New York, NY — American Conference Institute’s (ACI) 6th Annual Legal, Regulatory and Compliance Forum on Dietary Supplements, in partnership with the Council for Responsible Nutrition (CRN), took place on June 19 – 20. Regulations can be notoriously complex and frustrating, but this forum provides an invaluable resource for manufacturers to stay informed about compliance and stay ahead of the curve. The following are some important regulatory takeaways from the event:
1. Keeping up with the Food Safety Modernization Act (FSMA) regulations. One important and complex aspect of this regulation is having a Food Supplier Verification Program (FSVP) in place if you are importing material into the country. This is to verify that a foreign supplier is producing food with the same level of consumer health protections as U.S. regulation and to ensure products are not adulterated or misbranded. The importer is defined as the U.S. owner or consignee of the food at the time of entry into the U.S. However, the importer on record may or may not be the FSVP and the rules can vary slightly if you are importing dietary supplements. For example, under 21 C.F.R. § 1.511 of FSMA, modified FSVP requirements exist for three different scenarios: 1) The importer is the manufacturer. 2) The importer’s customer is the manufacturer. 3) One is importing finished dietary supplement products.
There also exists some confusion about who is the importer of record and therefore who is responsible for having a FSVP. Having clear communication is important because in some cases an importer may designate a domestic supplier or manufacturer as the importer of record, thrusting responsibility for FSVP on them. It’s also important to note that some kind of FSVP must be in place in order to be compliant. In 2017, for example, 290 inspections were conducted of a planned 325 and 183 of those inspections resulted in the company being found not in compliant with FSMA, most often for failure to have a FSVP.
2. Prop 65. There are new safe harbor warning regulations for businesses to be compliant in California. Historic safe harbor warnings sunset on Aug. 30, 2018, meaning that products manufactured before this date can use an historical safe harbor warning, but those manufactured after must meet the new standards. On-product warnings must now include a warning symbol or be set off in a black box. Other warnings, either online or on retail signage, must name at least one chemical and specify whether that chemical is known to cause birth defects, reproductive harm or both. Under this new standard, warnings must also be visible prior to purchase, whether that be on a product label in a store or in the description online. This means the previous standard of warning prior to exposure no longer applies and it is no longer enough to put the warning on a package insert, invoice or not disclose the warning on a website even if it is on the packaging.
3. Class Actions. A majority of class actions are related to Prop 65 problem ingredients. This is typically related to lead content and other toxins in food and supplements like infant/toddler formulas, herbs, energy drinks and protein shakes to name a few. In 2017, there were 688 settlements with an average settlement of $37,452.76. Another target of class actions is misleading claims. Recent targets for claims have been glucosamine/chondroitin, biotin and gingko biloba. Claims should have sufficient substantiation (animal and in vitro studies do not suffice), but claims should also be relatively conservative because it is unclear how much substantiation makes a product safe from class action. An unusual but growing number of class action lawsuits are also targeting slack fill. This is defined as containers that mislead consumers to the amount of a product actually inside the container. There has been little to no regulatory action, so it is subject to mostly class action and private litigation. Between 2013 and 2014 there were 10 slack fill cases, but between 2015 and 2016 there were 65.