From the category archives:

FDA and Legal Fun

Fish oil

We love fish oils.  Omega 3 fatty acids have some incredibly strong health benefits and we believe everyone can benefit from increasing their intake of Omega 3s.  So, it is very troubling to learn that a number of Omega 3 Fish Oil supplements have been found to have carcinogenic chemicals known as polychlorinated biphenyls, or PCBs.

PCBs, Fish Oil, California… Smells like a Lawsuit!

Yes, last week a lawsuit was filed in California Superior Court in San Francisco.  The lawsuit targets eight supplement manufacturers or distributors – CVS Pharmacy, Rite Aid, General Nutrition Corp., Solgar, Twinlab, Now Health, Omega Protein and Pharmavite – for alleged violations of California’s Proposition 65, which requires that consumers be warned about chemical exposures.

The plaintiffs claim that their initial testing found that levels of PCBs in supplements in popular fish oil products varied wildly, from about 12 nanograms per recommended dose in to more than 850 nanograms.   They claim that Proposition 65 requires disclosure of all non-zero PCB levels, so they are all in violation of the law.

Is this Really a Big Deal?

Yes – in a number of different ways!  First, Omega Protein – named in the lawsuit – is the world’s largest producer of fish oil, so this effects a huge amount of products.  Second, it really brings to the forefront one of the big secrets about the supplement industry – labels do not show exactly what is in the supplement!

You can make the argument that 12 nanograms of PCB is not harmful and the benefits of Omega 3s outweigh the dangers of 12 nanograms of PCB – but this misses the bigger point.  The issue is, should consumers know exactly what they are putting into their body. We firmly believe consumers should know exactly what is in their supplements and then they can make their own choices based on the facts.

Omega Protein Has Many Issues With the Lawsuit

Not surprisingly, Omega Protein disagrees with the allegations in the lawsuit.  You can read their Press Release -

Omega Protein Comments on Lawsuit

There are very valid points about how you test for PCB and exactly what Prop 65 requires.  In addition, a number of independent groups have stepped forward to say that their testing shows that fish oil supplements are completely safe and free of contaminants.

Fish Oil is too important of a supplement to see washed away with a lawsuit.  Our hope is that this lawsuit puts the spotlight on testing and labeling requirements more than on the safety of fish oil.    Anything that makes supplement labels more open and honest is a major step in the right direction.

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What is In Your Supplement?

Millions of people have choosen to use Viagra (the brand name for Sildenafil). It is clear that the whole Erectile Dysfunction (ED) market has become a bonanza for the pharmaceutical companies. What is less clear is that many more of us are using Viagra (sildenafil) without even knowing it!

The Hot New Ingredient for Supplements – Sildenafil!

We first reported last week that a number of acai supplements were causing side effects. An investigation by Health Canada found that these acai supplements were laced with Sildenafil. It is clear that Sildenafil can have serious side effects and anyone using an acai supplement that contains Sildenafil should stop (here is the list of tainted products).

Now we have learned of more supplements that are tainted with Sildenafil. On December 14, 2009, the FDA posted a notice on its website regarding the recall of many sexual enhancement supplements sold by Atlas Operations, Inc. Apparently over 20 Atlas supplements were tested and they all contained Sulfoaildenafil, an analogue of Sildenafil. Of course since Sildenafil is a prescription drug it can not be legally used in supplements, and therefore a full recall was ordered -

Read the FDA Press Release on the Recall

Why Is Everyone Trying to Get Us To Take and ED Drug?

To be honest – we are not sure! We get why Atlas, a company that makes sexual function supplements would try to improve the performance of their supplements by adding Sildenafil. It is incredibly dangerous and irresponsible to spike a supplement with a drug, but at least we can see the motive.

It is a little more of a mystery on why you would spike an Acai supplement with an ED drug. You do feel the effects of Sildenafil, so maybe the idea is to try to get people to think they “feel” the Acai working right away.

