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CRN Responds to FDA’s Tentative Response Regarding CRN’s NAC Petition
Washington, D.C.—The Council for Responsible Nutrition (CRN) has responded to FDA’s November 2021 letter regarding CRN’s citizen petition on NAC.
Background: As WholeFoods has previously reported, FDA issued warning letters in July 2020 asserting that NAC has been previously approved as a drug in 1963, and therefore is not a supplement, as per section 201(ff)(3)(B)(i) of DSHEA. CRN feels that this is legally invalid on multiple grounds: The records for NAC drug approval contain unreliable information; NAC drugs approved prior to 2016 appear to contain different forms of NAC from that used in supplements; the policy change is retroactive, violating the legal presumption against statutory retroactivity; and the delay between sales of NAC supplements and FDA’s warning letters was unreasonably long, violating the equitable defense of laches. CRN filed a citizen petition in June 2021 on the subject, following a letter sent to the agency in December 2020 and several meetings with FDA leadership.
FDA response: FDA delivered a tentative response in November 2021, as WholeFoods has previously reported, citing the “complex nature of [the] request” and ongoing research as the reason for not having reached a conclusion. The response added that CRN’s petition is being evaluated concurrently with a similar citizen petition from the Natural Products Association (NPA), in which NPA requests that either FDA determine that NAC is not excluded from the definition of a dietary supplement or recommend to the Secretary of HHS that they issue a regulation finding that NAC would be lawful under the FDCA. FDA then asked that interested parties submit safety information on NAC, as well as information on the earliest date that NAC was marketed as a supplement or as a food.
CRN response: CRN holds that FDA has “dodged the facial legal issues raised about FDA’s position on NAC by raising safety issues that are nonexistent and irrelevant to the legal determination,” according to a press release. In the letter, the association points to yet another legal issue: The rule that ingredients cannot be considered supplements if they’ve already been studied as drugs was only created in 1994, with DSHEA—and as NAC was used prior to that, CRN points out that drug manufacturers who may have invested in NAC research back in 1963 could not have expected exclusivity, because the law that granted it wouldn’t exist for another 30 years.
CRN adds that it is inappropriate for FDA to review its petition concurrently with NPA’s, as they request different actions from the agency: “By introducing the possibility that FDA could disregard the legal challenge to its position regarding section 201(ff)(3)(B)(i) and proceed to exercise its statutory discretion by instigating a rulemaking, NPA’s citizen petition raises issues beyond the facial legal challenge presented by CRN.”
CRN is also concerned with FDA’s request for “extensive and irrelevant” NAC marketing and safety information, which is unnecessary for the Agency to make a determination: “Safety and current market evaluation are not relevant factors” to CRN’s petition, and CRN questions whether they are relevant to NPA’s request for a rulemaking, either, given that section 201(ff)(3)(B) doesn’t request a safety evaluation to determine whether a new ingredient would be a lawful supplement.
FDA has also taken too long to respond, violating its own timeline—it has 180 days to respond to the citizen petition, and it has failed to do so. By requesting safety and marketing information, FDA may well have pushed back any response date by months, if not longer. And by combining the petition with NPA’s petition, CRN states, the agency appears to be suggesting that it will not address CRN’s legal arguments if it commences an NAC rulemaking as requested by NPA.
CRN states that it has addressed FDA’s concerns already: With regards to marketing timeline, CRN and other stakeholders have already provided evidence that NAC was marketed prior to the passage of DSHEA. With regard to safety, the letter states: “CRN is not aware of FDA raising safety concerns about NAC in its decades-long history of use as a dietary supplement, and FDA has ready access to the requested information through the FDA Adverse Event Reporting System and manufacturing facility inspections.”
Related: FDA Commissioner Nominated; CRN Notes Top 6 Priorities
NPA Sues FDA: Asks Courts to “Block Unlawful Action in NAC Situation”
AHPA to FDA: Clarify that NAC is a Lawful Dietary Ingredient
CRN is requesting that FDA reverse its position to review the CRN and NPA petitions concurrently, and provide a substantive response addressing CRN’s legal concerns. At a minimum, CRN is asking that FDA commit to substantively respond to the concerns raised in its petition within 30 days of the January 25, 2022 comment deadline. This is a time-sensitive issue: CRN points out in the letter that Amazon stopped selling NAC in spring 2021 due to FDA’s warning letters, and in the past few months, large payment processing platforms including Paypal and Shopify have blocked the use of their platforms for NAC supplement sales, doing economic damage to brands that sell NAC products.
