A large dietary product manufacturer is recalling all lots of dietary supplements that it manufactured over a six-year period as a result of a consent order that was reached in the Eastern District of New York. The result is one of the largest recalls ever of dietary products. Included in this recall are over 1,200 brand names of dietary supplements, greatly impacting the supply of such products on the market. Countless products will need to be pulled from store shelves and a major maker is out of business for now.
ABH Nature’s Products is a contract manufacturer of dietary products. There are multiple names under the same corporate umbrella that also include ABH Pharma and Stocknutra.com. The company has found itself in serious regulatory hot water due to a number of violations that include both how its products are made as well as claims that it made in advertising its products. At best, the company was very lax in how it made and sold its products. At worst, ABH exhibited a blatant disregard for both quality control and federal laws.
ABH Failed to Follow Good Manufacturing Practices
One of the major issues with dietary supplements and even supplements, in general, is the quality of the products. Unfortunately, companies are putting low-quality products onto the marketplace. Some products may not be high-quality, but when the way that these companies are making their products violates the law, it crosses a line. Sometimes, marketers choose to sell products from contract manufacturers that have little regard for legal standards that companies are required to follow. At some point, a persistent failure to follow best practices can result in a situation where regulators must take firm action to protect the public. This is what happened in the case of ABH.
The FDA detected numerous violations of good manufacturing practices over the course of numerous inspections over a several-year period. Not only were there issues with the manufacturing, but the company also distributed misbranded and unapproved supplements. The company made wild and unsupported claims that its dietary products could be used to treat ailments ranging from cancer to HIV. These are “off-label” uses that were not approved by the FDA. The dietary supplement industry already includes enough questionable practices without factoring in that manufacturers are making far-fetched claims that are not rooted in reality.
ABH’s Products Were Plagued By Numerous Issues
When it comes to manufacturing, the FDA noted numerous failures. These included the fact that ABH did not conduct any tests to ensure that its products met purity standards. There was little to no quality control when it came to both the safety of the products as manufactured or even the effectiveness. The FDA found that the company did not investigate and adequately deal with consumer complaints.
As a result, the FDA filed a lawsuit against the companies. The court issued a consent order and the company and its owner agreed to be bound by the order. This means that there is no appeal and the penalties in this order are to take effect immediately.
For now, all of these companies are prevented from making dietary supplements. The consent order removes them from the marketplace. If they want to resume production, they must take several steps to be allowed to do so. These would include hiring an independent expert to inspect the factories in order to ensure that all manufacturing issues have been corrected. Then, the company would also need to hire a labeling expert to verify that the company is not mislabeling its products.
ABH was required to destroy all of its own supplements that were in its possession. In other words, if the company wished to resume manufacturing these products, it would have to start from scratch only after it takes the remedial measures set forth in the consent decree.
Regulatory Action Took the Better Part of a Decade
While the FDA ultimately took strong action against these companies, it took quite a while for the regulator to finally act. As a result, the recall encompassed nearly seven years of products as the company continued to sell products that failed to meet standards while the agency delayed action. Legislators have questioned the delay in FDA action. As a result of the delay, countless consumers were put at risk of products that did not meet specifications.
The FDA began the process of acting as far back as 2012, when it issued a warning letter to these companies. However, from that time until the time that the consent order was issued stretched for almost seven years. During the interim period, the regulatory action proceeded in almost slow motion. The company ignored FDA letters for months on end, and the agency seemed to be in no hurry to push the case forward. In the meantime, there were gaps as long as 18 months in the communications between the two parties.
In general, Americans are at risk when they buy dietary supplements. They often have little to no way of knowing whether the supplements will actually do what the manufacturer claims. As a result, the public is in the dark about a substance that they are taking regularly in the hope of losing weight.
Some of these products can be downright dangerous. In the case of the diet pill Fen-Phen, dozens of Americans lost their lives because the defective pill caused heart attacks and damage. Countless others required surgery or suffered other long-term heart damage. Here, the issue was one of quality and standards as opposed to defective and dangerous products. However, all it takes is one manufacturing error when there is lax oversight, and consumers can be at risk.
While there have been no injuries reported by the company’s violations to date, customers should be on the lookout for any adverse side effects if they have used these dietary products. If they experience any complications, they should seek prompt medical care and contact a product liability attorney to discuss their legal options and whether they could be eligible for financial compensation. The Law Offices of Sadaka Associates handle such cases and can provide a free evaluation of your case. Call them today.
Learn more about Drug Recalls.