MPL Budget Request Op Ed
March 12, 2024
Daniel Fabricant, Ph.D., President and CEO of NPA
Another year, another FDA attempt to impose pre-market approval for dietary supplements.
Once again, the President’s budget proposal for fiscal year 2025 calls for Congress to pass the agency’s “mandatory product listing” (MPL) proposal.
Once again, I’m confident certain industry cheerleaders will applaud this misguided idea, as they have in the past.
Once again, I am urging our industry not to be fooled into thinking that this is anything other than pre-market approval by another name—and if you don’t believe me, believe what the FDA is trying to engineer behind the scenes.
Allow me to explain what I mean by that.
NPA collaborated with our champions in the House and Senate in 2022 to knock MPL out of the original Senate legislative package to reauthorize the FDA’s various user-fee programs despite the fanatical support for MPL from certain industry organizations. During that debate, those organizations accused NPA of spreading misinformation about the true nature of MPL. They tried to suggest that neither the FDA nor Congress were seeking authority to require pre-market approval of dietary supplements.
We continue to disagree on what the language in the proposal would have accomplished. But there can be no doubt about the FDA’s true intent, based on new information that has recently come to light.
A recent Freedom of Information Act request has uncovered a document authored by FDA officials to provide “technical assistance” to the legislative drafters of the MPL proposal.
In that document, the FDA asked Congress to give the agency the authority to establish a “unique dietary supplement identifier system.” The language requested by the FDA would have demanded that “the label of each dietary supplement shall contain the unique dietary supplement identifier assigned by the Secretary.” Moreover, this requirement would have applied to existing supplements already on the market, not just new products—and without any deadline for the FDA to approve a submission and assign said identifier.
In other words, if the FDA had its way, no dietary supplement could be marketed without the agency granting a “unique dietary supplement identifier” at its discretion and on its own timeline.
How is that not a form of pre-market approval?
To be fair, the Senate drafters were smart enough to know that this proposal was too brazen. They no doubt told FDA officials to bide their time and wait for a better opportunity to insert the “unique dietary supplement identifier” into law. But now that this language has seen the light of day, there can no longer be any doubt about the FDA’s ultimate aim.
Giving the FDA an administrative excuse to reject ingredients from being marketed as dietary supplements without any regard for the science or history is a non-starter. A bipartisan Congress understood that in 2022. It’s long past time for the FDA and certain industry organizations to end their shared MPL crusade once and for all.
Go to the Natural Products Association’s website and click to act. Tell Congress “NO” on MPL for FDA.
hEmpire Building
May 9, 2023
Daniel Fabricant, Ph.D., President and CEO of NPA
On Thursday, FDA will tell us about their “new pathway” for hemp/CBD and other cannabinoids. The only botanical currently exempted as a food/dietary supplement is tobacco. But the FDA will propose a new pathway or Center that would take CBD/Cannabinoids out of the world of food/dietary supplements, drugs, and risk-benefit analysis, which is the basis for the FDA. The implications for other things in the dietary supplement and food space are where this could be very problematic. Generally, when you think about the FFDCA, no risk: benefit means little to no ability to make claims.
FDA will say their concerns are contaminants – but cGMPs can currently deal with those – they haven’t inspected facilities to cGMP to see what controls are being used to control THC and other contaminants.
FDA will say their concerns are establishing a content limit – they can do that now via the NDI or GRAS processes and just basic scientific principles- they haven’t done that. However, they like to mention that using food to administer CBD will result in overuse and consumption. Since when does the agency regulate food misuse or abuse? “kid, put down that second can of soda. Your blood sugar is spiking.”
FDA will say there’s a need for clear labeling – other botanicals are clearly labeled – including some currently with age and cautionary demographic statements (i.e., not to be used by children or not to be used by pregnant, expecting mothers) where appropriate.
The FDA will want a new center to lump in topicals, combustion products, non-combustion inhaled, and ingestible products. Who knows, they may even try to throw animal feed in. “We can’t have the children or the animals at risk of CBD exposure,” will say the agency that has let thousands of products come to market since 2018.
