Transcript Future Health Foods

Regulation of Food & Dietary
Supplements
Janet McDonald, Ph.D., R.D.
Today’s Topics
• Introduction to the legal
authority
• General requirements for food
and dietary supplements
• Structure/function claims
• Boundaries
FDA’s Legal Authority
• Federal Food, Drug, and
Cosmetic Act
• Fair Packaging and Labeling
Act
Dietary Supplements
• Nutrition Labeling and Education
Act (NLEA)
• Dietary Supplement Health and
Education Act (DSHEA)
Interpretation of the Statute
•
•
•
•
Code of Federal Regulations
Guidance documents
Case law
Informal guidance
What is Food ?
“...articles used for food or drink for
man…chewing gum…and articles
used for components of...” food or
drink or chewing gum
What is a food additive?
• Broad sense: Any substance added to
food.
• Legally: “Any substance the intended use
of which results or may reasonably be
expected to result- directly or indirectly in its becoming a component or otherwise
affecting the characteristics of any food.”
– Direct additives
– Indirect additives
What is GRAS?
• Substances whose use is generally
recognized as safe, based on their
extensive history of use in food before
1958, or based on published scientific
evidence.
• Not set in concrete!
What is a Drug ?
“…article intended for use in the
diagnosis, cure, mitigation,
treatment, or prevention of
disease…”
What is a dietary supplement ?
“…a product (other than tobacco)
intended to supplement the diet
that bears or contains one or
more” designated ingredients
What is a dietary supplement ?
• Vitamin, mineral, amino acid
• Herb or other botanical
• Dietary substance for use by man
to supplement the diet by
increasing the total dietary intake
What is a dietary supplement ?
• Concentrate, metabolite,
constituent, or combination of
the ingredients above
What is a dietary supplement ?
• Intended for ingestion
• Pill, capsule, liquid, powder, “other”
• Not represented for use as
conventional food
• Not sole item of meal or diet
• Labeled as a dietary supplement
Messages…..
• Definitions and Regulatory “Boxes”
• ….And that they matter
• What to “think about” at this evolving point
Boundaries
Food
Dietary Supplement
Drug
Which Regulatory Box Is
Important Because…..
• Different legal requirements
• Different safety considerations
• Different substantiation for claims
Dietary Supplement or Food ?
Dietary Supplement or Food ?
Food
Dietary Supplement
Represented for use as conventional food
•Safe ingredients
•Claims
•Labeling
What is “Functional Food?”
It is undefined but regulated
as food
“Functional Food?”
“Functional Food?”
“Functional Food” Claims
Structure/function claims
Truthful
Non-misleading
Based on nutritive value
No drug claims
“Functional Food” Claims
Disease claims - Drug
• Dietary support during the
cold and flu season
• Prevents the onset of disease
complications
Dietary Supplement
Drug
Structure/function claims
• 30-day post-market notification for structure/
function claim
• Use of “disclaimer”
• Manufacturer is responsible for substantiation
30-Day Notification
Disease claims - Drug
• Reduces cholesterol
• Reduces fever
• Helps promote normal body function
after taking too much drink
30-Day Notification
Structure/function claim
• Gingko biloba promotes healthy brain
function
• Guar gum promotes healthy intestinal function
• Helps maintain cholesterol levels in normal
range
The Key to Almost Everything
Is……….
Intended Use
(claims)
Intended Use Gets You into Two
Possible Boxes…. initially
Functional Food
?
Foods
Drugs
Conv Foods
Dietary
Supplements
Prescription
OTC
More on This Perspective
• Functional Foods
-------> Assumption: probably about foods
• Dietary supplements are intended to
supplement the diet
What’s the Difference?
• Conv Foods versus Dietary Supplements
– Safety Standard
• Conv Food: GRAS/Food Additive
• Dietary Supplm: Signif-Unreasonable Risk
– Claim topic / substantiation
• Disease endpoint / Same: Rigorous--Pre-review
• Non-disease endpoint / Essentially Same*
=Truthful/Not Misleading
*What’s the Difference?
• Nutritive Value / Food-Like Effect
– Characterizes oversight of conv food claims
– Not well defined or articulated
– DSHEA specifies that dietary supplements do
not have to have nutritive effect
– Point of resolution:
• NV Needed? Drug versus Food?
• What does it mean scientifically today?
More on This Perspective
• Do Functional Foods need their own
regulatory box?
– Probably not
• Do they need some special considerations?
– Probably yes
Food - Dietary Supplement - Drug
• Chewing Gum
• Breakfast cereal type products
• Product in bar form
• Bottled water
FOR MORE INFORMATION
• Check out FDA’s web site
– www.fda.gov
– Foods
• Food labeling
• Dietary supplements