Proposed updates hint at dietary supplement legislative reform

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| 19 July 2022 | By Krista Hekking, JDMiriam Guggenheim, JD  | ©

The dietary supplement industry has grown in the 28 years since the passage of the Dietary Supplement Health and Education Act (DSHEA), but the legislative reform has not been commensurate with those industry changes. This article discusses six key legislative updates proposed by FDA, industry, and consumer groups, suggesting reform is on the horizon for DSHEA.
 
Keywords – dietary supplement, Dietary Supplement Health and Education Act, DSHEA, CBD, hemp, listing, Pharmanex, NAC, third-party inspection
 
Introduction
The DSHEA ushered in a new era of opportunities for dietary supplement manufacturers and consumers. The US Food and Drug Administration’s (FDA’s) regulation of dietary supplements before DSHEA imposed significant regulatory burdens that some feared would quash the burgeoning industry.1 DSHEA clarified that dietary supplements were a separate subcategory of foods and not subject to the pre-approval requirements of food additives and imposed a new framework for overseeing safety that expanded consumer access to dietary supplements and allowed the industry to flourish. At the time DSHEA was passed in 1994, there were about 4,000 products on the market, with net sales of $4 billion per year.2 Today, some estimates put the number of products on the market as high as 80,000, with sales reaching more than $50 billion per year.2-4
 
While the industry has grown, DSHEA has not grown with it. There have been no legislative updates to DSHEA since it was signed into law in 1994. Significant technological developments have been made since the law’s passage, including the explosion of novel probiotic strains, synthetically produced dietary ingredients, and cannabidiol (CBD) from hemp. Congress was not contemplating these technological innovations at the time of enactment. Now, almost 28 years later, the law that was created to help increase consumer access and promote the growth of the dietary supplement industry is holding both groups back in some ways, as we will discuss here.
 
As a result, the FDA, industry, and nongovernmental organizations (NGOs) have advocated for updates to DSHEA – reforms some have called DSHEA 2.0.5,6 While numerous proposals have been floated by industry and the agency, little progress has been made on making them a reality. But several factors present unique opportunities for legislative progress.
 
First, the Prescription Drug User Fee Act (PDUFA) VII is set to be passed this summer. The current five-year authorization will expire on 30 September 2022, and the reauthorization is considered must-pass legislation.7,8 In previous cycles, PDUFA reauthorizations have presented an opportunity to pass other FDA-related policies, and this cycle is no different. On 26 May 2022, Senators Patty Murray (D-WA) and Richard Burr (R-NC) introduced PDUFA legislation that included several provisions related to dietary supplements, discussed below.9 While it is unclear at this point whether DSHEA reform ultimately will be passed in this year’s cycle, the prospect of a moving FDA legislative vehicle has sparked more focused attention to potential statutory changes regarding dietary supplements.
 
Second, the FDA’s food operations have recently received significant negative media and Congressional attention for allegedly lax oversight of a range of food safety issues.10-12 These criticisms include insufficient or inadequate inspections and a lack of oversight over potentially harmful constituents in food. Several proposals for DSHEA updates would increase FDA’s visibility into dietary supplement products on the market and boost inspections. Proponents believe these steps would increase FDA’s ability to target bad actors and enforce against unsafe products.
 
Below are key legislative updates for which the FDA, industry, and consumer groups have advocated. Proponents argue that these updates would close perceived loopholes in agency’s enforcement authority and update DSHEA to keep up with scientific and technological advances.
 
Mandatory product listing
Consumer groups, FDA, and many industry members support a mandatory product listing requirement for dietary supplements. Currently, drug and device manufacturers are required to “list” the drugs and devices they market when they register with the FDA.13 There is no such requirement for conventional foods or supplements.14 Manufacturers of foods and supplements describe the types of products manufactured when they register their production facilities with the agency, but there is no requirement to list the specific products sold.15
 
On 26 April 2022, US Senate Majority Whip Dick Durbin (D-IL) and Senator Mike Braun (R-IN) introduced the bipartisan Dietary Supplement Listing Act of 2022 (DSLA).16 The bill would create a new section of the Federal Food, Drug, and Cosmetic Act (FDCA) and of which DSHEA is a part, requiring responsible parties to submit a host of information about their dietary supplement products, including:
 