FDA took extra money from congress to come up with a way forward using existing pathways to regulate CBD as a food or dietary supplement (https://www.congress.gov/bill/116th-congress/house-bill/1158) “it directed $2 million to the FDA for research, policy evaluation, market surveillance, and issuance of an enforcement discretion policy and appropriate regulatory activity” for hemp-derived CBD. This appropriation further required the FDA to produce a report on its progress toward obtaining and analyzing data to help determine (1) a policy of enforcement discretion and (2) a process in which hemp-derived CBD will be evaluated for use in products) now they want to come up with a new pathway by people, which may have expertise in hemp but people who don’t understand the act and have never administered the act to protect public health.
These people want to spend hundreds of millions and take at least a decade to depart from scientific principles that are already in place in the statutes and CFR. The agency could have developed a NOAEL for CBD, which could have been done and has been done by other governments; FDA could have written a drug exclusion regulation or set a policy of enforcement discretion via guidance; FDA could have reviewed data on a company-by-company basis for safety, several which are at the OECD level of safety assessment; the agency could have inspected facilities and done random testing to see how contaminants are being controlled. Instead, FDA did none of those things central to its mission, especially to establish a daily amount that people want to know above all else.
In this announcement, the priority is on state/local government officials as more important “stakeholders” than, you know, farmers, manufacturers, retailers, and Americans who want their tax dollars spent on strategies and real action under current laws. Hence, they know what they can use now so that some government officials can take credit for “a new pathway.” The road works, but if the government doesn’t take it, why the need to build a new one?
The question remains, will people fall for it? With many advocates between two minds, one of being able to say they created something new or were a part of something new versus being able to move forward quickly and effectively under current circumstances, we’ll know quickly if receiving the credit on this is more important than addressing the unnecessary challenges the government has created to stall and delay a stabilized marketplace.
One issue that won’t be resolved by proposing a new center/path for cannabinoids is the exclusion criteria for dietary supplements. Since 1994 the agency has had the power to use the authority to write a regulation to start to clarify the exclusion and when it is appropriate to use, under the premise that dissenters can have an opportunity to be heard via notice and comment rulemaking. Two things are clear: twenty-nine years have gone by, and the agency is not going to write a regulation on that part of the law to create a pathway unless the judicial branch intervenes; and ironic that many refer to it as a “race to market” clause, as is the case for CBD, and likely for future cannabinoids it will be wielded as a tool to slow down the race to a crawl for one side.
NMN, NAC and How to Make an Impact
April 13, 2023
Daniel Fabricant, Ph.D., President and CEO of NPA
Last year, the FDA announced it would exercise enforcement discretion, including no restrictions on daily amounts of NAC, thanks to NPA’s Citizen’s Petition and lawsuit. But while the announcement of enforcement discretion was a major victory for the industry, unfortunately, the agency has continued to interpret the law inappropriately. As we have seen, beta-nicotinamide mononucleotide (NMN) can apparently not be in dietary supplements due to its earlier investigation as a pharmaceutical drug While we only filed our CP with ANH about a month ago on NMN, many want to do their part to join the fight. First and foremost, become a member of the NPA. Since 1936 we’ve been fighting for the right of the industry to exist. While that may sound intense, if you look at the history of NPA, it’s easy to see even with recent events in the states like Colorado, the world of Natural Products without the Natural Products Association in the fight gets pretty grim.
For more about membership, reach out to Felix Kang or Stephen Sullivan at fkang@npanational.org or ssullivan@npanational.org.
In the meanwhile, send your lawmakers a note on NMN through our grassroots campaign and register for our fly-in day on Wednesday, June 7, here.
Maintaining Health and Wellness and the IRS?
