have approval of the Foreign Trade Commission therefore contravening customs tariff regulations.
“Right now in Mexico, it's kind of a standby situation,” said David Pineda Ereño, managing director of DPE International Consulting.
“The government has revoked the guidelines but there are, both from the private sector and also from the side of the government, considerations to develop a new regulatory instrument,” Pineda Ereño told NutraIngredients-LATAM.
Whether this would be in the form of new guidelines or a regulation remained unclear, he said, but it “could be expected” that this would happen soon, providing clarity on use of cannabis in the future.
“Then we'll see what the current standing of the government will be – if they want to focus only on the use of cannabis for medicinal purposes or still allow for the use in food and food supplements.
“...What we need to see also, is what the outcome will be of the re-evaluation on those permissions that have been granted; we will see if they can still continue using them or not,” he said.
'Everybody is monitoring this very carefully'
Pineda Ereño said within the first two months of the guidelines being implemented in Mexico, more than 60 permits were granted to companies for use of cannabis in foods and supplements. But, he said very few of these were major multinationals.
“[The multinationals] were very interested in investing in this but they were waiting to see how this was going to develop. ...They were looking at it first, without jumping into it.” The move to authorize use of cannabis in foods and supplements, Pineda Ereño, was considered relatively “exceptional”, so the majors were just waiting for “legal certainty”.
“Any company that invests heavily on an ingredient or product; they first want to make sure that legally it's going to be successful.”
The supplements companies that did move, getting permits and bringing products to market, he said, were mainly local, with a few from the US, Canada, and Spain.
However, the revocation of these guidelines and what might happen next, Pineda Ereño said, was important and of interest to all companies, including those watching from the sidelines and those with products already on the market.
“Everybody is monitoring this very carefully,” he said.
COFEPRIS uncertainty – another 'wait and see'
What also had be considered within this “transition situation”, Pineda Ereño said, were uncertainties within Mexico's Ministry of Health, and in particular, COFEPRIS.
“Right now, one of the main objectives of the current government is to cut costs in Mexico drastically and they are looking at COFEPRIS as one of the areas to cut costs,” Pineda Ereño said.
“It still remains to be seen whether COFEPRIS will maintain its competencies, not only as an administrative agency for market access but also leading the policy development in terms of food and supplements. This is something that could be limited; it's not very clear about how things are at the moment, so we are monitoring this very, very closely. Basically, everything which is under the Ministry of Health in Mexico – there is a lot of work to be done and positions to be confirmed.”
The current COFEPRIS commissioner Dr José Alonso Novelo Baeza, for example, handed in his resignation some months ago but it was rejected by Mexican president Andrés Maunal López Obrador, so he remained in office and active. There were also a number of new appointments still being finalized.
Pineda Ereño said these were all “wait and see” cases that would be important for any future decisions made on cannabis use in food and food supplements.