by Marion Nestle
Jan 15 2014

The FDA clarifies: Is your drink a supplement or a food?

By an act of Congress, dietary supplements are regulated less strictly than conventional foods, so much so that some beverage manufacturers would much prefer to have their products labeled as dietary supplements than foods, energy shots, for example.

Under the law, the FDA pretty much has to keep hands off of supplements, except when something egregious happens, like people getting sick or dying.

The FDA is now trying to clarify the difference between beverages that are supplements and those that are drugs.  It just issued:

These documents, however, are guidance.  The are not regulations:

This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic.  It does not create or confer any rights for or on any person and does not operate to bind FDA or the public.  You may use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.

Why is FDA doing this?  I’m guessing for two reasons.

1.  The weird ingredients in energy drinks:

We have observed an increase in the marketing of liquid products with a wide array of ingredients and intended uses.  Some of these products are marketed as dietary supplements, and others as conventional foods. 

We have seen a growth in the marketplace of beverages and other conventional foods that contain novel substances, such as added botanical ingredients or their extracts.  Some of these substances have not previously been used in conventional foods and may be unapproved food additives.

2.  The high caffeine levels in those drinks.

Other substances that have been present in the food supply for many years are now being added to beverages and other conventional foods at levels in excess of their traditional use levels, or in new beverages or other conventional foods.  This trend raises questions regarding whether these new uses are unapproved food additive uses.

Caffeine is GRAS (generally recognized as safe) at the levels added to soft drinks.

But the levels in energy drinks are so much higher that the FDA has questions about whether GRAS applies to them.

These guidance documents are open for comment.  If you care about such issues, weigh in now.

Comments

  • charles grashow
  • January 15, 2014
  • 11:43 am

http://www.sciencedaily.com/releases/2013/03/130321205524.htm

Energy Drinks May Increase Blood Pressure, Disturb Heart Rhythm

“Researchers analyzed data from seven previously published
observational and interventional studies to determine how consuming energy drinks might impact heart health.

In the first part of the pooled analysis, the researchers examined the QT interval of 93 people who had just consumed one to three cans of energy drinks. They found that the QT interval was 10 milliseconds longer for those who had consumed the energy drinks. The QT interval describes a segment of the heart’s rhythm on an electrocardiogram; when
prolonged, it can cause serious irregular heartbeats or sudden cardiac death.

“Doctors are generally concerned if patients experience an additional 30 milliseconds in their QT interval from baseline,” said Sachin A. Shah, Pharm.D., lead author and assistant professor at University of thePacific in Stockton, Calif.

“QT prolongation is associated with life-threatening arrhythmias. The finding that energy drinks could prolong the QT, in light of the reports of sudden cardiac death, warrants further investigation.” said Ian Riddock, M.D., a co-author and director of preventive cardiology at the David Grant Medical Center, Travis Air Force Base, Calif.

Researchers also found that the systolic blood pressure, the top number in a blood pressure reading, increased an average of 3.5 points in a pool of 132 participants.

“The correlation between energy drinks and increased systolic blood pressure is convincing and concerning, and more studies are needed to assess the impact on the heart rhythm.” Shah said. “Patients with high blood pressures or long QT syndrome should use caution and judgment before consuming an energy drink.

“Since energy drinks also contain caffeine, people who do not
normally drink much caffeine might have an exaggerated increase in blood pressure.”

The pooled studies included healthy, young patients 18-45 years old. “People with health concerns or those who are older might have more heart-related side effects from energy drinks,” said Shah.”

[…] The FDA clarifies: Is your drink a supplement or a food? […]

If these products are made with GRAS ingredients, then I wouldn’t worry about regulating them. If they injure people, they’ll be sued out of existence.

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  • George
  • January 17, 2014
  • 10:19 pm

What about alcoholic beverages?
In New Zealand these only need to list alcohol content on label. Calories, sugar content, additives (other than sulfites and other potential allergens) are not required by law to be listed (as they are on a soft drink or energy drink, juice or milk package).

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