April 10, 2023
Kyle Turk, Government Affairs
Today, the NPA board sent a letter to the IRS on adding dietary supplements to allow for reimbursement of certain dietary supplement expenditures. We’ve asked before, with some help from our friends, here and here. However, that ask was before COVID relief packages added OTC drugs and some feminine hygiene products as necessary medical expenses. There is no reason to think that vitamin D and other dietary ingredients shouldn’t fit there. Consumers shouldn’t need a prescription or a co-pay to access such products on a health savings or flex spending account. This is a big part of why Reps. Darin LaHood and Brendan Boyle of the Ways and Means Committee (the committee of jurisdiction) introduced legislation last Congress to allow for such preventative health costs to be tax-deferred. Whether it is the Administration’s or Congress’ interest in promoting disease prevention, health care choice, and competition, all would be advanced by modernizing the treatment of “nutritional supplements” under the Internal Revenue Code(IRC). The IRS could accomplish this by revising IRS Publication 502 to allow nutritional and dietary supplements that carry health claims or structure/function claims to be considered “medical expenses.”
This change would allow Americans to choose to be reimbursed from their HRAs, HSAs, or FSAs for the out-of-pocket costs they pay for nutritional and dietary supplements — a meaningful way for the government to promote consumer choice and better health.
Background on IRS treatment of our industry
Section 262 of the IRC states that no deduction shall be allowed for personal, living, or family expenses except as otherwise expressly provided.
One prominent exception to this prohibition lies in Section 213(a) of the IRC, enacted in 1954, which allows a deduction for expenses paid during the taxable year, not compensated for by insurance or otherwise, for the medical care of the taxpayer, the taxpayer’s spouse, and the taxpayer’s dependents.
Section 213(d) provides, in turn, that the term “medical care” includes “amounts paid for the diagnosis, cure, mitigation, treatment, or prevention of disease, or for the purpose of affecting any structure or function of the body.”
However, Section 1.213-1(e)(1)(ii) of the Income Tax Regulations, promulgated in 1960, seeks to limit the scope of the statutory definition by stating that “deductions for expenditures for medical care allowable under section 213 will be confined strictly to expenses incurred primarily for the prevention or alleviation of a physical or mental defect or illness,” and stating that “an expenditure which is merely beneficial to the general health of an individual, such as an expenditure for a vacation, is not an expenditure for medical care.”
IRS Publication 502, as revised for the tax year 2000, included for the first time a specific exclusion of “nutritional supplements” from the definition of “medical expenses,” stating that:
“You can’t include in medical expenses the cost of nutritional supplements, vitamins, herbal supplements, ‘natural medicines,’ etc. unless they are recommended by a medical practitioner as treatment for a specific medical condition diagnosed by a physician. These items are taken to maintain your health and aren’t for medical care.”
Background on FDA regulation of “dietary supplements”
The FDA regulates dietary supplements (nutritional supplements in IRS parlance) under several laws, including the Nutrition Labeling and Education Act of 1990 (NLEA) and the Dietary Supplement Health and Education Act of 1994.
Dietary supplements are defined, in part, as products intended to supplement the diet that bears or contain one or more of the following dietary ingredients: a vitamin; a mineral; an herb or other botanical; an amino acid; a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or a combination of any ingredient mentioned above. Further, dietary supplements are products intended for ingestion, are not represented for use as a conventional food or as a sole item of a meal or the diet, and are labeled as dietary supplements.
By law, manufacturers may make three types of claims for their dietary supplement products: health claims, structure/function claims, and nutrient content claims.
Health claims describe a relationship between foods and dietary supplements and reduced risk of a disease or health-related condition. Health claims are subject to premarket review and authorization by FDA. There are three ways in which FDA exercises its oversight in determining which health claims may be used on a label or in labeling for a food or dietary supplement:
The 1990 Nutrition Labeling and Education Act (NLEA) provides for FDA to issue regulations (which were finalized in January 2003) authorizing health claims for foods and dietary supplements after reviewing and evaluating the scientific evidence, either in response to a health claim petition or on its initiative;
The 1997 Food and Drug Administration Modernization Act (FDAMA) provides for health claims based on an authoritative statement of the National Academy of Sciences or a scientific body of the U.S. government with responsibility for public health protection or nutrition research; such claims may be used 120 days after a health claim notification has been submitted to FDA unless the agency has informed the notifier that the notification does not include all the required information; and
As described in the FDA’s guidance entitled Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements, the agency reviews petitions for qualified health claims where the quality and strength of the scientific evidence falls below that required for FDA to issue an authorizing regulation. If FDA finds that the evidence supporting the proposed claim is credible and the claim can be qualified to prevent it from misleading consumers, the agency issues a letter of enforcement discretion specifying the qualifying language that should accompany the claim and describing the circumstances under which it intends to exercise enforcement discretion for the use of the claim in food labeling.
