FDA Warns 14 Companies over Questionable Health Product Claims

FDA Warns 14 Companies over Questionable Health Product Claims

The FDA is warning consumers to avoid 65 products sold online which, according to the agency, come with bogus claims that they can treat, cure, diagnose, or prevent cancer, along with other medical conditions. However, the companies which received the warning were not ordered to stop selling their products. [1]

Referring to the pills, creams, and teas as “a cruel deception,” the FDA says the products are a waste of time and money, and have the potential to harm buyers.

The products in the scope of U.S. regulators are untested and not FDA-approved, and some of them contain natural ingredients that could interact dangerously with prescription drugs. Though it’s important to note that the potential for complications when mixing any ingredients is always a possibility; so it’s never a bad idea to look into that yourself or ask a doctor before mixing any supplements and prescriptions.

Douglas Stearn, director of the FDA’s Office of Enforcement and Import Operations, said:

“Consumers should not use these or similar unproven products because they may be unsafe and could prevent a person from seeking an appropriate and potentially lifesaving cancer diagnosis or treatment.” [2]

Read: Investigation: Many Herbal Supplements Found to Contain ZERO Herbs

On April 25, the agency posted warning letters it sent to 14 manufacturers, informing them that they must remove their “fraudulent” claims describing the products as drugs, or risk harsh fines. [1]

FDA consumer safety officer Nicole Kornspan said in a statement:

“Anyone who suffers from cancer, or know someone who does, understands the fear and desperation that can set in. There could be a great temptation to jump at anything that appears to offer a chance for a cure.”

The FDA’s Real Issue Here are the Claims Being Made

If it seems like the government is trying to crack down on natural health products and practitioners (well, maybe it is…), you should know that the companies which received the warning were not ordered to stop selling their products. Rather, they were told that they cannot make certain claims about their products without any scientific proof to back them up.

Some of the claims the companies make about their treatments include “miraculously kills cancer cells in tumors,” “more effective than chemotherapy,” and “treats all forms of cancer.”

Some of the products are marketed for cats and dogs.

One of the companies, Sunstone, sells a product called Essiac Tea (something we wrote about before, while covering potential positive aspects). The manufacturer says on its website that “cancer and AIDS sufferers or other ill people may wish to take 2 fluid ounces of the tea twice daily on an empty stomach.” Just 8 oz of the drink costs $11. [2]

Read: Researchers Find Unapproved, Untested Stimulant in Several Supplements

For just $34 an ounce, buyers can purchase Sunstone’s Virxcan-X Salve, which is marketed for “liver congestion, arthritis, malignant growths, respiratory and urinary tract infection.”

The company Nature’s Treasures promotes “thermography,” a type of digital infrared thermal imaging that the FDA says is an unapproved device to detect breast cancer. The company claims that thermography “is far more sensitive than mammography.”

Another company said this:

“If a person eats 6-12 apricot kernels per day, they will never have to worry about cancer.” [3]

So, you see, the problem here is the claim that 6-12 apricot kernels prevents cancer. Who tested how many kernels it takes to stave off cancer?

It is illegal to make such claims without proof that the statements are true and going through the FDA’s approval process for verifying them. The agency says companies can’t get away with just putting a tiny disclaimer at the bottom of an ad saying that the FDA hasn’t verified the claims.

Natural Society
Source: NBC News

Stearn and the FDA’s Donald Ashley said:

“Hoping to skirt the law on a technicality, some sellers made false claims and then in small print provided a disclaimer that their products are not intended to diagnose, treat, cure or prevent any disease.

Making such obvious claims and then saying later that you are not doing so might seem clever, but the technique does not comply with federal laws intended to protect public health.”

What’s Next

The FDA gave the companies 15 days to correct the violations or submit a plan for how they plant to correct them. The easiest way for the companies to comply is to simply remove the ‘deceptive language’ from their websites. [2]

If the companies fail to comply, the agency will take further action that could include court injunctions on the sale of their products.

The FDA said:

“The message to consumers is this: These products are untested. Some contain ingredients that may be a direct risk to your health.

The ingredients may interact in a dangerous way with professionally-prescribed treatments. They are not a substitute for appropriate treatments. Using these products can waste your money, and, more importantly, endanger your health.”

Is the FDA striking down on natural health products, as some might say? That is indeed a possibility, but one main takeaway I’d like to point out is to always exercise due diligence when buying a product – especially if it’s for a serious condition. Whether the products work or don’t work, the reality is that you need to take into account all of the information available before making your decision on whether or not to purchase and rely on such products.


[1] The Associated Press

[2] The Washington Post

[3] NBC News

Images Source:

NBC News