“DIETARY SUPPLEMENTS IN MEXICO”

THE OVERVIEW

Norma Leticia Cavazos Guzmán

Board Secretariat

SCOPE

Dietary Supplements

- What’s a Dietary/Food Supplement?

- What’ a Dietary/Food Supplement IS NOT?

- Definition and its challenges

Ingredients: What is allowed and what is not allowed in Dietary Supplements

- Regulatory framework

- Ingredients allowed and not allowed

- Updates on additives and botanicals agreements

Advertising for Dietary Supplements: Legislation framework

- From the General Health Law (Food Umbrella)

- Dietary Supplement must not

- ANAISA- COFEPRIS Ethic agreement

ANAISA´s participation at Mexican Congress

DIETARY SUPPLEMENTS

WHAT’S A DIETARY/FOOD

SUPPLEMENT?

In Mexico, Dietary Supplements are allowed to contain:

plants

vegetable extracts,

traditional foods,

dried and concentrated fruits,

with or without added vitamins and minerals

Presentation: Pharmaceutical form

Intend of use:

“… used to increase the total diet ingestion, complement it, or provide some

components not included in the diet…”

(Art. 215, General Health Law. Mexico)

WHAT’ A DIETARY/FOOD

SUPPLEMENT IS NOT?…

Drugs or medicines

weight loss products

Products changing or improving physical body’s appearance

Replacement of a healthy eating (well balanced and proper diet)

Prevent or cure any disease or symptom

DEFINITION AND ITS CHALLENGES

Dietary Supplements are not allowed to claim functional benefits

“ …Be promoted with ingredients enhancing product’s physiological or functional

benefits...”

Examples

• fiber to improve digestion;

• Calcium helps bone growth;

• Echinacea to improve immunologic

system

INGREDIENTS: WHAT IS ALLOWED AND WHAT

IS NOT ALLOWED IN DIETARY SUPPLEMENTS

REGULATORY FRAMEWORK

Products and Services’ Regulation

Botanical Agreement

Additives Agreement

Herbal Pharmacopeia

National Standard for GMP´s (NOM-251-SSA1-2009, Prácticas de higiene

para el proceso de alimentos, bebidas o suplementos alimenticios)

INGREDIENTS ALLOWED

Carbohydrates

Proteins

Aminoacids

Lipids

Plant Material

Additives

Metabolites

Algae

(Art. 168, Products and Services Regulation)

INGREDIENTS NOT ALLOWED

Therapeutic substances with pharma benefits .

Procaine, ephedrine, yohimbin, germanium,

Animal or human hormones.

Banned plant material on the teas’ chapter.

Toxic plants known by Mexican Pharmacopeia.

(Art. 169, Products and Services Regulation)

UPDATES: ADDITIVES AGREEMENT

The document is divided by categories (e.g. bread, dietary supplements, color).

Additives listed there can be used specifically in that category

It is open to updates twice a year.

Adding an additive could go through 2 ways:

Fast track

Slow track

- Codex

- FDA

- EU

- Time: 2- 4 weeks

Dossier including

toxicity studies

Time: months,

years

UPDATES:

BOTANICAL AGREEMENT

Last publication was in 1999.

This agreement includes 3 lists:

- Plants not allowed to be used in tea and dietary supplements

- Plants approved to be used in tea with a caution legend

- Plants approved as vegetable oil sources.

UPDATES:

BOTANICAL AGREEMENT

This agreement is currently open by COFEPRIS for an update.

New agreement structure:

1. Approved plants as vegetable oil sources.

2. Not allowed plants to be used in teas.

3. Plants approved to be used in teas with cautionary legend

4. Allowed plants to be used in dietary supplements (vegetables and fruits in general).

5. Not allowed plants to be used in dietary supplements (e.g. Echinaccea, Ginseng, Ginko

Biloba, Saw Palmetto, Psyllium, others)

UPDATES:

BOTANICAL AGREEMENT

AUTHORITY CONSIDERATIONS

1. Mexican definition for Dietary Supplement

“… used to increase the total diet ingestion, complement it, or provide some

components not included in the diet…”

2. Dietary Supplements are not allowed to contain:

Therapeutic substances with pharma benefits

Procaine, ephedrine, yohimbin, germanium,

Animal or human hormones.