Structure/function claims may describe the role of a nutrient or dietary ingredient intended to affect the normal structure or function of the human body. For example, “calcium builds strong bones.” In addition, they may characterize how a nutrient or dietary ingredient maintains such structure or function, for example, “fiber maintains bowel regularity” or “antioxidants maintain cell integrity.”
The Dietary Supplement Health and Education Act of 1994 (DSHEA) established some special regulatory requirements and procedures for using structure/function claims. Structure/function claims are not subject to FDA pre-approval. Still, manufacturers must have substantiation that such claims are truthful and not misleading, must state in a disclaimer that FDA has not evaluated the claim, and must also state that the dietary supplement product is not intended to “diagnose, treat, cure or prevent any disease,” because only a drug can legally make such a claim. The regulatory requirements for structure/function claims were published as a final rule in January 2000, with follow-on guidance for the industry issued in January 2002.
Nutrient content claims describe the level of a nutrient in the product, using terms such as free, high, and low, or they compare the level of a nutrient in a food to that of another, using terms such as more, reduced, and lite. The Nutrition Labeling and Education Act of 1990 (NLEA) permits using these claims.
Modernize IRS treatment of dietary supplements.
As noted earlier, the IRC defined “medical care” in 1954 as “amounts paid for the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect any structure or function of the body.”
The Natural Products Association believes that two of the three types of dietary supplement claims fit this definition:
Health claims — under the 1990 Nutrition Labeling and Education Act, nutritional and dietary supplements may carry health claims regarding the reduced risk of disease under certain circumstances. Nutritional or dietary supplements making such claims should be covered by the “prevention of disease” section of the IRC’s “medical care” definition.
Structure/function claims — under the 1994 Dietary Supplement Health and Education Act, nutritional or dietary supplements are permitted to carry structure/function claims, which should fit into the “affecting any structure or function of the body” section of the definition.
Nutrient content claims, on the other hand, do not appear to fit into the IRC “medical care” definition, and we are not proposing to include this third type of claim at this time.
We acknowledge that the 1960 regulation seeks to confine “medical expenses” strictly to those expenses “incurred primarily for the prevention or alleviation of a physical or mental defect or illness” and to exclude expenditures on items or services that are “merely beneficial to the general health of an individual.”
However, we believe that IRS would not need to change this regulation to accommodate our proposal. For dietary supplements that carry structure/function claims, there is a clear and direct line to Section 213(d) of the IRC, which speaks to “amounts paid….for the purpose of affecting any structure or function of the body.”
As for health claims, Congress acted in 1994 to allow dietary supplements to carry claims that relate to reduced risk of a disease or health-related condition, and we would argue that expenses for this category of supplements are clearly incurred “for the prevention or alleviation of a physical or mental defect or illness” as required under the 1960 regulation.
Tax laws and regulations from the 1950s and 1960s could not anticipate how important and popular nutritional supplements would become in the 21st century, and the 2000 update to IRS Publication 502 did not contemplate many of the changes in dietary supplement regulation that were happening around the same time at the FDA.
IRS should revise Publication 502 for tax years 2024 and beyond to read as follows:
“You can include in medical expenses the cost of nutritional supplements, vitamins, herbal supplements, ‘natural medicines,’ etc., provided that such products are labeled with a health claim authorized by the Food and Drug Administration, bear statements describing how they are intended to affect the structure or function of the human body, or bear statements characterizing the documented mechanism by which the product acts to maintain such structure or function.”
