Food Structure
What is it?
Follow along with me:
Which of the following claims can appear on a food or supplement
label without approval from the Food and Drug Administration?
a. Improves memory
b. Relieves stress
c. Suppresses appetite
d. Helps reduce difficulty in falling asleep
e. Supports the immune system
The answers: A, B, C and E. These are called structure/function
claims. They describe how a food or supplement affects the
body's structure (i.e., the skeleton) or its function (i.e.,
digestion). Manufacturers can place one on virtually any food
or supplement with or without evidence to back it up.
Until recently, structure/function claims showed up only
on supplements. However, in 1994, under strong industry pressure,
Congress passed the Dietary Supplement Health and Education
Act. The law gives supplement-makers free rein to make structure/function
claims, as long as the companies following these guidelines:
1. Notify the FDA within 30 days after using a new claim
2. Print the following disclaimer on the label: These statements
have not been evaluated by the Food and Drug Administration.
This product is not intended to diagnose, treat, cure or prevent
any disease.
In January, 2000, the FDA tried to answer the question, "Which
claims need FDA approval and which do not?"
Claims Requiring FDA Approval:
1. Lowers cholesterol
2. Maintains healthy lung function in smokers
3. Provides relief of chronic constipation
4. Suppresses appetite to treat obesity
5. Supports the body's anti-viral capabilities
6. Relief of persistent heartburn or acid indigestion
7. Helps reduce difficulty in falling asleep
8. Helps restore sexual vigor, potency and performance
Claims That Do Not Require
Approval:
1. Helps maintain normal cholesterol levels
2. Maintains healthy lung function
3. Provides relief of occasional constipation
4. Suppresses appetite to aid weight loss
5. Supports the immune system
6. Relief of occasional heartburn or acid indigestion
7. For relief of occasional sleeplessness
8. Arouses sexual desire
9. Improves memory
10. Improves strength
11. Promote digestion
12. Boosts stamina
13. For common symptoms of PMS
14. For hot flashes
15. Helps you relax
16. Helps enhance muscle tone or size
17. Relieves stress
18. Helps promote urinary tract health
19. Maintains intestinal flora
20. For hair loss associated with aging
21. Prevents wrinkles
22. For relief of muscle pain after exercise
23. To treat or prevent nocturnal leg muscle cramps
As you can see, there is a very fine line between the approved
claims and non-approved claims. The distinction between a
structure/function claim and a disease claim can be subtle.
For example, "Relief of persistent heartburn or acid
indigestion" is a disease claim that falls under FDA
approval. In contrast, "Relief of occasional heartburn
or acid indigestion" is a structure/function claim requiring
no FDA approval. You see how fine that line is?
For supplements, the FDA sees to it that there is no claim
made regarding a disease. For example, there are claims that
can only pertain to drugs that treat diseases. According to
the current laws, a disease claim promises to "diagnose,
cure, mitigate, treat or prevent disease." If a supplement
makes a disease claim, the supplement legally becomes a drug
- drugs must be pre-approved for safety and effectiveness.
The result: An illegal supplement. The situation we now find
ourselves in is that food companies need not bother with health
claims when they can say just about anything they want by
using structure/function claims. The result? The supplement
industry makes a fortune using structure/function claims.
You, the consumer, are getting ripped off. Another result
pertains to the food industry - they now have a free ride
with structure/function claims as well. Food companies do
not have to notify the FDA or print a disclaimer, like supplement
companies do. Consequently, structure/function claims are
starting to show up all over the marketplace. So far, many
are showing up on decent foods, like fruit juice and fruit
but it is only a matter of time before they start to pop up
in the junk food sections and soft-drink aisles.
How to Tell One Claim
From Another
1. Solid Health Claims. These reliable claims - based on solid
evidence - name a disease like cancer, stroke, or heart disease;
usually refer to a "diet" that is low (or high)
in some nutrient; and cannot appear on unhealthy or empty-calorie
foods.
2. Preliminary Health Claims. These unreliable claims are
based on incomplete evidence. They have a disclaimer that
ranges from the cautious ("the FDA has determined that
this evidence is limited and not conclusive") to the
silly ("the FDA concludes that there is little scientific
evidence supporting this claim").
3. Structure/Function Claim. These unreliable claims require
no approval - in practice, that may mean no evidence. Instead
or diseases, look for words like "maintains," "supports",
and "enhances" and euphemisms (like "optimizes
bone health"). They can appear on any food. |