Last week, FDA announced the action, which was filed as a civil complaint by the Department of Justice in the US District Court for the Eastern District of New York. It alleges that the supplement firm Riddhi USA Inc and its owner and president Mohd M. Alam, engaged in the distribution of dietary supplements that were adulterated and misbranded. The complaint further alleges that these dietary supplements were prepared, packed, and held under conditions that do not comply with current good manufacturing practice regulations for these types of products.
One concern that formed only a footnote in the allegations should loom large for supplement firms, said Larisa Pavlick, vice president of regulatory and compliance for the United Natural Products Alliance. Riddhi had many labeling failures, but in particular it failed to label a major allergen: Soy. Allergens don’t come into play very often in supplement manufacturing, but that doesn’t mean that dietary supplement manufacturers don’t need to be up to date on the latest requirements under the Food Safety Modernization Act.
“There’s this whole misunderstanding out there that dietary supplement manufacturers are not subject of FSMA. They are exempt for only two of the subsections of FSMA,” Pavlick told NutraIngredients-USA.
“In Part 111 (the federal rules governing GMPs for dietary supplements) you have to monitor for all potential contamination. But Part 117 (FSMA) specifically talks about allergens,” she said.
Specific part of preventive controls program
Pavlick said identifying and controlling for allergens will form part of a company’s preventive controls program. The four parts of this requirement are controlling for allergens, a sanitation control, a process control and a supply chain control. Allergens are a special category, not only because of the potential risk they pose to consumers, but because of how they are integrated into the final product.
“An allergen, once it’s in there, can’t be eliminated as part of your process. You can’t filter it out or cook it out,” Pavlick said.
Food companies have dealt with these issues for years, especially in light of the ubiquity of peanut ingredients in the food chain. Pavlick said facilities that handle peanuts typically have dedicated lines and rooms with separate air handling facilities for products that contain these ingredients to eliminate the possibility of cross contamination. For peanuts, contamination even in the parts per billion can pose a risk.
The potential allergens that typically show in dietary supplements are fewer, Pavlick said. Soy, in the form of soy lecithin, and glucosamine from shellfish are the two most prominent.
Another that she said has only turned up recently is mixed tocopherols from soy added to fish oils as a preservative. Because of this, fewer supplement firms are as familiar with allergen protocols as are food companies, she said.
“Most dietary supplement manufacturing facilities don’t have dedicated lines solely to address allergen risk,” she said.
Dim view of ‘may contain’ statements
Increasingly, some manufacturing operations, such as the production of extracts, are carried out overseas, which means an allergen could already be in the ingredient before it gets to the domestic assembly line. Pavlick said this new, heightened requirement under FSMA will place pressure on a company’s supply chain verification. Companies will have to be much more diligent in verifying that if the supplier is the one doing the allergen controls, that these are done in accordance with the rule. This could mean that suppliers may have to alter their business practices or retrofit production machinery if they are handling potential allergens in a mixed facility. The days of the ‘may contain’ statements may be numbered.
“FDA hates those ‘may contain’ statements, like ‘may contain wheat or tree nuts.’ What FDA wants you to do is to get to point where you know one way or the other. The proliferation of the ‘may contain’ statements on labels means the allergen declarations are becoming less and less useful for consumers who have allergies,” she said.