  • The brand and proprietary name of the dietary supplement,
  • An electronic copy of the dietary supplement label and any package insert,
  • A list of all ingredients and the amount of each ingredient per serving,
  • The conditions of use,
  • The warnings and precautions,
  • The presence of any major food allergens,
  • The dosage form, and
  • A list of health claims or structure/function claims.16
 
The bill would also require the FDA to create a unique dietary supplement identifier system, though it does not require the unique identifying number to appear on the product label.16 FDA would be tasked with maintaining a database with the unique identifier and product-listing information.16 Existing products that fail to list product information 60 days after the effective date (18 months after enactment) and products entering the market after the effective date that fail to list product information prior to distribution would be deemed misbranded.16
 
Senators Patty Murray (D-WA) and Richard Burr (R-NC) introduced PDUFA legislation on 26 May 2022, called the Food and Drug Administration Safety and Landmark Advancements Act of 2022 (FDASLA).9 FDASLA includes product listing requirements that largely mirror the DSLA. Two key differences are that FDASLA would not require product labels to be submitted, but it would require manufacturers to provide information about the quantity of ingredients in proprietary blends. FDASLA, as amended by the Senate Health, Education, Labor & Pensions Committee, also includes some confidentiality protections and an assurance that the bill does not grant the FDA authority to require premarket approval for supplements.17 Like the DSLA, a supplement would be deemed to be misbranded if it is not listed.9
 
The DSLA boasts support from many leading companies in the dietary supplement industry, as well as the largest US dietary supplement trade association, the Center for Responsible Nutrition.18 Industry, however, has largely opposed the listing provisions in FDASLA to date, arguing that they are overbroad and provide insufficient protection of confidential information.19
 
Critics of the bills also argue that they unnecessarily duplicate existing databases, including a widely used database hosted by the National Institutes of Health.20,21 Many supplement manufacturers have been voluntarily submitting product labels and other product information that would be required by the Dietary Supplement Listing Act into this database since its creation in 2013, and the database currently contains more than 136,000 supplement labels.22 The dietary supplement industry itself, spearheaded by the Council for Responsible Nutrition, established the Supplement OWL (Online Wellness Library) in 2017. The Supplement OWL is a self-regulatory tool that provides product labels and other information about tens of thousands of supplements to the public, with additional information accessible only to FDA, to help increase transparency in the marketplace.23
 
While there is no federal regulatory requirement to submit product listing information into these voluntary databases, critics argue that bad actors will not submit labels for the products most urgently needing FDA enforcement, even if required.20 Even so, the bill would make it an independent misbranding violation to fail to register, which gives FDA an easy tool for bringing enforcement.16
 
Another key criticism of the DSLA is that, apart from the new misbranding violation, it fails to increase the FDA’s enforcement authority to take unsafe products off the market.21 This criticism is discussed in the following section.
 
Closing the loophole in FDA enforcement authority
The director of the FDA Office of Dietary Supplement Programs (ODSP) has publicly taken the position that it lacks authority under the FDCA to remove certain illegal products from the market. Specifically, the ODSP has argued that it has authority only over dietary supplements. “Dietary supplement” is defined by the FDCA as a product that “bears or contains” one or more of five enumerated dietary ingredients – a vitamin, mineral, herb or botanical, amino acid, or dietary substance – for use by humans to supplement the diet by increasing the total dietary intake. It does “not include” an “article” (meaning an entity) approved or authorized for investigation as a new drug. If a product does not contain a “dietary ingredient” or includes an approved or investigational new drug, the FDA has said it does not have authority over it, even if it is marketed as a “dietary supplement” and bears a Supplement Facts label.4
 
Any product that represents itself to be a dietary supplement should be subject to the legal requirements that apply to dietary supplements. In technical assistance comments to Congress, the FDA has urged the creation of a new prohibited act for any product that is labeled as a dietary supplement but fails to meet the definition.24,25 The agency has also urged Congress to grant it authority to exclude imports and seize products that violated this provision.24,25 It recently reiterated the need for these amendments. President Biden’s FY2023 budget notes that the FDA seeks legislation to “clarify FDA’s authorities over products marketed as dietary supplements to facilitate enforcement against unlawfully marketed products.”26
 
