International Regulations on Herbal Supplements under law in Virginia

Herbal Supplements

Camilla Geetz, Legal Fellow, works at the Program on Environmental Health and at the Climate Legal Institute. Scott Hochberg, Staff Attorney, works in the Climate Law Institute on strengthening protections for air quality, automobile efficiency standards, and EV programs. Clare Lakewood, Legal Director, Climate Matters, is Senior Counsel, works at the Climate Law Institute.

Virginia Environmental Legal Forum (VELF) VELF provides a forum for law students interested in environmental issues and in embedding sustainability practices in their day-to-day lives and careers. Virginia Sports & Entertainment Law Society – The Virginia Sports & Entertainment Law Society provides an educational forum for students dedicated to exploring the intersection of sports, entertainment, and law.

American Constitution Society – The JLSA provides cultural, educational, and social programming for Jewish Law students, as well as serving as a resource to the rest of the law school. PILA provides scholarships for students taking voluntary or underpaid summer internships in the public interest, teaches public interest law to the Law School community, and serves as a support network for students interested in public sector work. Muslim Law Student Association (MLSA) – The MLSA provides educational, cultural, and social programming to promote a sense of community within the Law School, while seeking to raise awareness about the legal issues that are relevant to Muslim-Americans.

A forum to discuss issues that impact Asian American Law students and the university community at large is also provided through this organization. This is a volunteer-based network, including medical providers and public health professionals, organized on the ground to enhance health and safety in communities.

To further support public health goals in the Dietary Supplement Health and Education Act (DSHEA), FDA has also issued guidance documents that provide nonbinding recommendations to assist industry in understanding and implementing all regulations and laws. Notification of New Ingredients Although notification of new ingredients in dietary supplements is a DSHEA regulatory requirement, implementation has been troublesome.

The FDA regulates dietary supplements pursuant to the Dietary Supplement Health and Education Act of 1994, but because this obsolete legislation has major gaps, the agency is not effective or efficient at protecting the publics health. The dietary supplement industry is regulated by the FDA, mostly in accordance with provisions in DSHEA. Dietary supplements may include generic health claims, nutrient-content claims, or structural-function claims.31 Some scientific evidence is required to be submitted to FDA for health claims alone, establishing a direct relationship between use of a supplement and reduced risk for illness.

As an organizing body for standards that seeks to advance public health, the U.S. Pharmacopeia supports manufacturers of dietary supplements in continuing to produce quality products that address the needs of consumers. USPs DSC also includes General Chapters related to Good Manufacturing Practices that manufacturers can use to help ensure their supplements are made using safe, sanitary, and well-controlled production practices.

While FDA may order recalls for food additives, mandatory product listing requirements do not apply to drugs, which must be recalled by manufacturers on their own initiative. In cases in which supplements are contaminated with drug ingredients, a loophole in the law makes the agencys authority for a recall murky.

California, New York, Texas, Illinois, and Connecticut all have laws that govern human milks purchase, processing, distribution, use, or reimbursement. At least three states have laws related to nursing homes and to breast feeding. Thirty-one states, the District of Columbia, Puerto Rico, and the Virgin Islands exempt breastfeeding from state indecency laws.

Thirty-two states, the District of Columbia, and Puerto Rico have laws regarding breastfeeding in the workplace. Louisianas law requires some government buildings to have adequate areas for nursing and lactation, while Illinois requires the state capitol building to include at least one nursing mothers room. The law requires some public health buildings to provide an enclosure, sanitary space, in addition to the restroom, containing a chair, a table, and an electric outlet, that is accessible by members of the public to pump breast milk.

Among its many provisions, Section 4207 of the act amends the Fair Labor Standards Act of 1938 (29 U.S.C. 207) to require that an employer give a worker a reasonable time off for the expression of breast milk for his or her nursing infant during a one-year period following delivery, whenever that worker has the need to express milk. These requirements do not supersede state laws providing greater protections for employees. Under the existing law, emergency shelters cannot be reimbursed for meals and supplements provided to individuals older than 18. It also provides for reimbursement of student loans to nurses working as instructors at nurse-training schools.

Last year, the FDA and Federal Trade Commission (FTC), which enforces antitrust and consumer-protection laws, sent more than 100 joint alert letters to dietary supplement manufacturers who were selling products that made fraudulent claims about treating or preventing the COVID-19 pandemic. The number of food additives sold in the U.S. (see box, following page 1) has increased greatly since the passage of the Dietary Supplement Health and Education Act (DSHEA), going from approximately 4,000 in 1994, when the act went into effect, to over 90,000 in 2014.

Ross Middlemiss is a graduate of the University of California, Hastings College of Law, and received his undergraduate degree in Biology from Sonoma State University. Paulo Lopes holds a Juris Doctor degree and Master in Public Policy from American University, and a Bachelor of Business Administration in Finance from The University of Texas at Austin. Stephanie Kurose received a law degree from the Washington College of Law of American University, focusing on environmental law, and an M.A. in Global Environmental Policy at Lewis & Clark Law School. Jaclyn Lopez has presented, written, and taught courses on environmental law and policy issues. Allison Melton has also worked in energy and conservation law, representing clients in Freedom of Information Act and National Environmental Policy Act cases; she holds a Juris Doctor from the University of Colorado.