ANH joins the dots over FDA and FTC restrictions on natural products prior to vaccine roll-out

By the ANH Team


Regulators homing in on immune modulating supplements 

The US Federal Trade Commission (FTC), whose own advertised mission is to "protect America’s consumers", have charged the US pharmacy chain, the Rite Aid Corporation, with "False and Deceptive Advertising" over their marketing claims that their Germ Defense tablets and lozenges "could prevent and treat colds and the flu or reduce the severity and duration of these illnesses". In order to settle the FTC charge, the natural products company has had to agree to pay up to $500,000 in consumer refunds. Rite Aid’s supplier, Improvita Health Products Inc. is facing a similar FTC charge, in an ongoing case. 

The Germ Defense products are marketed as dietary supplements containing vitamins C and E, zinc, and Echinacea. These are natural products being used for the purposes of immune modulation, but the FTC have charged that there is "inadequate evidence" to support their claims that the products "could reduce the risk of or prevent colds and flu; protect against or fight germs; reduce the severity or duration of a cold; protect against colds and flu in crowded places; and boost the immune system".

Lorraine Heller of has noted the current trend amongst regulators, particularly in the US:

"The current case provides additional evidence that FTC – which regulates product advertising – has immunity claims on its enforcement radar, as does the Food and Drug Administration, which regulates product label claims".


US Health Claims: easier to get a camel through the eye of a needle?

It’s becoming increasingly apparent that regulatory approaches to health claims around the world are converging. The health claims environment in the US is increasingly following the same pattern as in Europe, which in turn is mirroring the template being built at an international level through Codex, and specifically, the Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU).

The US Food Drug Administration (FDA) qualified health claims permitted are very limited indeed, and are also subject to "enforcement discretion". It appears that only 16 have passed the extremely exacting FDA requirements as far as evidence is concerned. We reported recently on the US censorship of the scientifically-backed health claims for selenium regarding reduction of prostate cancer risk.

It’s not that much easier to get a health claim accepted in the European Union either, with many surprising rejections by the European Food Safety Authority (EFSA).

Yet there is a wealth of supporting evidence for the immune modulating properties of vitamin C and E, and zinc. Also, well conducted trials with echinacea have shown consistently positive results.

Why are the regulators clamping down and tightening up on the use of natural products for immune modulation, at a time when, with the spread of swine flu, people may want to be strengthening their immune defences?

FDA heavy hitters

While the vaccine makers work to roll out vaccines to large sections of the world’s population in October this year, the US food and drug regulator, the FDA, is stepping up its enforcement procedures to stop dietary supplements being used to support the immune system.

The FDA seems intent on ensuring that absolutely nothing may be marketed to "diagnose, mitigate, prevent, treat, or cure the 2009 H1N1 flu virus" unless it has been cleared by them, and have stated that "unapproved, uncleared, or unauthorized products that claim to diagnose, mitigate, prevent, treat or cure the 2009 H1N1 flu are illegal and a potentially significant threat to the public health".

Click here for a list of products that the FDA have highlighted as uncleared or unauthorised by them for the diagnosis, mitigation, prevention, treatment, or cure of the 2009 H1N1 flu virus (most of these are likely to of course be rather helpful). The FDA have called these products into question as a result of their labeling and marketing. These products remain on the FDA list even after their labeling and marketing wording has been amended to conform to the FDA requirements.

These restrictions amount to a serious limitation on freedom of speech and they run completely contrary to the First Amendment. Americans must surely be horrified to see government agencies carrying this degree of power, circumventing the entire democratic process which has been, for over two centuries, the basis of the country’s existence.


Should we just sit by? 

Are we all to just throw up our hands and submit to the measures approved by the FDA and other regulatory authorities, which are apparently only antiviral drugs and swine flu vaccine? Do people not have a right to know or be educated about natural immune modulating products whose efficacy is backed by science? Are people no longer allowed to take responsibility for their own health? Is our freedom of speech now being massively curtailed? Do people not have the right to informed choice in healthcare? 

It seems, while there are billions of dollars to be made from a pandemic, that our fundamental rights and freedoms can ‘legitimately’ be trampled on. 

Unless of course we choose otherwise. If the murmurings amongst the grassroots are anything to go by, perhaps civil disobedience may well become the order of the day. 


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