UNPA REGULATORY UPDATE: NUTRITION FACTS, MASTER FILES AND PROP 65By Frank Lampe
This article originally appeared in the Summer 2018 issue of ingredentonline.com’s quarterly magazine.
Like them or not, regulations are the backbone of the dietary supplement industry. Here are three areas of regulation in play, which will all have a major impact on supplement manufacturing and production in the years to come.
Supplement Facts: compliance dates extended, but still lots to act on
Effective July 2016, the U.S. Food and Drug Administration enacted a major revision to the Nutrition Facts labels on foods in order to better provide updated nutrition information to assist consumers in maintaining healthy dietary practices and to help them make more-informed food choices. Many of these changes also impact the Supplement Facts labels for dietary supplements.
Based on comments it received, FDA delayed the compliance date for the label changes for manufacturers with $10 million or more in annual sales to Jan. 1, 2020. Manufacturers with less than $10 million in annual sales will now need to comply by Jan. 1, 2021.
As with the new food label, the agency will no longer require information on vitamins A or C (unless you’re making a specific claim or for product requirements) or calories from fat, although inclusion is allowed, if desired on supplement labels. However, vitamin D, potassium and “added sugars” content must be declared, and there are new rules about how fiber and sugars are listed.
Of interest, the new labels require a footnote for labels for “certain products represented or purported to be for use by children 1 through 3 years of age.”
Most important, perhaps, is that “daily values” have been updated, based on new science, and these changes [ital]are[ital] extensive. For example, vitamin C daily values move from 60 mg to 90 mg; vitamins B6 and B12 values were decreased, while those for phosphorous, magnesium and potassium were all increased.
New for the updated Supplement Facts label is a required order for nutrients. For example, when declared, choline must follow potassium on the label, and fluoride must be at the end of the list of nutrients.
Manufacturers will also have to rethink and update units of measure to determine the new daily values. For example, the measurements for vitamin D and vitamin E as a tocopherol are changing from IU to mcg and mg, respectively. Further complicating things, according to analytical testing lab Covance, FDA considers the addition of synthetic tocopherol at half the potency of the natural form of the vitamin; other related forms, including beta, delta, gamma and tocotrienols “may have antioxidant properties of value to a product but are not to be counted toward vitamin E content.”
Finally, since the number of calories derived from supplements is insignificant, the requirement that food manufacturers will have to follow around displaying calories on supplement labels will not apply for supplement manufacturers.
Considering the complexity of many dietary supplement formulations and products, proactive supplement manufacturers are already well on their way toward researching, testing and then implementing the changes to their product labels—and formulations, well ahead of the extended compliance deadlines.
NDI Master Files: A good idea
It’s been almost two years since FDA proposed master files as part of its revised New Dietary Ingredient (NDI) guidance. NDIs, required for all new dietary ingredients introduced into the market after October 1994 as part of the landmark Dietary Supplement Health and Education Act, is the very last aspect of the law that has yet to be finalized.
The concept of master files—a dossier containing detailed and confidential safety and manufacturing data—is used in pharmaceutical regulation and approval as well as in drug development, and the NDI draft guidance of August 2016 proposes this for supplement ingredients, as well.
But who gets to use these files for their own NDI notifications? Supplement brand Herbalife proposed the master file concept for supplements in 2011 comments to FDA in response to the agency’s first NDI guidance and suggested that whomever submitted the master file could provide written permission to allow another company filing an NDI to rely on that information.
“A system is needed to avoid unnecessary duplication as regards NDIs for the same product sold to different manufacturers," Herbalife said in its comments. “Also, a number of dietary supplement manufacturers produce products containing the same ingredients. Subsequent NDI notifications for supplement compositions relying in part upon the same ingredients would refer to the relevant master files and would not need to include additional safety data about the referenced ingredient."
The United Natural Products Alliance (UNPA) thinks this is a useful idea as it gives companies greater control over their intellectual property and addresses the issue of research piggybacking—that is, companies citing research specific to other ingredients and processes, including safety and toxicology data, and then using that research to back their own NDI filing.
The alternative would be for companies that have filed an NDI to simply share this proprietary information with their clients under a non-disclosure agreement, where you would disclose all of the proprietary data to the client.
Meanwhile, as industry waits for the publication of comments and FDA’s analysis of those comments from the revised NDI guidance and the issuance of a final regulation, FDA is attempting to understand if the master file process is of value to the supplement industry and is trying to gauge whether industry would utilize it.
When you consider the not-insignificant administrative burden master files would create for the agency as well as its well-known limited resources, it’s a question worth pondering. Who would pay for the master file administration? Are supplement user fees in our future to cover these costs? UNPA will report on this critical conversation as we learn more.
California’s Prop 65: August 2018 compliance date is looming
California’s Proposition 65, also known as the Safe Drinking Water and Toxic Enforcement Act of 1986, requires businesses to provide warnings to Californians about “significant” exposures to chemicals that cause cancer, birth defects or other reproductive harm. The law requires the state to publish a list of chemicals known to cause cancer, birth defects or other reproductive harm, which is updated annually and now includes approximately 900 chemicals.
What’s changing is that the revised warnings will alert consumers to the specific chemical(s) in the product, as well as how they might be exposed—and how they can reduce or eliminate possible exposure. The state also amended the responsibilities of manufacturers and retailers in informing consumers about the warnings.
Unlike the delay in federal label changes mentioned above, the Prop 65 changes come into effect on Aug. 31 of this year. If you sell products in The Golden State—the world’s fifth largest economy—the clock is ticking.
Key amendments to the labeling law:
This extremely brief review of the changes to the Prop 65 requirements is in no way complete or comprehensive.
We encourage all ingredient suppliers and manufacturers to take the appropriate steps to ensure compliance with the labeling changes mentioned above and to consider the impact of master files as part of any final NDI guidance. In addition to the obvious need to be compliant with ever-evolving state and federal regulations, the value of exhibiting leadership around these issues demonstrates to consumers that responsible industry is highly regulated and deserves their continued trust and respect.
Frank Lampe is VP, Communications & Industry Relations, for the United Natural Products Alliance (UNPA), an international trade association representing more than 100 leading natural products, dietary supplement, functional food and scientific and technology and related service companies that share a commitment to provide consumers with natural health products of superior quality, benefit, reliability and sustainability. For more information, visit www.unpa.com.