FDA Enforcement Letter Indicates Our Freedom to Choose has been Further Eroded

Last summer I wrote a blog post about small natural health companies needing to exercise caution with social media because of how normal interaction between company and customer, can be viewed as a medical “intended use” for your product.

Regretfully not everyone is privy to the latest tactics of the FDA and their international counterparts. In a warning letter to a manufacturer of a natural cough syrup, the FDA revealed the following:

·   Positive health-related comments from customers are considered intended use claims. (Cure, mitigation, treatment, or prevention of disease)

·  When the company “likes” a customer comment, it is further evidence of the product being a drug or device.

·  The company’s website may be free of any claims, but if the company’s social media is linked to the company website, and any of the social media sites contain the above two points, it is considered the same as making the “claims” on your own website and more evidence that will be used by the FDA.

Here is the link to the FDA letter. It would be a good idea to read it carefully: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm403255.htm

You can see how sophisticated and efficient the FDA has become in their research. The letter illustrates that they did a careful analysis of each Twitter post, each Facebook post, how they linked, a website review, and more.

 

Some people, including myself, would say that although we may be frustrated with the inefficiency of bureaucracy, it is exactly that inefficiency that helps keep our freedoms. The FDA, in this case, is sadly becoming more efficient.

 

Regulatory bodies have surpassed any recognizable common sense in how they view the world. In this particular case its analysis cites that this natural cough syrup is

 

“offered for conditions that are not amenable (coughs) to self-diagnosis and treatment by individuals who are not medical practitioners; therefore adequate directions for use cannot be written (for coughs) so that a layperson can use these drugs safely for their intended purposes.”

 

It is sad that we have created such a politically compromised - and in some cases - a corrupt machine as the FDA (and their international counterparts).

To stay safe through these crazy times, I’ll repeat what I said in a previous post:

1. Let word-of-mouth advertising do the job. You may not grow as big or as fast, but you will still be around to serve those customers that believe in your product, your right to sell it, and their right to buy it.

2. Be scrupulously honest and do not dramatically market your product.

3. Be mindful of the politics and new regulations.

4. Support each other by sharing information and looking out for each other.

5. Help educate consumers on the issues surrounding health freedom.