Respuestas a comentarios de la NOM 141

Conforme quedaron estos comentarios, lo que yo veo es que:

1.       Todos los apartados que se trabajaron indicando que los ingredientes no se tendrían que traducir al Español desaparecieron del proyecto. Por un lado la Ley general de Salud y el Reglamento de productos y servicios si permiten los ingredientes en otro idioma por la parte de Salud. Por otro la Ley Federal de Protecciòn al Consumidor indica que toda la información al consumidor debe estar en Español, sin exentar los ingredientes. PROFECO sí puede revisar los ingredientes. no recomiendo dejar de poner los ingredientes en Español hasta tener un definición de parte de la autoridad de Economía. 

2.        Se pide una fecha de caducidad o vencimiento.  En el documento original sólo en productos  con no más de 2 años de vida de anaquel y que puedan contaminarse con facilidad. Aquí nunca se consideró que los productos como polvos faciales y labiales fueran a requerir  la caducidad o vencimiento ya que son productos que en efecto duran bastante más de 2 años. Sin embargo en el comentario me dicen lo contrario.

3.       Se exige que los bloqueadores solares cuya función principal sea proteger de la luz UV comprueben el FPS que indican en la etiqueta y se enlistan los métodos de prueba que se van a aceptar.  Esto significa que a los bloqueadores solares se les tiene que MEDIR el FPS. Los cuadros de ingredientes y porcentajes y los cálculos y aproximados no valen. Es hacer el estudio conforme a las normas indicadas.

4.       Desaparece el nombre especìfico quedando solo el genérico como obligatorio.  Por supuesto si además del genérico también se usa un específico, mientras no se entienda como una declaración de propiedades medicinales no hay problema de dejarlo.

5.       Se incluye una lista de denominaciones genéricas para los cosméticos que se indica como no cerrada en la lista pero en donde se indica el uso del genérico se indica que debe venir de ella.

6.       Se vuelve a incluir la excepción de no usar las leyendas de “contenido”, “contenido neto”; o cualquiera de sus abreviaturas en la declaración de contenido de los cosméticos.

7.       La norma entrarà en vigor a los 90 dìas de su publicación.  Y hay un año más para agotar existencias o reetiquetar los productos que lo requieran.

respuesta a comentarios agosto 2012

Criterios de verificaciòn PROFECO

PROFECO publicò en el DOF los criterios a aplicar cuando realizan verificaciones a publicidad e informaciòn de productos.

Estos criterios funcionan para saber què es lo que NO se debe hacer en cualquiera de los elementos que dan informaciòn sobre un producto como puede ser su descripciòn y atribuciones en una etiqueta o el material publicitario, sin importar a travès de que medio se difunda.

criterios profeco 2012

Overview of regulation requirements for food supplements and herbal products in Mexico

  

Very recently the health authorities in Mexico have taken strong actions against products that are commonly known as “Miracle Products”. The term refers to those products that claim NOT to be medicines or medical devices in order to avoid having to prove their efficacy and therefore not obtaining a registration number; which a is legal requirement for products that claim to cure or prevent or cure any disease or its symptoms.
Many of these products are masquerading as “food supplements”; and are equivalent to what is known in other countries as “Herbal supplements”; or are just multivitamins.  Others try to pass off as cosmetics and offer medicinal actions (such as reducing dress sizes),  which is not allowed for cosmetic products. Some of these argue they are “Health” products.
The current regulations in Mexico do not consider a category for “health” products”, “herbal products” or for “natural products”. Regulations basically consider two categories:
1. Products for general consumer use (foods, beverages, cosmetics, food supplements, amongst others)
2. Products to be used under medical supervision/advice/prescription (medication/drugs, herbal remedies, medical devices)
The basic differences between both categories are:
• General products are not registered, they are notified and depending on the sanitary risk for each product any specific category may have further requirements.
• All the other products DO REQUIRE registration by the sanitary authorities before they are labeled, imported, advertised, or put on sale.
Regarding some specific natural or health products and the classification they usually go into according to Mexico:
1.    Food supplements are products that are a subcategory within food; they are notified and require no registration. Food supplements must comply with the following:
a. The formulas and claims must be in accordance to the legal definition for the product: they must supply basic nutrients (protein, fats, carbohydrates) and may or not also contain vitamins and minerals, but cannot consist only of vitamins and/or minerals. Food supplements cannot alter metabolism, prevent/cure/treat or intervene in any way with disease/symptoms. They cannot be weight loss aids/products/etc.
b. Labeling must be done in accordance with Mexican regulations. Translation of English labels into Spanish is not adequate.
c. For import a prior import permit from the health authorities is required PER SHIPMENT.
2. All herbal products that have no nutritional value usually go into either the herbal medication category or the herbal remedy category. Both of these are categories requiring prior registration of the product.
a. Herbal medications are products based exclusively on herbs that have a known and standardized pharmacological active. As these are drugs, there must be proper clinical trials demonstrating the effectiveness of the drug contained. Their sale is restricted to drugstores, but they may or may not require a prescription, depending on the drug they contain.
b. Herbal remedies are products based exclusively on plants that have a traditional usage as treating symptoms, but for which there is no identified active drug in the herbs contained. They ALSO require registration, and are sold as OTC are sold in the US. Owner of the registration must be a manufacturing lab established within Mexico.
3. Homeopathic products (tinctures, for example) are classified as homeopathic medication in Mexico. They are considered as containing drugs (Pharmacologically active compunds), and must be registered and also must have the studies demonstrating the dinamization will provide the active ingredient required.
In order to avoid the problems derived from denied import permits or from product recalls from the authorities, we strongly suggest that before any new product is imported into Mexico or manufactured in Mexico, the legal requirements and correct classification are reviewed in order to make sure the product will be within the legal requirements.