Our Advice – Go With Trusted Companies

Some people will look at these stories and claim that they prove that all supplements are dangerous and unregulated. This is not the case. Supplements are regulated, and adding drugs to supplements is clearly not allowed – hence the recall. In any industry you will have dishonest companies – the key is to avoid these companies – not all supplements.

Our advice is to stick with trusted supplement companies that have a proven track record. You want to be able to contact the company with any questions you may have. In addition, do a search at the FDA website to make sure the company does not have any issues.

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Smart Choice LabelIt was fun while it lasted, we all had a good laugh, but now it looks like the concept of calling Froot Loops a Smart Choice has come to an end!

Smart Choices Label Program Has Been Suspended

Guess what? Just days after the Food and Drug Administration (FDA) said it would examine whether front-of-pack nutrition claims are potentially misleading, the fine folks at Smart Choices decided to suspend their label and logo program. Smart Choices has said that it “will voluntarily postpone active operations and not encourage wider use of the logo at this time by either new or currently enrolled companies.”

What Is Smart Choices?

Smart Choices is an industry funded and sponsored labeling program that was supposed to help consumer make better choices about food, based on nutritional content. Kellogg’s, General Mills, Kraft, Unilever, ConAgra, and PepsiCo’s Quaker Foods all took part in the Smart Choices program.
While there were many questionable products that got to display the Smart Choices logo, Froot Loops may have been the one that finally pushed the FDA to investigate. Why isn’t Froot Loops spelt Fruit Loops? Because there is no fruit in there – they had to make up a word because it was a lot better than saying Sugar Loops. Many people were outraged that a ceral filled with sugar could “earn” the Smart Choices logo.

The Secrets are Not Just With Supplements

We spend a good deal of time on this blog giving the supplement industry a hard time for misleading the public (see our countless articles on acai scams and resveratrol scams). It is important to note that deception is not reserved for the supplement industry, here you have some of the largest consumer brands in the world misleading the public into what is a smart choice for breakfast.
Well, I will say they made one Smart Choice – closing the program down.

Additional Rescources:

Article on Suspension of Smart Choices
Smart Choices Program Home Page
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sneeze

Call it H1N1, call it Swine Flu – call it whatever you like but it looks like we are heading for a very bad flu season this year. While there is lots of talk in the media about treatment, vaccines and shortages – there is no shortage of marketing companies trying to prey on your fear!

Swine Flu – Sure We Have A Cure for That!

You know those Apple iPhone commercials that say “We have an app for that” – it feels like some of these marketing companies have the same approach for any disease or illness you may have. The only difference is they replace the word “app” with “cure”. I can just hear them saying – “Swine Flu, sure we have a cure for that”

The FDA and FTC Get Nasty With their Swine Flu Hall of Shame

We have knocked the FDA and FTC in the past for being very slow to shut down the numerous acai scams and the resveratrol scams . So, we now need to give credit, where credit is due. The FDA and FTC are moving quickly to make sure that companies do not take advantage of people’s fears when it comes to H1N1 or Swine Flu. The FDA has sent hundreds of warning letters and even created a searchable, public online database of all the products that have received warnings from the FDA.

Click Here for the FDA Database of Products that may be fraudulently claiming to help with Swine Flu

You see they have them all – gloves, masks, air purifiers, shampoo and of course supplements.
So, before you waste your money on some product that claims to help with swine flu – you might want to do a quick search on the FDA site.

Dr. Andrew Weil caught in the wide FDA Swine Flu Net

[click to continue…]

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Oprah Writes, Then Throws The Book At Acai and Resveratrol Scammers

October 14, 2009

We are so excited, this is like Christmas for us! For over 18 months we have written about Acai scams and Resveratrol Scams. We have explained that Oprah never endorsed any Acai or Resveratrol brands and the same was true with Dr. Oz . People often asked, if the Oprah and [...]

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Read the full article →