Not allowed plants for tea.

Toxic plants known by Mexican Pharmacopeia.

3. Other regulations

CODEX

EU

CHILE

ARGENTINA

COLOMBIA

CANADA

USA

Dietary Supplement’s definitions in these

legislations includes :

Nutrients source

Physiological effects

And Nutritional effects

UPDATES:

BOTANICAL AGREEMENT

AUTHORITY CONSIDERATIONS

COFEPRIS CRITERIA

• It is not possible to include plants with therapeutical

and/or pharmaceutical benefits.

• COFEPRIS only accepts plants with nutritional

benefits.

THEN, LAST DRAFT INCLUDED…

206 botanical to be used on dietary supplements, based on :

“significant” nutrient content Final consumer’s safety

NO therapeutic or pharmacological benefits

reported by WHO, Scientific sources or PHARMACOPEA

BUT …

“… If the botanical ingredient is allowed as an additive, then industry

could use it under the levels accepted on the Additives Agreement

even when it isn´t allowed to be used on a Dietary Supplement as

ingredient…

… And, it must be advertised and claimed as ADDITIVE…”

WHAT CAN WE DO TO ADD A PLANT TO THE

POSSITIVE LIST OF THE AGREEMENT?

COFEPRIS PROPOSED A

PROCEDURE PRESENTING

A DOSSIER INCLUDING:

Scientific name

Synonymous

Common names

Chemical composition

Technological uses

Toxicity

Counter indications

Adverse reactions reported

Cautionary legends

Interactions with food, drugs, plants, etc.

Bibliography

INDUSTRY CHALLENGES

It applies for all plants (fruits, vegetables and other botanics)

COFEPRIS does not provide the legal time to evaluate the complete dossier and

the final answer.

Even when the plant is allowed on the agreement it is necessary to ask to

COFEPRIS if the product could be a Dietary Supplement.

ADVERTISING FOR DIETARY SUPPLEMENTS:

LEGISLATION FRAMEWORK

FROM GENERAL HEALTH

LAW (FOOD UMBRELLA)

Dietary Supplements must not:

Promote non acceptable healthy habits

Declare that product cover all nutritional requirements per se.

Give to processed food attributes over their natural composition

Indicate dietary supplement over natural food .

Promote supplements to cure, prevent or treat any disease or symptom

DIETARY SUPPLEMENTS

MUST NOT:

Suggest through fiction or real characters that these products can provide

extraordinary abilities or characteristics.

Promote the consumption of alcohol, tobacco and illegal drugs.

Claim not scientifically proven benefits

Claim these products are intend/help to treat/cure/decrease illness or

physiological conditions.

ANAISA –COFEPRIS

ETHIC AGREEMENT

Signed in February, 2013.

All ANAISA members are committed with this agreement.

National authority benefits to ANAISA are as follow:

Training

Shorter time for approval (5 days instead of 20)

ANAISA as a reference to others

One to one communication

ANAISA´S PARTICIPATION AT

MEXICAN CONGRESS

A new definition that

includes

physiological

effects.

Main legislators searching and socialize the topics

Proposal from Legislators Chamber

House of Representatives

Commission studies

Legislators Chamber

CURRENT MEMBERSHIP

ANGÉLICA FUENTES- OMNILIFE - President

OCTAVIO MORENO- HERBALIFE Vicepresident

JULIO CÉSAR TREJO- USANA - Treasurer

NORMA LETICIA CAVAZOS- AMWAY - Secretary

JUAN ERNESTO BÁRCENA– DSM – Counselor

MERCEDES SÁNCHEZ - CMD - Counselor

BOARD

THANK YOU

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MAIL: GERENCIA@ANAISA.MX