ODIs, kratom, CBD, SSCI and more: NPA reviews ‘exciting’ 2017

By Daniel Fabricant, PhD, CEO & President, Natural Products Association

19-Dec-2017 - Last updated on 16-Aug-2019 at 14:00 GMT

This year wasn’t a time to take in a play or go about things leisurely, outside of the beltway there may appear to be gridlock due to congress but a new Administration set the tone early in 2017, putting forth some great opportunities for the natural products industry. It was a busy year in Washington with the NPA hard at work educating new policymakers about the value our products bring to consumers and to the U.S. economy.

We knew 2017 was going to be an exciting year for the natural products industry, and we couldn’t have been more right. We’re pleased to share some of the events that shaped the industry this year and the work that NPA is doing to support it here in Washington and across the country.

Regulatory and Filings/ODI Book

One of President Donald Trump’s top priorities upon taking office was to streamline regulations and make the economy more efficient for business. Booming demand for natural products means that a streamlined and efficient regulatory structure is critical in order to protect consumers and public health. NPA has been pleased to work with the Trump Administration to ensure that health conscious American consumers have access to the products they use every day. To that end, per the NPA citizen’s petition we have an 18-month stay on Nutrition and Supplement Facts labeling implementation, so that we only have to make label changes once, versus twice when we have a better idea on what will be required for GMO-disclosure and are awaiting word on a second chance to comment on the removal of 26-types of fibers (and why we don’t want them removed), the ability to label CFU on probiotics on the NF or SF panel, added sugars labeling (currently it’s only a negative disclosure), sodium and the validity of FDA’s eye tracking study.

Additionally, true to the Administration’s word the FDA and other agencies also recently expanded the comment period on reviewing redundant regulations. NPA highlighted a number of regulatory issues for the Trump Administration to consider, including, but not limited to: one regulation that (EPA) would classify dietary supplements under the same category as pharmaceutical drugs, a slap in the face of DSHEA; removal of the notice on vinpocetine to remove it from commerce, FDA isn’t going to ban it so let’s stop the confusion in the marketplace; and consideration of the small business economic impact on the industry which had not been done for the past 3 years by the agency on all rules, regulations and guidances, including the NDI guidance.

While we’re on the topic of the NDI guidance, everyone’s favorite debate topic, This year the FDA held a public meeting, Development of a List of Dietary Ingredients that Pre-Date the Dietary Supplement Health and Education Act of 1994 (DSHEA), to discuss the development of a list of pre-DSHEA dietary ingredients. It became apparent that the agency would not develop a list. As part of NPA’s efforts to work with the FDA, NPA has developed a book that includes a comprehensive list of pre-DSHEA dietary ingredients. This book is the first, and at present, only, of its kind and should serve as a valuable tool for industry regulatory divisions, retailers, industry consultants, as well as state and federal regulators. This book represents a considerable investment of NPA’s resources and took over 2 years to develop but will help the industry to establish an initial list of ingredients (approx. 1850 entries) that will not require an NDI notification.

Kratom and CBD

I always get asked about it so here goes. Kratom has been a public health target for over six years, and its surging growth in use and availability has been an unfortunate but real example of the federal government’s unwillingness to use existing authorities to enforce the law. Recently we have been pleased to see FDA Commissioner Gottlieb speak out about this dangerous product as the opioid epidemic continues to sweep our country. Kratom, especially if it is labeled to treat pain or worse cure addiction is not a lawful herbal supplement and worse, it may be contributing to America’s opiate epidemic. We are eager to work with the authorities and our members to help turn the tide against illegal Kratom products and ensure that it is seen as what it is: a potentially dangerous narcotic that has no place in health or wellness.

Our concerns regarding CBD are similar to what we have made public in the past about Kratom. While CBDs might not have the same safety concerns as Kratom, there is a path for these products to come to market. Companies should play by those rules, and shouldn’t try to circumvent them just because they are perceived to be difficult or expensive. In either case, responsible companies ought to put together dossiers for a New Dietary Ingredient Notification.

WIC

Dr Daniel Fabricant, NPA

On the legislative front, it wasn’t all quiet, for the first time ever, the industry has been working to expand access to nutritional supplements and natural products on WIC. The “WIC Improvement Act”, H.R. 3529, will expand WIC to give low-income families equal opportunity for access to low-cost, high nutrient alternatives, like multivitamins.

Since 1978, the WIC Supplemental Food Program has served low-income, at risk pregnant, breastfeeding, and postpartum women, infants, and children up to age 5. The WIC program provides Federal grants to States for supplemental foods, health care referrals, and nutrition education. The program has grown significantly in its’ nearly 40-years of existence, and it now serves approximately 8 million participants. Tell your congressperson to support the bill, it takes 30 seconds to send them a letter through www.saveoursupplements.org

Enforcement Actions

Our educational foundation, the NPF, continued its strong self-regulatory work in 2017 under the guidance of Dr. Hilmas. With 70 cases evaluated resulting in 21 cases receiving warning letters. Twelve of those were referred to Federal Agencies one of the referrals resulted in a prison sentence.

SSCI

While we’re on the topic of self-regulation, I have to mention the industry efforts on SSCI. Over a year ago, NPA in working with retailers like GNC and WalMart established the SSCI with the goal of developing an overarching framework for certification schemes through the entire lifecycle of a product. This is done by benchmark existing or novel international safety and compliance standards against expert-derived, unifying safety and compliance criteria. Having these measured common criteria allows the industry to create a harmonized and verified control system to produce and deliver safe and compliant supplements and evaluate our overall areas of excellence and areas where we may need to make improvements before they have an impact on the consumer. To that end a number of manufacturers, retailers and certifiers have given their time and efforts and it has resulted in pilot audits to further the development of the unified compliance criteria and the tools needed for such. These pilot audits should result in the first schemes being benchmarked and ready for all in the industry at some point in the first half of 2018. Get involved now with ssci @ ssci-global.org

States

While there weren’t any Attorney General lawsuits filed against the dietary supplement industry to mark the year, the state legislatures were active and we must stay aware of those threats.

In Massachusetts, a new proposal by state Rep. Khan would place onerous restrictions, most notably on small businesses, by forcing popular nutritional supplements behind the counter and prohibiting minors from purchasing products and ingredients that are found in commonly used foods including fish, meat and dairy products; protein powder used by Athletes including Tom Brady; and a cup of coffee. Dietary supplements are simply natural ingredients found in foods, and restricting access to them is unfair to Massachusetts consumers, hurts responsible retailers and drains the state budget through lost sales taxes. Nobody wins. The Natural Products Association was the first to testify on the issue in October and continues educating the legislature about supplements which are used safely every day by millions in the Commonwealth to maintain and improve their health and wellness.

In New York a similar proposal wanted to put Creatine behind the counter, NPA and NPA East sprang into action to meet with the state legislature and educate them on the issue. We look forward to greater collaboration with the regions on all threats to the industry, and those threats will be there in 2018. As usual, and good news for the industry, we will be there to.