Little-Known Regulations Could Have Big-Time Consequences

By Taylor Wallace, PhD, senior director, scientific and regulatory affairs, CRN | February 15, 2012

All too often I find myself reading yet another story about dietary supplements where the author of the article incorrectly asserts that dietary supplements are unregulated. Not only is this incorrect, but it is also potentially damaging to the responsible industry’s reputation of providing safe and high-quality products to consumers.
With the passage of DSHEA in 1994, Congress reaffirmed that dietary supplements should be regulated as a category of food. But DSHEA is not the only law that affects our industry. The Food, Drug and Cosmetics Act has several provisions and amendments that apply to supplements. The recent Food Safety Modernization Act is another law that directly affects the industry. Even the Bioterrorism Act of 2007 also has implications for dietary supplements. Within these very complex laws are a number of smaller, lesser-known regulations that multiple agencies have overlapping jurisdiction to enforce. Do you know what these additional regulations are and, more importantly, are you aware of how they may impact your business? If you don’t, or if you do and you’re not abiding by them, we continue to run the risk of being branded an unregulated industry. All companies manufacturing dietary supplements need to have a thorough understanding of DSHEA, as well as other laws and regulations that may be applicable to their specific types of products. The good news is one of the major benefits of CRN membership is you have experts at your fingertips.
So how do these little known regulations affect your company? Well that depends on what you are producing and selling, and in some cases, these regulations can be very specific to a single production technique or specific ingredients used. When it comes time for a GMP inspection, these little known regulations can easily trip up a company not well-versed in these regulations. For instance, if an FDA inspector comes to perform a GMP inspection and asks you if you produce a liquid multivitamin and the answer is yes, the next question he could ask is: are you in compliance with the Domestic Acidified and Low-acid Canned Foods regulations? If you’re not, then right off the bat you are suggesting to the inspector that there may be other problems ahead.
Starting off on the right foot may be as simple as knowing what applies to you and your products. When Congress passed the Bioterrorism Act in 2007, it stipulated that every company that produces a food product must register their company. This was a pretty straightforward requirement and most companies had no problem meeting this requirement. But when Congress recently passed the Food Safety Modernization Act in 2010, a new regulation requires companies to re-register every two years. If you are unaware of this new rule, you could find yourself in hot water. For companies that produce fish oil supplements, there is a whole host of additional regulations dealing specifically with seafood products that very well may be applicable to your business. So the big question is: how well do you know all of these smaller, more obscure regulations?
Make no mistake, when FDA performs a GMP inspection, the agency can nab you for any regulation it has been tasked with enforcing. So don’t presume that the inspector will simply go through a basic checklist and ignore regulations that aren’t contained in the GMP regulations. During a recent CRN industry webinar, FDA officials emphasized concern when discussing the difficulties some companies are facing when it comes to passing GMP inspections. Familiarizing yourself with so many complex rules and regulations is a herculean task by any standard. While taking the extra step to ensure compliance may at times seem rather duplicative, these important steps can help a company from being caught unprepared.
So how can you assure compliance with regulations that pertain to your products? Well for starters you can join a credible trade association—one where membership provides not only access to a highly qualified and experienced team of regulatory and legislative experts, but also interaction with the same kinds of experts at highly reputable supplement manufacturers, ingredient suppliers and regulatory/legal consultants. Remember, you have an obligation to understand and abide by all regulations.

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