Functional foods are on target to be hotter than ever. The function food industry has been growing steadily with a projected growth rate of 56 percent since 2011.
What Will You Read Here?
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:
- Notify the FDA within 30 days after using a new claim
- 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:
- Lowers cholesterol.
- Maintains healthy lung function in smokers.
- Provides relief of chronic constipation.
- Suppresses appetite to treat obesity.
- Supports the body’s anti-viral capabilities.
- Relief of persistent heartburn or acid indigestion.
- Helps reduce difficulty in falling asleep.
- Helps restore sexual vigor, potency and performance.
Claims That Do Not Require Approval:
- Helps maintain normal cholesterol levels.
- Maintains healthy lung function.
- Provides relief of occasional constipation.
- Suppresses appetite to aid weight loss.
- Supports the immune system.
- Relief of occasional heartburn or acid indigestion.
- For relief of occasional sleeplessness.
- Arouses sexual desire.
- Improves memory.
- Improves strength.
- Promote digestion.
- Boosts stamina.
- For common symptoms of PMS.
- For hot flashes.
- Helps you relax.
- Helps enhance muscle tone or size.
- Relieves stress.
- Helps promote urinary tract health.
- Maintains intestinal flora.
- For hair loss associated with aging.
- Prevents wrinkles.
- For relief of muscle pain after exercise.
- 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 food structure and food function 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 food structure and food 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.
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, food structure and food 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.
Did You Know?
FOSHU is the Japanese term for functional foods. It stands for “Foods for Specified Health Use i.e., processed foods containing ingredients that aid specific bodily functions, as well as being nutritious.