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Posted: September 24, 2007, from the October 2007 issue of P&F magazine.
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Still, the industry is always keen on cooperating with customers and regulators while remaining as transparent as possible in the interests of public health and safety. Wherever the questions and requests come from, there are strategies available to IP owners for avoiding or minimizing disclosures, responses that can be narrowly focused to address only the specific information the requester is seeking.
Limited Formula Disclosures
In January 2007, the IP task force of the Regulatory Affairs Committee of the US Flavor and Extract Manufacturers Association (FEMA) released a white paper called “Strategies for Limited Flavor Formula Disclosures.” The document stated that, “Trade secret laws protect any formula, pattern, device, or compilation of information that provides a business advantage for the owner.” And because IP law tends to be a largely civil matter, it is the responsibility of the IP owner to defend it and remedy any misappropriations.
The FEMA white paper detailed a number of formula disclosure scenarios, including the voluntary disclosure by the IP owner and disclosure due to a governmental or legal requirement. The US Federal Food, Drug and Cosmetic Act (21 USC §§ 301 ET SEQ.) allows for the collective declaration of spices, flavors and exempt colors without listing individual ingredients. There are of course some flavor exemptions, such as monosodium glutamate, which must be disclosed. In addition, there are a number of regulations that may call for additional information, including the Safe Drinking Water and Toxic Substances Control Act of 1986, the 7th Amendment to the Cosmetics Directive and the California Safe Cosmetics Act (see SIDEBAR).
Meanwhile, pharmaceuticals have their own rules, requiring that inactive ingredients such as flavors be disclosed to registration authorities. This sometimes includes disclosure of the full flavor formula. FEMA encourages IP owners to obtain copies of any statute or regulation that requires/authorizes such action.
Finally, certain illegal drug precursors such as benzaldehyde, which is a US Drug Enforcement Agency-listed chemical, must be registered and require some amount of reporting and recordkeeping, at times including limited formula disclosure for customers or regulatory authorities.
Other topics discussed: Responding to Disclosure Requests, FEMA's Place in IP Protection, Current Challenges in IP, John Cox discusses the new challenges involving ingredient country of origin
This is only an excerpt of the full article that appeared in P&F Magazine, but you can purchase the full-text version.