Janet McDonald, Ph.D., R.D.

Regulation of Food & Dietary Supplements

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

Dietary Supplement ComplianceBoundaries

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

DrugsPrescription

OTC

Foods

Conv Foods Dietary

Supplements

?

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