Regulatory Enforcement is Here

For years, the dietary supplement industry complained that FDA was not enforcing the law, and rightly so. Those days are over, and aggressive FDA enforcement is upon us. This will have a profound effect on the entire value chain of our industry. Those companies that have invested in science, quality assurance, supply chain management and auditing, information technology, claims substantiation, and employee training will be positioned to capture market share and avoid costly compliance issues. Those who have not invested in these areas will face big (and potentially insurmountable) challenges. This applies to growers, processors, suppliers, manufacturers, distributors and retailers.

First, here is some background in case you were not involved in the industry 20ish years ago. Prior to 1994, there was no such thing as a "dietary supplement." There were tablets, capsules, powders and liquids that consisted of vitamins, minerals, herbs and other ingredients, but these products were by law either foods or drugs, and that determination was made based on the product's conditions of use (labeling, claims, etc). FDA would routinely take enforcement action against "supplements" by classifying them as either unapproved drugs (because of claims) or unapproved food additives (because of ingredients not GRAS or pre-approved as food additives). Following years of grassroots and industry efforts, the Dietary Supplement Health and Education Act (DSHEA) was passed and signed into law in December 1994. This created a regulatory framework for dietary supplements as a subset of foods. This law was industry's doing, and it was celebrated as a major victory for consumer access to supplements and information about them.

In addition to the new tools it provided to industry (regulatory definition, structure-function claims, use of third-party literature, etc), it also established important responsibilities for both industry and FDA to ensure quality, safety and efficacy of the products. Both industry and FDA fell short in these areas of responsibility. It took FDA too many years to come out with the GMPs, and the agency essentially let supplement marketers run wild with little threat of agency scrutiny or enforcement. Industry failed to practice self control or develop effective systems to address the "bad actors" that became far too common. Competitive pressures on price led many companies to cut corners, put blinders on, or blatantly adulterate ingredients and products for economic gain. We see the impact of this today when not a week goes by without an announcement of a recall of adulterated products.

The days of FDA apathy are over. The agency, in collaboration with our associations and responsible corporate citizens, is taking on the adulteration issue and those involved. Look for even more inspections, investigations, recalls, warning letters, and criminal prosecutions. Here are some recent examples related to adulterated products:

Prolatis warning letter, Dec. 2, 2010

Natural Wellness warning letter, Oct. 5, 2010

The FDA is conducting GMP inspections and finding shortfalls, many which are serious. For example, the contract manufacturer that relied entirely on certificates of analysis from suppliers and conducted no tests to verify the identity or purity of ingredients prior to putting them into products. Here are some links to recent GMP inspection warning letters from FDA:

Hain Celestial Group warning letter, Dec. 3, 2010

Kabco Pharmaceuticals warning letter, Nov. 10, 2010

Soma Labs warning letter, Nov. 8, 2010

Swedish Bitters Herbs warning letter, Nov. 8, 2010

Vita-Herb Nutriceuticals warning letter, Oct. 20, 2010

FDA is also going after companies making inappropriate claims. It seems that some marketers still do not understand the basics of DSHEA and what claims can and cannot be made for supplements. Here are some examples of warning letters related to claims:

Maxam Nutraceutics warning letter, Oct. 12, 2010

Longevity Plus warning letter, Oct. 12, 2010

Telledant warning letter, Sept. 28, 2010

Nature's Health Company warning letter, Sept. 21, 2010

This is not to suggest that the entire industry is coming up short. In fact, there are many excellent companies who have invested great resources to ensure that their ingredients and products are safe, authentic, pure and substantiated for claims. These are the companies that will benefit from an aggressive FDA. For too long, price points have been artificially low due to adulteration issues, lack of investment in quality systems, and an unlevel playing field in research budgets. Companies have been forced to compete unfairly with those who want all of the benefits of a free market, but are not willing to uphold the responsibilities. As these practices are reduced and eliminated, the playing field will level, and those who have invested in science, quality and compliance should prosper. Of course it remains to be seen if consumers will be willing to pay the real price for a safe and effective product when the 99 cent supplements go away, but I think they will.

Here at Virgo, we are committed to helping you ensure that you are on the right side of this shakeout. From GMP training and compliance, to coverage of issues like mandatory Adverse Event Reporting, claims substantiation, Food Safety Modernization Act compliance (yes this new law applies to supplements since they are a subset of foods), to connecting you with experts and resources for your specific needs, you can count on us to be there.

As our industry works through this age of enforcement, it will improve and expand. It won't be easy, but it will be worth it for those who are committed to being around for the long haul. We look forward to sharing this journey with you. Please let us know how we can be of assistance.