In the past few years, we have noticed the ever-increasing importance that FDA is placing on Good Manufacturing Practices (“GMP”).  Whether you manufacture in-house or use contract manufacturers, it is essential for your business to comply with FDA’s GMP guidelines to avoid FDA scrutiny (and the potential warning letters and consent decrees that may follow).  As we head into 2013, this upcoming year will be no exception, as FDA is likely to crack down even harder on GMP compliance in the dietary supplement industry.

Among other issues, below we have summarized the current hot topics involving GMPs.

• Contaminated & Adulterated Products
  • Defects in raw ingredients are often the reason a product is considered adulterated.  Therefore, it is important to verify the specs for raw ingredients before manufacturing the product, especially for weight-loss, bodybuilding and sexual enhancement products.
  • Red Flags: If you have had other GMP issues in the past or are basing your GMP compliance on the fact you meet OTC drug manufacturing standards, you may be signaling risky behavior to FDA.

• Product Recalls
  • Beyond adulteration, FDA’s eyes are on product recalls involving pathogens (i.e. salmonella) and undeclared allergens in products within the dietary supplement industry.

• Serious Adverse Event Reporting
  • FDA also has been paying attention to serious adverse event reports, as we have seen with certain energy drinks, to determine potential high-risk areas that deserve its attention.

• Distributor Responsibility
  • From the FDA’s perspective, own-label distributors are manufacturers and will be evaluated as such for GMP compliance.
  • In auditing distributors, FDA is likely to pay close attention to the prevalence of :
    • Quality control (or lack thereof) and quality agreements in place with each of the manufacturing partners
    • Identity testing
    • SOPs (i.e. product return procedures; holding and storage of dietary supplements)

• Consent Decrees
  • What is it?
    • According to the FDA, “a consent decree for permanent injunction restrains a company from distributing any products into interstate commerce, until they comply with FDA regulations and allows the FDA to assess damages against the company for any future violations of the law or the Consent Decree.”
  • While Consent Decrees do not result from first time violations, they can be an option for companies who fail to make improvements after the FDA submits its Form 483 or warning letter.

Another important part of GMP compliance is to document and delineate who is responsible for each level of the process.  Whether you do this through indemnity agreements or in insurance policies, it is crucial to describe the responsibilities of each party in the manufacturing process to ensure compliance with GMP regulations.

As always, if you are in need of legal counsel for GMP compliance or any other current or reasonably anticipated future regulations in the dietary supplement industry, call us anytime at 516-294-0300.

*Our gratitude is extended to “The Tan Sheet” (November 26, 2012) for providing the content for this post.