The letter concludes: “We look forward to receiving a commitment by the Agency to bring clarity to CRN’s legal concerns in a timely manner and receiving the Agency’s substantive response.”
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2022 Natural Choice Awards Voting Now Open
South Plainfield, N.J. — Attention natural products retailers! Voting has officially opened for the Annual Natural Choice Awards 2022. Every year, natural products retailers choose the products that have had the greatest impact on their businesses by filling out an online ballot that makes it easy to vote on 20 categories in the supplements, foods, HABA, and pet products categories.
Natural products retailers who complete the online ballot are eligible to enter a drawing to have a $100 donation to Vitamin Angels made in your name.
Want to know who won last year? Check out the 2021 winners here!
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Danone Agrees to Help Mitigate Damage Caused by Pulling Out of Northeast
Danone North America, owner of Horizon Organic, will meet one of the requests of Northeast organic producer groups, in order to mitigate the damage resulting from Danone’s decision to move its milk sourcing to the west, a decision which leaves 89 organic dairies in the northeast without a market.
As WholeFoods has previously reported (1, 2), Danone made this decision in August, when it notified the dairy farm families that it would be ending their contracts and pulling out of the Northeast U.S. market, transitioning instead to larger farms closer to its western New York dairy processing plant. Many of the 89 affected farm families have been providing organic milk to Horizon Organic for decades, and had a hand in building the brand. 13,020 people signed a national petition asking Danone not to leave the Northeast, and a Maine petition garnered 2,214 signatures. The producer groups point out that Danone is a B Corp, committed to putting people above profits—and hold that this move is doing the opposite.
Danone has now agreed to extend farm contracts to 18 months. The company will also be providing a small transition payment for the affected farm families, consisting of 6% of the milk check for 6 months or $2 per hundred pounds of milk.
“We’re glad to get a response to our requests, which is one small step in the right direction,” said Sarah Alexander, Executive Director of the Maine Organic Farmers and Gardeners Association, in the press release. “There are still many details to figure out for our producers and lots of work to be done to improve infrastructure and ensure a future for organic dairy in the region. We look forward to continuing our discussions with Danone to ensure that they meet their commitments and work toward viable long-term solutions for northeast dairies.”
Five farming organizations met with Danone on November 18, in order to outline the petition requests and present two options that could help rectify the negative impact on the Northeast region. The first option asked Danone to stay in the Northeast, and invest in a processing plant that would give Danone the sustainability and reduction in truck miles that the company is hoping to obtain by shifting west. The alternative option asked that, if Danone insisted on leaving, the company could financially support the farm families: All 89 dairy farm families will either be forced into early retirement, or will have to make costly changes to their farms in order to be picked up by another company. For the second option, the group asked Danone to give a severance pay totaling $15m to all 89 dairy farmers, and to provide a $25m investment towards a new organic dairy processing plant in New England.
In a letter dated December 13, 2021, that Danone sent to the Northeast organic producer groups, Danone announced its plans to provide the affected producers with the option to extend their current contract for a total of 18-months, ending on February 28, 2023; to provide modest transition payments of an additional amount per hundredweight on the milk purchased from the producers during the last 6 months of their contracts, including to farms that have already exited Danone’s network after receiving the non-renewal notification; to provide farm consultants at no charge to the affected farms; and to explore co-investment solutions for Northeast dairy infrastructure.
“We would have preferred for Danone to stay in the region,” said Grace Oedel, Executive Director, Northeast Organic Farming Association of Vermont, in the press release “Horizon Organic has been in the Northeast region for over two decades and has a long-term relationship with all the organic farm organizations and our farmer-members. If they are determined to leave, we are glad that they are working towards meeting some of our requests to leave the region in a stronger position.”
That said, many questions still remain. “We hope to hear more specifics about how Danone plans to co-invest in solutions for Northeast dairy infrastructure,” said Kate Mendenhall, Organic Farmers Association. “The region needs a new organic dairy processing facility to be able to secure a future for Northeast dairy and provide local milk for the Northeast. We estimate that a new facility will cost at least $50 million to support the milk processing for the region as well as supplementary dairy processing needed to balance the local supply. Danone has the fiscal capability to help make that a reality for these farmers.”