Congress seems to have heeded FDA’s requests. If passed, FDASLA will make it a prohibited act to introduce or deliver for introduction into interstate commerce “any product marketed as a dietary supplement that does not meet the definition of a dietary supplement under [FDCA] section 201(ff).”9
 
FDA still has authority over “dietary supplements” that contain an ingredient that does not fall under the definition of a “dietary ingredient” when the supplement makes unlawful disease claims.27 And broader provisions of the FDCA would seem to give the FDA general authority to enforce against products represented (explicitly or implicitly) as dietary supplements but lacking dietary ingredients or containing drugs.
 
Nevertheless, legislation like the language proposed in FDASLA clarifying FDA’s authority to regulate products that purport to be “dietary supplements” as “dietary supplements” would give the FDA the assurance it needs to remove dangerous products from the marketplace. In addition, Congress could clarify that the agency also has authority over products that are not marketed with a dietary supplement statement of identity but that are intended to be used to supplement the diet. Faced with the FDA’s position that CBD cannot currently be marketed in supplements,28 some companies have elected to sell CBD in a form that mirrors common supplement forms (e.g., pill or tincture) but simply exclude a dietary supplement statement of identity. When such products do not make disease claims, similar uncertainty may arise about FDA’s jurisdiction over them. Such uncertainty could exist even if the proposed language in FDASLA were to be passed. Congress should pass legislation making clear that it does have authority over products that are intended to supplement the diet, even when the product does not call itself a dietary supplement.
 
Focus on the drug article exclusion
Dietary supplement companies that are marketing or are considering marketing a CBD supplement are likely familiar with FDCA Section 201(ff)(3)(B). This provision excludes from the definition of a dietary supplement any “article” approved as a new drug or authorized for investigation as a new drug or biological product for which “substantial clinical investigations” have been instituted and made public. An exception to this exclusion is if the article was “marketed as a dietary supplement or as a food” before the investigations were instituted or drug approved. Another exception is if the FDA, in its discretion, “has issued a regulation, after notice and comment, finding that the article would be lawful under [the FDCA].”29
 
Some aspects of this exclusion language have frustrated stakeholders in the dietary supplement industry over the years, and the issue has received much renewed attention given the recent focus on CBD, as well as the agency’s increasing use of this provision to exclude other ingredients. Each ingredient subject to the exclusion presents a new avenue for legislative interest.
 
Article excluded from definition of a dietary supplement
First, Congress could clarify the “article” that is excluded from use as a supplement. The seminal case on this issue is Pharmanex Inc. v. Shalala. Pharmanex marketed the dietary supplement Cholestin, which consisted of red yeast rice. Red yeast rice contains lovastatin, a natural cholesterol-inhibiting enzyme. The FDA had previously approved a cholesterol drug whose active ingredient was a synthesized, but chemically identical, version of lovastatin. FDA targeted Cholestin because Pharmanex selected a particular strain of red yeast fungus intended to produce lovastatin, manufactured the product to contain “significant amounts of lovastatin,” and specifically promoted Cholestin for its lovastatin content.30,31 The Tenth Circuit upheld FDA’s conclusion that Cholestin was not a dietary supplement because the synthesized version of lovastatin was the active ingredient in a drug approved before Cholestin was marketed.32
 
Under the Pharmanex case, the FDA interprets the “article” excluded as a drug to be both the finished drug product and its active ingredient. But even in the wake of case, the FDA continued to permit the marketing of red yeast rice supplements that contain lovastatin at levels consistent with those that naturally occur. Only when the red yeast rice supplement contains elevated lovastatin levels – and especially to levels approaching the dosage of FDA-approved drugs – has the agency taken enforcement action in relatively recent years.33
 
FDA has relied on 201(ff)(3)(B) to conclude that CBD may not be included in dietary supplements.28 Some dietary supplement manufacturers have asked FDA whether hemp extracts or oils containing CBD can be lawful, so long as the extract or oil is not manipulated to increase CBD content. The agency recently responded to two new dietary ingredient (NDI) submissions for full-spectrum hemp extracts. It took the position in both responses that the hemp extracts were barred by the drug article exclusion because they were manufactured to ensure consistent levels of CBD, provided “robust levels of CBD,” and were marketed as CBD products.34,35 The question remains whether a product containing lower levels of CBD that are not standardized or that does not highlight CBD in marketing would still be considered the same “article.”
 
