Analysis: The Future of Dietary Supplement Regulation in NJ

The New Jersey Senate is currently considering legislation that would change the way dietary supplements are regulated in NJ.

Background

While the Food and Drug Administration oversees the marketing and labeling of dietary supplements it does not perform pre-market testing or require approval of the supplements before they are marketed. Studies suggest that many supplements currently available on the market are mislabeled, lack clear dosage instructions, or are corrupted with contaminants and therefore can cause serious health risks for consumers. New Jersey is in the process of taking steps to ensure the safety to Dietary Supplements through the establishment of the New Jersey Dietary Supplement Task Force as proposed in S2502, recently introduced in the NJ Senate. This task force seeks to determine what actions may be taken at the State level to improve quality assurance and safety standards for the litany of dietary supplements sold in New Jersey.

Overview: S2502 and the creation of the NJ Dietary Supplement Task Force Scope

The task force, as it currently proposed, will fall under the state’s Department of Health and will be responsible for examining and making recommendations for legislative and/or executive action with regard to the sale and use of dietary supplements in the state.

Specific duties of the task force include, but are not limited to:

  • quality control requirements
  • facility and product inspections
  • manufacturers reporting requirements
  • batch testing requirements (including whether to mandate batch testing by the State)
  • establishing a collaborative system to share test results and adverse incident reports with other states
  • the treatment of patients following adverse incidents
  • reporting adverse incidents to appropriate State and federal agencies
  • restricting or banning the sale of specific products
  • establishing age restrictions to purchase dietary supplements
  • imposing new fees or taxes on dietary supplements
  • mandating additional labeling or signage requirements
  • public education and outreach programs

The task force will be comprised of representatives from State Government as well as limited representation from industry. Specific breakdown of members include the Commissioner of Health, the Attorney General, the Director of the Division of Consumer Affairs in the Department of Law and Public Safety, along with four other public members. Two public members will be appointed by the Governor, one by the President of the Senate, and one by the Speaker of the General Assembly. The proposed legislation requires that no later than one year after organization, the task force shall submit a report of its findings and recommendations to the Governor, and the task force “shall expire upon submission of its report.”

Impact

This bill presents a large opportunity for the state to regulate dietary supplements, including nutraceuticals and signals a potential move to draw this industry closer to that of Pharmaceuticals. Being among the first of it’s kind in the US, this task force will surely cause a stir amongst vitamin shops and (perhaps most significantly) product formulators and manufacturers.

In particular, product formulators and manufacturers will face stricter QA/QC and testing requirements that may impact their operating costs. Indeed, the requirement for batch testing will cause headaches for manufacturers, but will benefit in the consumer in the long run. For the consumer, it will ensure that products will “do what they say they will do”, something that is woefully inadequate across this market. It is also important to mention that this type of QA/QC and batch testing rules that we’re seeing NJ ruminate on is similar to a trend being seen in the nascent Cannabis industry.

There does not appear to be a great deal of direct impact on the consumer–yet. Whether or not companies are able to meet regulatory requirements will evolve as the regulations get developed and put in place. Vitamin shops and other establishments selling dietary supplements will also feel an immediate effect–once the regulations get put into place. These regulations may include signage, consumer education, and reporting or banning the sale of certain products.

If NJ wants to ensure that the Dietary Supplement Task Force is indeed successful it will need to convene a diverse group of stakeholders outside of just government officials and political appointees. Bringing industry operators to the table will provide the venue to create realistic regulations while maintaining the dietary supplement industry’s competitive edge in NJ and above all, ensure that a safe, reliable product is being delivered to the consumer.

For more information, contact Brett Goldman, DMGS Manager of Special Projects

Brett Goldman is DMGS’s Manager of Special Projects. Among other things, he oversees DMGS’s blog and content production and has a keen eye for newly regulated–or soon-to-be regulated– industries.

Hope Brodkin, DMGS Summer Intern contributed to this report.

 

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