And Ed Maltby, Executive Director of the Northeast Organic Dairy Producers Alliance, holds that the offering is nowhere near helpful enough. “It’s great for producers to be able to extend their contracts for an extra six months; however, the proposal lacks any substantive financial support to assist with the trauma that this decision has caused. Farmers are being offered myriad services by State governments and non-profits so any farm consultancy will not be helpful. Unfortunately, with Danone’s decision to leave the region, these farms will need to figure out what their future looks like. The contract extension will give them a little bit more time to investigate new paths forward for their families, but what they really need is a sound market with a good pay-price to give them a living wage.”
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The producer groups intend to continue working to manage the crisis and help those affected. They encourage consumers to buy directly from local organic dairy farmers and processers, as an antidote to corporate consolidation. And they request support from consumers, policy-makers, and businesses to enable investments in local infrastructure, allowing farmers to regain control of their own work and products and ensure that consumers have access to healthy and locally produced food.
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PLMA Cancels January Trade Show, Sets New Dates
PLMA has canceled its Private Label Trade Show due to the omicron variant and overall surge of COVID-19 cases.
A statement on PLMA’s website additionally cites the reinstatement of corporate travel bans and international travel restrictions, adding: “The safety and health of our members, exhibitors, attendees, guests, and staff will always be our main priority.”
The show was scheduled to take place January 30-February 1, 2022, at the Donald E. Stephens Convention Center in Chicago.
PLMA has set new in-person dates: November 13-15, 2022.
Plus, retailers, suppliers, and other industry professionals will receive invitations in the coming weeks to participate in PLMA Global, a worldwide online trade show to be held March 28-31.
Questions can be directed to info@plma.com, or to +1 (212)972-3131.
Related: The Value of Private Label
Expo East 2021: 14 Trends to Watch
Kicking Off NPEE With a Healthy Harvest
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NPA Sues FDA: Asks Courts to “Block Unlawful Action in NAC Situation”
Washington, D.C.—The Natural Products Association (NPA) announced that it has filed a lawsuit against the Food and Drug Administration (FDA). At issue: the status of N-acetyl-L-cysteine (NAC). NPA is requesting that FDA “cease its unlawful retroactive application of the Food, Drug, and Cosmetic Act” against NAC.
As WholeFoods has previously reported, industry experts point out that NAC has been marketed as a dietary supplements for decades with FDA’s knowledge. NPA notes that NAC been used safely in products pre-DSHEA, and that it is a common amino acid found in common foods including onions and garlic. Yet in July 2020, FDA issued warning letters asserting the product was previously approved as a drug, and therefore is not a supplement.
NPA explained in the release that it is “defending the industry’s right to provide a product with an exceptional 30-plus year safety record and for consumers’ access to safe and well-regulated supplements.” NPA also pointed out that FDA has not established a public health risk for NAC, or any other substantiated basis to justify why the agency is “spending effort and resources to damage the industry.”
The lawsuit outlines NPA’s position, and notes: NPA members who have been selling NAC for years, if not decades, have seen their sales dry up as result of having to preemptively pull products from the shelves by virtue of FDA’s unlawful decisions.
Related: CRN Disappointed With FDA Tentative Response to NAC Citizen PetitionAHPA to FDA: Clarify that NAC is a Lawful Dietary Ingredient
NAC—The Latest Health-Success Story to Become an FDA Target
FDA’s actions could have implications beyond NAC, NPA pointed out in its release, noting: Our members and the industry are concerned that that the FDA is exceeding its authority, and that the uncertain regulatory climate created by this action will have a damaging economic impact on supplement manufacturers. Retroactively applying DSHEA to a product that was clearly being marketed as a dietary supplement prior to 1994 sets a precedent that could extend to other popular products, including vitamin C, and theoretically, everyday products like table salt and caffeine.
NPA also noted that FDA’s motivation in the case of NAC is unclear. This is alarming, the association stated, because the FDA claims its resources are stretched thin, yet it is focusing “valuable time and resources—during a pandemic—to go after a product that has an outstanding safety record, and that has been legally marketed and sold as a dietary supplement for decades.”
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