There is also uncertainty regarding the circumstances under which an extract containing an excluded ingredient would be barred. Consider a situation where the ingredient is delivered in a different dosage form. The antioxidant N-acetyl-L-cysteine (NAC) was marketed as an inhaled drug for decades before being approved for oral use in 2016.36,37 Some industry stakeholders have argued that a supplement being delivered orally should not be considered the same “article” as an inhaled drug, and that different doses should similarly render a supplement different than an approved drug. The FDA has disputed these interpretations, but Congress could provide additional clarity on these questions to give industry greater certainty as to what substances can be lawfully marketed as dietary supplements.
 
Retroactivity of the drug preclusion
Another issue of recent debate is whether Congress intended the drug article exclusion provision to be retroactive. In other words, if a drug and supplement containing the same active/dietary ingredient were marketed before DSHEA, and the drug was approved before the supplement was marketed, did Congress intend DSHEA to preclude the continued marketing of the supplement?
 
This question came to a head in July 2020 when the FDA issued multiple warning letters asserting that a certain dietary ingredient marketed pre-DSHEA was barred by the drug exclusion language.38 This ingredient was NAC, a derivative of the naturally occurring amino acid L-cysteine. For decades, NAC has been marketed by numerous firms for its antioxidant and other nutritive properties.39 The FDA had considered NAC products and their marketing on numerous occasions, including in warning letters related to disease claims, structure/function claim notifications, and a qualified health claim petition, and had not clearly articulated the position that NAC was unlawful under the drug exclusion language.40-42 FDA has countered that it had on three occasions mentioned this position beginning in July 2001,43 but its position was not asserted consistently.
 
Nevertheless, the FDA firmly planted its stake in the ground in July 2020 when it issued four warning letters (primarily focused on drug claims) taking the position that NAC cannot be lawfully marketed as a supplement because NAC was approved as a new drug in 1963 and the agency is not aware of evidence that NAC was marketed as a supplement before that date.38,44-46 The earliest evidence the FDA has of NAC being marketed in a supplement or food dates back to 1991, before the passage of DSHEA but after new drug approval.43 Industry has argued that this interpretation violates a well-established canon of statutory interpretation that statutes should not be read to apply retroactively absent a clear, unambiguous intent to the contrary.47 The FDA’s position is that no retroactive conduct is being prohibited because only NAC marketed after DSHEA’s passage would be unlawful.43 Ultimately, the FDA denied citizen petitions from the Council for Responsible Nutrition and the Natural Products Association.43
 
The new twist in the NAC saga is that the FDA issued draft guidance on 21 April 2022 stating its intent to consider initiating rulemaking under section 201(ff)(3)(B) to permit the use of NAC in or as a dietary supplement.48 This would be the first time the agency has expressed its intent to initiate such a rulemaking. Unless it identifies safety-related concerns during the course of its ongoing review and rulemaking, the FDA intends to exercise enforcement discretion to allow NAC supplements to be marketed.49 This enforcement discretion will end either when the agency completes its notice-and-comment rulemaking or when it declines to initiate a rulemaking.49
 
While this enforcement discretion is a welcome respite for the many firms that market NAC supplements, it is far from a permanent solution and leaves open the possibility that FDA could take issue with other supplements lawfully marketed pre-DSHEA. Congress can take action to clarify that DSHEA’s drug exclusion was not meant to apply retroactively to supplements marketed pre-DSHEA but after the approval of a new drug. Doing so could help prevent another NAC-like circumstance, where the regulatory status of long-marketed supplements is suddenly called into question.
 
Determining an excluded article is lawful
A final point Congress could consider clarifying is under what conditions the FDA can authorize by regulation an article excluded for use as a supplement. The statute specifies that the agency can overrule the drug exclusion through notice-and-comment rulemaking “finding that the article would be lawful.”29 The FDA has not expressly interpreted this phrase, and similar language does not appear elsewhere in the FDCA. Before the aforementioned petitions related to NAC, the FDA had considered two petitions to find an excluded article to be “lawful” under FDCA 201(ff)(3)(B).50,51 The agency’s responses used relatively narrow language, suggesting that its authority was limited to finding an article was no longer excluded, not a finding that the article would otherwise be “lawful” under every other relevant provision of the FDCA.50,51 FDA guidance granting enforcement discretion to NAC supplements reveals that this determination will involve, at least in part, a review of relevant safety information.49 This leads to further questions about whether the agency can find NAC to be “lawful” in supplements only for certain intended uses or at certain doses. Congress can pass legislation to put in place reasonable guardrails for the FDA’s review.
 
Permitting CBD to be used in foods and supplements
When it comes to CBD, a number of stakeholders have clamored for legislation allowing the use of CBD in foods and supplements, while other stakeholders have cautioned that Congress should not meddle in scientific decisions best left to agency experts. Four years after stating it would consider the issue, the FDA has not changed its position that CBD is unlawful in foods and supplements. And it has escalated its stance against CBD-containing foods by stating that CBD is an unsafe food additive, requiring a food additive petition to be passed after notice-and-comment rulemaking, which means that CBD’s lawful use in food could be years away.52
 
Multiple bills have been introduced that would permit the use of CBD in foods and supplements. The Hemp Access and Consumer Safety Act would do so by simply inserting the parenthetical “(other than hemp, hemp-derived cannabidiol, or a substance containing any other ingredient derived from hemp)” into FDCA section 201(ff)(3)(B) and the corresponding provision for food – FDCA section 301(ll).53,54 Another proposal, the Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act, would permit CBD to be used in foods and supplements but expressly requires that such use in dietary supplements comply with NDI notification procedures.55,56 While these bills have been introduced, they have received little attention by the committees of jurisdiction for FDA issues, and key committee staff have commented publicly that these are decisions best left for FDA.
 
An NDI notification is required for dietary ingredients marketed on or after 15 October 1994.57 In general, NDIs must be the subject of a notification to FDA with the basis for the manufacturer’s safety determination 75 days before marketing a supplement containing the ingredient in the US. NDIs are exempt from the NDI notification requirement if they “have been present in the food supply as an article used for food in a form in which the food has not been chemically altered.”57 Industry lists of pre-DSHEA (or “old”) dietary ingredients marketed before 15 October 1994 do include “cannabis sativa.”58 However, they do not specify what part of the plant was used.58 Under the FDA’s revised draft NDI notification guidance, the agency has taken a broad interpretation of the types of changes that would alter the identity of the dietary ingredient, thereby turning an “old” dietary ingredient into a “new” one.59 Such changes include extracting material from a different part of the plant or changing the manufacturing in a way that alters the serving level or conditions of use.59
 
The FDA will likely take the position that CBD needs to be the subject of an NDI notification. A notification would not be required if CBD was used in food before its sale as a dietary supplement, and was not chemically altered when used in supplements.57 However, the agency would likely say that CBD was not lawfully marketed in food before sale as a supplement and it takes a broad view of what constitutes a “chemical alteration.”59 The FDA expects to issue final guidance on NDI notifications by the end of 2022, according to its priority guidance list, so the agency’s interpretation of NDI notification requirements may change.60 
 
In summary, even if legislation that explicitly permits the use of CBD and other hemp-derived materials in supplements passes, although it seems unlikely, the FDA may require such substances to be the subject of NDI notifications (if the chemically identical substance was not first used in food). NDI notifications are significant undertakings for industry and historically have had a low success rate.61 Thus, even if Congress passes some legislation aimed at advancing the FDA’s consideration of the use of CBD in food and supplements, industry could still face significant hurdles to lawful marketing of these products.
 
Third-party inspections for supplement facilities
The FDA’s inspection of dietary supplement facilities has lagged below its inspection rates for other FDA-regulated product categories. Before the pandemic, only 5% of operating supplement firms were inspected each year and many of those were repeat inspections, meaning there were even fewer original inspections.4 In addition, supplement inspections have a higher rate of failure than inspections of other FDA-regulated products, with frequent deficiencies in fundamental requirements like establishing specifications and testing to make sure that ingredients and products meet those specifications.4 (This may be due, in part, to the FDA’s lack of guidance to industry on dietary supplement current good manufacturing practice (cGMP) regulations.)
 
There is significant industry support for a proposal to supplement inspections by FDA personnel with inspections conducted by private, third-party auditors. Such auditors would be accredited by the FDA to ensure facilities meet the agency’s cGMP standards for dietary supplements. Either the FDA or the facility could request a third-party audit, and the cost of inspection could be borne by the requesting party. Under the proposal, the agency would develop criteria whereby third parties could be accredited and would publish a list of accredited auditors.
 
This type of third-party arrangement has precedent under FDA regulations. In 2002, Congress passed a law requiring FDA to accredit third parties to perform inspections of eligible manufacturers for Class II or Class III medical devices (meaning moderate and higher-risk devices).62 This program is voluntary, so agency cannot unilaterally elect for an inspection to be conducted by a third party. Moreover, the list of FDA-accredited bodies is quite short – the FDA’s website currently lists only five, and each is permitted to operate in only one country.63 As a result, the FDA’s third-party auditing program for medical devices has historically resulted in low participation. A 2008 Government Accountability Office report found that in the four years following the program’s launch in 2004, only four inspections of foreign establishments were conducted by accredited organizations.64 Congress changed eligibility requirements in 2007 to increase participation,65 but the program remains underused and eventually was eclipsed by another inspection program.
 
Congress should consider the successes and failures of the medical device program if it proposes a similar program for dietary supplements. If such legislation proceeds, the FDA should deputize ample third parties to maximize participation and should consider other incentives for voluntary industry participation. Legislative language for a third-party inspection program has not yet been proposed. FDASLA requests that the FDA prioritize inspections for “dietary supplement types that present a high risk to public health,” but the bill did not propose a third-party program.9
 
Scientific literature
Finally, Congress can consider updating DSHEA’s provisions governing the distribution of truthful scientific information about the benefits of dietary supplements. FDCA section 403B is intended to provide safe harbor for supplement companies that want to publish truthful scientific information about their products. This section provides that publications are not considered “labeling” subject to the FDA’s misbranding provisions when scientific information
 
  • Is reprinted in its entirety,
  • Is not false or misleading,
  • Does not promote a particular manufacturer or brand of a dietary supplement,
  • Presents a balanced view of the available scientific information,
  • Is physically separate from the dietary supplements, if displayed in an establishment, and
  • Does not have appended to it any information by sticker or any other method.66
 
Since DSHEA’s passage in 1994, online marketing has taken over traditional retail. The physical separation criteria can be difficult for manufacturers to navigate in an online context. One consideration is whether studies should be provided on a separate website not obviously affiliated with the brand or whether they can be shared on the brand’s main site or social media. Congress could update this section to reflect today’s online marketplace.
 
Conclusion
The FDA, consumers, NGOs, and industry generally agree that DSHEA is in need of an update. While the seminal legislation was critical for consumers and in helping the supplement industry flourish, it has not kept pace with changes in technology and realities of the digital marketplace. Stakeholders have proposed a number of reforms, from product listing to permitting the use of CBD from hemp in foods and supplements. PDUFA has historically been an important legislative vehicle for a variety of FDA-related proposals, and even though those were mostly focused on medical products in the past, dietary supplement reforms are getting serious attention by Congress right now. Even if DSHEA reforms do not pass in this round of PDUFA, the potential legislative vehicle has prompted stakeholders to concretize their proposals. In addition, media and Congressional critiques of the agency’s regulation of foods may fuel proposals that would increase FDA’s ability to oversee and inspect supplement establishments. Given these factors, it seems that DSHEA reform may be on the horizon.
 
 
Abbreviations
DSHEA, Dietary Supplement Health and Education Act; FDA, [US] Food and Drug Administration; CBD, cannabidiol; NGOs, nongovernmental organizations; PDUFA, Prescription Drug User Fee Act; FDCA, Federal Food, Drug, and Cosmetic Act; FDASLA, Food and Drug Administration Safety and Landmark Advancements Act; DSLA, Dietary Supplement Labeling Act; ODSP, [FDA] Office of Dietary Supplement Programs; NAC, n-acetyl-L-cysteine; cGMP, current good manufacturing practice; NDI, new dietary ingredient.
 
About the authors
Krista Hekking, JD, is a 4th-year associate at Covington & Burling LLP, specializing in food regulatory matters. She provides strategic advice to conventional food, dietary supplement, medical food, and infant formula companies on a range of FDA compliance issues and related litigation risks. Hekking holds a JD from the University of Virginia School of Law. She can be reached at KHekking@cov.com
 
Miriam Guggenheim, JD, is a partner at Covington & Burling LLP and co-chair and Covington’s Food, Drug and Device Practice Group. She assists a range of major food and dietary supplement companies in achieving their marketing goals while minimizing regulatory and litigation risks and in navigating recalls and unwanted Congressional or regulatory attention. Guggenheim holds a JD from Columbia Law School. She can be reached at MGuggenheim@cov.com
 
Citation Hekking K, Guggenheim M. Proposed updates hint at dietary supplement legislative reform. Regulatory Focus. Published online 30 June 2022.
 
References
All references accessed/verified 30 June 2022.
 
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  14. 21 CFR pt. 1, subpt. H.
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  27. FDCA §§ 201(g)(1), 201(p), 505(a).
  28. Food and Drug Administration. FDA regulation of cannabis and cannabis-derived products, including cannabidiol (CBD). https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd#dietarysupplements. Updated 22 Jan. 2021.
  29. FDCA § 201(ff)(3)(B).
  30. Pharmanex, Inc. v. Shalala, 35 F. Supp. 2d 1341, 1346 (D. Utah 1999).
  31. Pharmanex, Inc., v. Shalala, No. 2:97CV262K, 2001 WL 741419, at *3 (D. Utah 30 March 2001).
  32. Pharmanex, Inc. v. Shalala, 221 F.3d 1151, 1160 (10th Cir. 2000).
  33. Dixon RP, Food and Drug Administration. Warning letter to IP-6 Int’l. 23 April 2014.
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  36. Food and Drug Administration. Drugs@FDA:FDA approved drugs, Mucomyst. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=013601 (identifying Mucomyst’s dosage form as “solution; inhalation, oral”)
  37. Korvick J. Food and Drug Administration. Letter to Arbor Pharmaceuticals, LLC. Dated 29 January 2016. (approving Cetylev (acetylcysteine) effervescent tablets for oral solution), https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207916Orig1s000ltr.pdf
  38. Correll WA, Food and Drug Administration. Warning letter to Purple Biosciences, LLC. Dated 23 July 2020, https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/purple-biosciences-llc-593772-07232020
  39. Office of Dietary Supplements, National Institutes of Health. N-acetyl cysteine. https://dsld.od.nih.gov/search/N-acetyl%20cysteine/bWFya2V0X3N0YXR1cz1hbGwvZW50cnlfZGF0ZT0yMDExLDIwMjEvc29ydD1tYXRjaC9wYWdlX3NpemU9MjAv  
  40. Correll WA. Food and Drug Administration. Warning letter to John Gray’s Mars Venus LLC. Dated 5 Feb. 2019 https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/john-grays-mars-venus-llc-564498-02052019
  41. Moore RJ. Food and Drug Administration. Courtesy letter to LES Labs, Inc. Dated 14 Apr. 2010, https://www.regulations.gov/document/FDA-1997-S-0006-1087.
  42. Balentine D. Food and Drug Administration. Response to qualified health claim petition to Thomas B. Shea, Sevo Nutraceuticals, Inc. Dated Dec. 12, 2018. https://www.regulations.gov/document/FDA-2016-Q-1523-0158
  43. Stearn DW. Food and Drug Administration. Letter to Steve Mister & Megan Olsen, Council for Responsible Nutrition, & Daniel Fabricant, Nat’l Prods. Ass’n. Dated 31 March 2022. https://www.regulations.gov/document/FDA-2021-P-0523-0022 (providing final response to citizen petitions)
  44. Correll WA. Food and Drug Administration. Warning letter to LES Labs. Dated 23 July 2020. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/les-labs-593764-07232020
  45. Correll WA, Food and Drug Administration. Warning letter to Vita Heaven, LLC. Dated 23 July 2020. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/vita-heaven-llc-dba-hangover-heaven-593765-07232020
  46. Correll WA. Food and Drug Administration. Warning letter to Happy Hour Vitamins. Dated 23 July 2020. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/happy-hour-vitamins-593770-07232020
  47. Council for Responsible Nutrition. Citizen petition, p. 6. Dated 1 June 2021. https://www.regulations.gov/document/FDA-2021-P-0523-0001
  48. Food and Drug Administration. FDA releases draft guidance on enforcement discretion for certain NAC products. Dated 21 April 2022. https://www.fda.gov/food/cfsan-constituent-updates/fda-releases-draft-guidance-enforcement-discretion-certain-nac-products
  49. Food and Drug Administration. Policy regarding N-acetyl-L-cysteine: Guidance for industry, draft guidance. Dated April 2022. https://www.fda.gov/media/157784/download
  50. Landa MM. Acting Director, Center for Food Safety and Applied Nutrition. Letter to Marc S. Ullman, Ullman, Shapiro & Ullman, LLP, Counsel for OVOS Natural Health Inc. Dated 23 February 2011. https://www.regulations.gov/document/FDA-2009-P-0298-0008
  51. Tave SJ. Director, Office of Dietary Supplement Programs, Food and Drug Administration. Interim response letter to J. Wesley Fox, Dir. of Regulatory Affairs/Bus. Dev., ViGuard Health Inc. Dated 25 Apr 2018. https://www.regulations.gov/document/FDA-2017-P-6245-0009 
  52. Ashley DD. Food and Drug Administration, et al. Warning letter to MB Solutions, LLC/BioSpectrum CBD. Dated 22 July 2021. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mb-solutions-llcbiospectrum-cbd-610649-07222021
  53. S. 1698, 117th Cong. 2021. https://www.congress.gov/117/bills/s1698/BILLS-117s1698is.pdf
  54. HR 5587, 116th Cong. 2020. https://www.congress.gov/116/bills/hr5587/BILLS-116hr5587ih.pdf
  55. HR 841, 117th Cong. 2021. https://www.congress.gov/117/bills/hr841/BILLS-117hr841ih.pdf
  56. HR 8179, 116th Cong. 2020. https://www.congress.gov/116/bills/hr8179/BILLS-116hr8179ih.pdf
  57. FDCA § 413.
  58. United Natural Products Alliance. Old dietary ingredient list. (1999).
  59. Food and Drug Administration. Dietary supplements: New dietary ingredient notifications and related issues: Guidance for industry, draft guidance. Published August 2016. https://www.fda.gov/media/99538/download.
  60. Food and Drug Administration. Food programs guidance under development. https://www.fda.gov/food/guidance-documents-regulatory-information-topic-food-and-dietary-supplements/foods-program-guidance-under-development. Updated 30 June 2022.
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  62. Medical Device User Fee and Modernization Act of 2002, Pub. L. No. 107-250, 116 Stat. 1588 (2002), https://www.govinfo.gov/content/pkg/STATUTE-116/pdf/STATUTE-116-Pg1588.pdf
  63. Food and Drug Administration. Inspection by accredited persons program. https://www.fda.gov/medical-devices/third-party-inspection-devices/inspection-accredited-persons-program. Updated 27 May 2021.
  64. US Government Accountability Office. GAO-08-780T, Medical devices: FDA faces challenges in conducting inspections of foreign manufacturing establishments. Published 14 May 2008. https://www.gao.gov/products/gao-08-780t
  65. Food and Drug Administration Amendments Act of 2007, Pub. L. No. 110-85, 121 Stat. 823 (2007). https://www.govinfo.gov/content/pkg/PLAW-110publ85/pdf/PLAW-110publ85.pdf
  66. FDCA § 403B.
 
 
 

 

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