Hahn Law Firm

Key Regulatory Concerns in Starting a New Food or Dietary Supplement Business

As its name suggests, the US Food and Drug Administration, or FDA, regulates drugs and foods. Drugs are subject to extensive review by the FDA. The applicant or “sponsor” must use data from scientific studies to convince the FDA that a drug is safe and effective to treat, cure, diagnose or prevent a disease or condition when used as directed. Drugs require pre-marketing approval by the FDA and cannot be legally marketed and sold in the US until the FDA has approved them.

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Aren't We Done Negotiating? What's This "Quality Agreement" of Which You Speak?

     Quality Agreements (QA's) are those legally binding documents that set out in considerable detail each party's responsibility for various activities in a regulated life sciences environment. Typically, QAs are left to last, once all the commercial agreements are signed, sealed and delivered. Once those commercial agreements are signed and celebrated, the parties may feel like they've completed their deal. They are ready to move away from negotiating, lawyers and exchanging red-lines. They are ready to actually do what they've promised each other they'd do in the commercial documents. They are ready to make products, profits and technology. So those highly technical (and perhaps tedious) QAs may seem superfluous. Not so.      QAs are an essential part of a contractual relationship in the life sciences world. The FDA considers contractors an "extension of the manufacturer's own facility." Thus, both parties are responsible for ensuring that products are not adulterated or misbranded. With respect to contract manufacturing, both parties must work together to establish and maintain quality oversight of contracted operations and the materials produced under contract. This is where the QA comes in. Indeed, QA's are so essential that failure to have one can result a warning letter from the FDA. This is true even though there is no actual legal requirement to have a QA. Here's what the FDA had to say in one warning letter:

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