Regulatory Focus™ > News Articles > Separate OIG Reports Uncover Systemic Problems With Regulation of Supplement Industry

Separate OIG Reports Uncover Systemic Problems With Regulation of Supplement Industry

Posted 03 October 2012 | By Alexander Gaffney, RAC 

Two new reports released by the US Department of Health and Human Services' (DHHS) Office of the Inspector General (OIG) call for additional oversight over the dietary supplement industry, with government investigators chiding the industry for routinely flouting federal requirements and being difficult to track.

That supplement companies routinely run afoul of US Food and Drug Administration (FDA) regulation should be of no surprise to its regulators. Its officials, including its director of the Division of Dietary Supplement Programs, Daniel Fabricant, have this year said that they are "aghast" at the industry's lack of current Good Manufacturing Practice (cGMP) adherence and adverse event reporting compliance. FDA has spent much of this year increasing the number of warning letters sent to dietary supplement manufacturers for basic cGMP infractions and safety issues, including 10 sent in April 2012 to distributors of the supplement dimethylamylamine (DMAA) over safety concerns.

OIG's assessment of the supplement industry may be far more damning than Fabricant's, however. Its investigators looked at the structure and function claims of a sample of 127 dietary supplements marketed as being able to help patients lose weight or support their immune system. Such claims operate in a sort of loophole space in FDA regulations. Because any product claiming to prevent or cure a disease would automatically be categorized as a drug, dietary supplement manufacturers instead claim that their products support certain bodily functions. So, for example, a dietary supplement could not say that it prevents osteoporosis, but could claim that it contains calcium which, when taken in proper amounts over a patient's lifetime, may reduce the risk of getting osteoporosis.

OIG's assessment of the supplements included their claims, substantiation of the claims with quality evidence and the accuracy and completeness of notification letters sent to FDA to back up their claims.

Substantiation of Claims Practically Nonexistent

The agency said most claims were not made in compliance with FDA guidance and regulations.

"Overall, substantiation documents for the sampled supplements were inconsistent with FDA guidance on competent and reliable scientific evidence. Seven percent of the supplements lacked the required disclaimer, and 20 percent included prohibited disease claims on their labels.  These results raise questions about the extent to which structure/function claims are truthful and not misleading."

The evidence behind the supplement claims was perhaps most alarming of all, said OIG. "Of the 34% of substantiation documents that were human studies, none met all of FDA's recommendations for competent and reliable evidence." Those basic standards involve the relationship of evidence to the claim being supported, the totality of the evidence, the quality of the evidence and the meaning of the claim.

Even more surprising: Only 2% of products supported by human studies actually studied the product in question. The rest relied on other studies involving ingredients contained within the product, but not the product itself. OIG noted that other studies studying the same active ingredient usually involved different forms, doses and potencies.

OIG also observed a significant number of other problems, such as 85% of studies that lacked basic experimental controls such as randomization, double-blinding, control groups and parallel groups.

OIG said FDA was unable to determine which manufacturers had submitted evidence of their claims to the agency and which had not, and recommended the agency seek new authorities to review structure/functions claims and create a more organized system to review and track them. Additional marketed surveillance efforts should also be conducted to ensure compliance, said OIG.

FDA said it agreed with the latter two recommendations but would not be seeking additional and explicit statutory authority to review evidence for structure and function claims.

FDA's Food Facility Registry Rife with Problems

In a separate study, OIG officials said they were also concerned about FDA's ability to track down specific manufacturing facilities in the event of a public emergency, such as a bioterror event.

Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, FDA is supposed to populate a Food Facility Registry with information to contact companies in the event of a public health emergency. OIG noted its concern with the quality and effectiveness of the registry in previous reports, but said recent events related to simple adverse events show the database is in dire need of an update.

In the course of its investigation, OIG looked at a random sampling of 127 supplements. Of those 127, 123 were made by companies registered with FDA, and should have been populated in FDA's database. After OIG conducted interviews with each of the companies, it determined that 28% of companies maintained facilities that were unregistered with FDA. Of the 72% that did register, nearly three-quarters of the companies supplied incorrect or incomplete information.

OIG also found that 20% of all supplement labels failed to include contact information for consumers to report adverse events, potentially complicating response coordination in the event of an emergency.

In a response to OIG, FDA said it is working to improve the accuracy of the registry and is seeking new authority from Congress to impose civil penalties against noncompliant companies.


Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe