“DIETARY SUPPLEMENTS IN MEXICO” THE OVERVIEW Norma Leticia Cavazos Guzmán Board Secretariat
“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
WWW.ANAISA.MX
HTTPS://WWW.FACEBOOK.COM/ANAISASUPLEMENTOSALIMENTICIOS
TEL +52 (55) 56151564
MAIL: [email protected]