Regulatory Focus™ > News Articles > FDA: 'All Natural' Claims Usually Code for 'Fraudulent Product'

FDA: 'All Natural' Claims Usually Code for 'Fraudulent Product'

Posted 04 March 2013 | By Alexander Gaffney, RAC 

Talk to a regulatory professional-any regulatory professional-involved in the regulation of healthcare products in the US, and one thing you're unlikely to hear is an explanation of how simple the entire process is.

Evidence is rarely black and white; treatments, even when amazing, rarely outright cure a patient; claims are nuanced; safety risks are myriad and are often poorly understood for years after being introduced to the public.

And while these sentiments are generally understood by the public and often espoused by US Food and Drug Administration (FDA) regulators, work remains to be done, regulators said in a recent statement.

That's because despite FDA's best efforts, many consumers continue to fall for fraudulent health products and other scams that skirt federal regulations intended to protect the public from harmful products or ones that purport efficacy claims they do not possess.

Warning Signs

Among the health claims you're almost certain never to see approved by FDA: "Miracle Cure, "Revolutionary Scientific Breakthrough" or "Alternative to Drugs or Surgery."

That's according to FDA, which released a statement this week explaining that just because the products are no longer literally labeled as snake oil, that doesn't mean some products aren't effectively the same snake oil products with better marketing.

The problems with these fraudulent products generally fall into one of two areas, said regulators: Either the products contain ingredients that render them unsafe for human consumption, and/or they lack the ingredients necessary to effectively treat a condition, thereby lengthening the amount of time between a person being diagnosed with a problem and seeking effective treatment.

Both have the power to harm consumers, FDA wrote.

But a bigger problem lies in the intersect between what agency regulators have the time and resources to go after and the number of fraudulent products that already exist on the market. Despite FDA's considerable budget, it has a hard time going after every fraudulent product that pops up on the market, usually reserving its enforcement might for products acting egregiously or ones that have gained a considerable amount of market share.

"Health fraud is a pervasive problem, especially when scammers sell online" says Gary Coody, national health fraud coordinator for FDA. It's difficult to track down the responsible parties. When we do find them and tell them their products are illegal, some will shut down their website. Unfortunately, however, these same products may reappear later on a different website, and sometimes may reappear with a different name."

In other words, it's a cat-and-mouse game between fly-by-night operators and a multibillion-dollar agency. And while FDA has been successful in shutting down some of the most egregious violators and pressing charges against some of their operators, a huge number of products remain on the market looking to prey on consumers' hopes and naiveté.

Six Tips for Avoiding Fraudulent Products

That same naiveté is also the focus of FDA's most recent consumer communication, which notes that consumers can almost certainly identify a "rip-off" product using any one of six tricks.

FDA said six claims in particular should raise warning bells for consumers as they are, more likely than not, an indication that the product is a potentially dangerous rip-off:

  1. Any product claiming to be an all-in-one cure for multiple diseases or conditions
  2. Any product relying solely on personal testimonials for claims of efficacy or safety
  3. Any product claiming to treat a condition quickly
  4. Any product claiming to be "all natural"-so are poisonous mushrooms, FDA quipped.
  5. Any product claiming to be a "miracle cure"
  6. Any product claiming to be based on conspiracy theories-the cure "the pharmaceutical industry and the government are working together to hide information about" is just trying to cover for its own insecurities, FDA wrote.

"If a real cure for a serious disease were discovered, it would be widely reported through the media and prescribed by health professionals-not buried in print ads, TV infomercials or on Internet sites," FDA concluded.


Tags: Fraud

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