*GG*
senior member
- Messages
- 6,389
- Location
- Concord, NH
The study itself is remarkable for the number of flaws in its methodology and analysis:
http://www.anh-usa.org/gov-report-justify-fda/
- They sampled only 119 supplements out of 90,000 supplements on the market. Why? Because they chose to sample weight loss supplements and supplements for immune support. The researchers knew that weight loss supplements are usually the worst offenders, are certainly not representative of the nutritional supplement industry as a whole, and this intentionally skews the results.
- Companies had to voluntarily submit whatever substantiation they had for their claims (66 of 104 companies did so), which again is hardly representative of the substantiation available for all supplement structure/function claims.
- Not surprisingly, FDA could not readily determine whether manufacturers had submitted the required notification for their claims. FDA could only locate 21 of the 127 notification letters. This points to serious disorganization within the FDA, which calls into question whether FDA even has the capacity for greater enforcement.
- The report says that 7% of the supplements reviewed lacked the required disclaimer, and 20% included prohibited disease claims on their labels. These instances, the report says, raise questions about “the extent to which these structure/function claims are truthful and not misleading.” We would point out that it was 7% of the 127 they selected, which means that only nine supplements lacked the required disclaimer. And not having a disclaimer doesn’t mean the information provided in the structure/function claims are not truthful or are in any way misleading! Moreover, disease claims for supplements are illegal, and FDA already has authority to enforce against them. If companies are making disease claims, they are certainly violating the law—although they are not necessarily being either misleading or untruthful.
http://www.anh-usa.org/gov-report-justify-fda/