Congressional ire, in response to some well-publicized dietary supplement abuses, has given the Food and Drug Administration (FDA) the mandate to “clean up the supplement industry.” The newly appointed Commissioner of FDA, Dr. Margaret Hamburg, is accommodating these wishes by building a cadre of supplement industry critics including Ann Witt (formerly of Rep. Waxman’s staff, as was Dr. Joshua Sharfstein, now Dr. Hamburg’s Deputy Director) and, Peter Lurie and Sidney Wolfe, both of whom held positions at the anti-industry “Public Citizen’s Health Research Group” (as did Dr. Sharfstein). These appointments are unmistakable warnings to the supplement industry to get its house in order!
The history of FDA actions on dietary supplements gives some credence to the rumor that early on in the implementation of the Dietary Supplement Health and Education Act (DSHEA), the highest priority was to enforce stringent safety standards for New Dietary Ingredient Notifications (NDIN), but little other action was taken, with the anticipation the industry would implode as the result of reckless behavior by the “bottom feeders.” It appears few resources were committed to policing retail shelves and, as the result of only a few actions taken at the finished product level, many in the industry felt confident that either there was no intent to enforce and/or that there were “gray areas” in regulations – wrong on both counts! FDA was probably not given the resources to look at shelves and the perceived “gray areas” exist only in the imaginations of the naïve and the wishful thinkers – regulations for dietary supplements have few gray areas and dietary supplements are, in fact, more highly regulated than food ingredients!
On October 22, 2009, at the Council for Responsible Nutrition’s (CRN) annual meeting, Dr. Sharfstein indicated that too many supplements were spiked with drugs and/or substances that were not eligible for the grandfather exemption (i.e., marketed as a supplement prior to October 15, 1994). He also indicated that companies (presumably including your competitors) could report violative products to FDA via the reportable food registry. Further, he promised that FDA would use all the tools granted it under DSHEA, including strict enforcement of the 75-day pre-market notification requirement and removal of products from the market that failed to comply.
Since that time, the talk has become tougher. In March, Commissioner Hamburg, writing to Senator Chuck Grassley (R-Iowa) announced FDA plans to “increase the appropriate use of misdemeanor prosecutions … to hold responsible corporate officers accountable” and has developed criteria for selecting cases (“The Tan Sheet” March 8, 2010). FDA has decided that product recall is no longer sufficient punishment for a violative act, but promises to exercise the Responsible Corporate Officer doctrine (also known as the “Park Doctrine”), which has the potential to bring civil and criminal penalties to corporate officers. Despite the fact that the regulations can be Byzantine and interpreted in various ways and there are no guidelines yet published for dietary supplements, you are nonetheless ultimately responsible for compliance. To paraphrase the Commissioner, “it is no longer necessary to prove a person knowingly violated the law, only that he did”[1] (i.e., ignorance of the law is no excuse). Therefore, “unknowingly” violating the act with a contaminated or misbranded supplement can result in short jail terms and large fines, but “knowingly” violating can result in even larger fines and substantive jail terms.
More recently (September 13, 2010), Senator Patrick Leahy (D-VT), has upped the ante with introduction of the Food Safety Accountability Act of 2010 (S. 3767), which “amends the Federal Food, Drug, and Cosmetic Act to impose a fine and/or prison term of up to 10 years for knowingly violating such Act with respect to food that is misbranded or adulterated.” (This draconian action was not a knee-jerk reaction to the Salmonella-contaminated eggs as a similar bill (S. 3669), was introduced by Sen. Leahy in July, months before the contaminated eggs became an issue.) The bottom line – the distribution of an adulterated or misbranded food product, including a dietary supplement, will be a federal criminal offense (Tan Sheet, Sept 20, 2010).
This new era of strict enforcement will cast a wide net and do more than just catch the naïve and the bottom-feeders; it will scoop up all those producers and retailers that may either have not known or “chosen not to know” about the regulations and include them in the category of “those who knew and ignored the law” or those “who should have known”. How ready is your company for the coming crackdown? Burdock Group is ready to help you prepare for the coming onslaught.
Burdock Group is a safety and regulatory consulting firm in Orlando, Florida. We have four PhD toxicologists on board, with near limitless resources in ferreting out information that can prove very useful to you in supporting safety and efficacy claims for your products. We have knowledgeable, on-site and trained full-time employees on staff; we do not use inexperienced subcontractors or part-timers. Your data is safe with us and we can find the answers you need. Our resources include a vast in-house library of information and technicians specifically trained in the science of searching the scientific and public literature. We have access to databases way beyond the free and publicly available National Library of Medicine or Google®, to find the verifiable and documentable references that are needed if FDA comes knocking at your door.
We have experience in vetting manufacturers’ formularies and alerting them to new scientific discoveries that may cast their substance in a negative light or if the substance is not approved (as a supplement) or is not eligible for a grandfather exemption. If a substance similar to yours has been previously notified and are you assuming that the notified substance covers your product as well, let our PhD analytical chemist review the specifications for both and determine if there is “substantial equivalence.” Also, how about your excipients, are they all “safe and suitable”?
When you chose someone to provide support for your product, you need to have the confidence you are well represented. The quality and rigor of the documentation supporting your product and the reputation of those behind the documentation is your best and only defense against a recall, substantive heavy fines and possibly, imprisonment. Burdock Group is the best known in the industry for the quality scientific and regulatory support and your best resource for your product support. Check out our website and our list of publications – we are the most published group in the food and supplement industry – there is no better way to demonstrate credibility.
Contact Burdock Group now and hear about our offers for providing regulatory and scientific support for your products. We review supplements and ingredient lists on a frequent basis (over 180 substances for one company alone), so experience makes our turnaround fast and prices reasonable. Discounts are available for multiple substances.
Contact us today and let us help you get ready for the crackdown.
Reference
[1] Letter to Sen. Charles Grassley, the Tan Sheet, April, 2010.