Dietary Supplement Overview

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Since passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA), the dietary supplement industry has grown to more than $35 billion in annual sales. This robust growth of the industry reflects not only increased interest among consumers in these products, but also means new legal and regulatory challenges to overcome. 

Porzio’s attorneys have been serving the needs of the dietary supplement industry for over 20 years. Based in Washington DC, they have a deep understanding of the  marketplace and the myriad of legal, regulatory, and public policy issues that must be navigated by established as well as start-up companies.

Our Dietary Supplement practice includes the following:

INTELLECTUAL PROPERTYPorzio’s attorneys, including those with advanced science degrees registered to practice before the U.S. Patent and Trademark Office (PTO), offer full-service representation in patent, trademark, copyright, trade secret and unfair competition law to dietary supplement companies.

We provide fundamental services including U.S. and foreign patent preparation, patent and trademark prosecution, litigation, opinions, licensing, transactions, due diligence, and portfolio management. We have particular expertise in handling more specialized matters including complex administrative proceedings such as inter partes reviews (IPRs) reexaminations, reissues, interferences and appeals to the Board of Patent Appeals, as well as appeals to the Federal Circuit and proceedings before the International Trade Commission.

When a patent dispute arises, either before the PTO or in federal District Court, Porzio’s experienced litigators work closely and collaboratively with the scientists to bring about a successful resolution as quickly and efficiently as possible. Porzio has advised and represented clients in patent, trademark, trade secret, unfair competition and copyright cases in several courts around the country, including federal and state courts in Arizona, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Maryland, Massachusetts, Michigan, Minnesota, New Jersey, Nevada, New York, North Carolina, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, and Wisconsin.

REGULATORY AFFAIRSPorzio’s attorneys regularly represent dietary supplement companies that have issues before federal and state government agencies, including the Food and Drug Administration (FDA). Federal Trade Commission (FTC), Department of Justice (DOJ), Department of Agriculture (USDA), Department of Commerce (DOC), Department of Defense (DOD), Department of Interior (DOI), Drug Enforcement Agency (DEA), Customs and Border Protection (CBP) and State Attorneys’ General.

We advise and counsel dietary supplement clients on complying with FDA and FTC regulations and guidance documents. Porzio’s attorneys are experienced in advertising and promotion, claim substantiation, health claims, current good manufacturing practice (cGMP), warning letters and other matters before the FDA and FTC. Oftentimes, FTC and FDA investigations are run in parallel with investigations by the DOJ, United States Attorneys’ Offices and State AGs. Porzio attorneys have particular experience in these matters.

Porzio attorneys routinely monitor and are in contact with regulators on new rules, guidance and policies. For example, Porzio participated with Natural Products Association on the FDA’s revised New Dietary Ingredient Guidance shortly after it was issued and continues to update and advise clients on matters of importance regarding actions being taken in Washington, D.C.

LITIGATIONPorzio has a deep bench of attorneys in litigating intellectual property, deceptive trade practices (Lanham Act § 43(a)), breach of contract and product liability cases. Our knowledge of supplements and the science behind them provide clients with an added value that other firms do not have.

PROPOSITION 65Porzio not only advises clients on complying with Proposition 65, it has also litigated warning letter cases in California courts. With the regulators issuing new rules, clients can expect to have new challenges in this area in the coming years.

PUBLIC POLICY AND ADVOCACYPorzio’s Washington, DC office is comprised of attorneys that were previously with the law firm of Patton Boggs LLP. On legislative matters before the U.S. Congress, they are in regular contact with Senate and House of Representatives Leaders, Committees, Members and senior staff. We represent clients in rulemaking proceedings before federal and state agencies. Our policy practice also involves working with clients on stratagies and advocacy training on how best to engage in grassroots lobbying efforts to better communicate their needs to their elected representatives.