This would modernize the treatment of supplements for the deduction of out-of-pocket medical expenses and purposes of reimbursable expenses from HRA, HSA, and FSA accounts.
CBD and Intoxicating Hemp Constituents – Implications for Dietary Supplements and Foods?
April 6, 2023
Daniel Fabricant, Ph.D., President and CEO of NPA
I just got back from the NoCo hemp expo last week, thanks to Morris Beegle and was fortunate enough to be on a panel there with some terrific folks to discuss FDA pathways on CBD. By fortunate coincidence, and thanks to Gillian Schauer and all the good folks at CANNRA for organizing a Trade Association panel yesterday on various Hemp topics. One issue that keeps coming up is the subject of “intoxicating.” The issue of intoxication is not new in terms of the FDA. If we go to the Structure/Function Final Rule on page 16, question 38, the agency gives its piece on the matter:
“….A few comments argued that alcohol intoxication is a ‘‘self-induced condition’’ and not a disease. FDA continues to believe that alcohol intoxication, like all poisonings (mushroom, digitalis, or any drug overdose), meets the definition of disease, albeit a transient disease. The definition in § 101.14(a)(5), which FDA is incorporating in this rule, states, in part, that a disease is ‘‘damage to an organ, part or structure, or system of the body such that it does not function properly * * *’’ All poisonings, like alcohol intoxication, cause dose-related dysfunctioning and damage, ranging from mild impairments to death. Alcohol intoxication causes temporary damage to brain function, causing impairments of judgment, attention, reflexes, and coordination. The fact that it is ‘‘self-induced’’ does not remove it from the definition of disease. Deliberate barbiturate overdoses are also self-induced, but clearly meet the definition of disease.”
While the discussion in the final rule is not specific to hemp/cannabinoids, and I’m not attributing or debating AERs or the “damage or dysfunction” caused by hemp/cannabinoids, still, the construct for foods and dietary supplements to make claims doesn’t appear to allow the inclusion of intoxication in the marketplace. This is an important consideration as many are looking at ways to ensure CBD and other cannabinoids going forward have a clear path to market under the FFDCA.
The Cold Hard Truth About Mandatory Product Listing
April 18, 2022
Kyle Turk
I recently came across a blog post that attacks the Natural Products Association’s (NPA) long-standing opposition to “mandatory product listing” or “MPL.” The post from an industry association executive suggested NPA was making “strawman arguments” and using a “dog whistle” to alarm the industry.
As I will illustrate, MPL is the logical first step toward premarket approval for dietary supplements, and we aren’t using a dog whistle to call this out: we’re using the megaphone we’ve earned as the nation’s longest-standing association for our industry and the strong convictions of our members who see this proposal for what it is, not what proponents think it is.
To defend this new unfunded mandate on industry and FDA, this association executive tries to pass off MPL as “comparable to a birth certificate, not a driver’s license.” He argues this means that “FDA would be required to accept any label presented for the inclusion in the registry, in the same way a local health authority cannot refuse to issue a birth certificate.”
This is a nonsensical metaphor. I’m not a parent, but even I know that parents don’t simply present information about their newborn to the government and receive a birth certificate. A physician or midwife certifies a birth to the local government authority, which then issues the birth certificate to the parents. Governments don’t simply accept an application from parents without evidence of and detailed specifics about the birth, just like FDA just doesn’t “take our word for it” when it comes to its regulatory authorities.
What’s even worse than the bad metaphor is the lack of vision this executive displays. Remember that his argument is that “FDA would be required to accept any label” and will have “visibility into the market (to) find those illegal ingredients and labels.”
First of all, on what planet is someone going to submit an illegal label with illegal ingredients to a regulatory body?
But for the sake of fully exposing this concept, let’s envision a future in which FDA creates a registry that includes all dietary supplement labels, some of which are false and misleading or are for products FDA doesn’t recognize as supplements. In short order, FDA would inevitably return to Congress with the argument that “It’s untenable for FDA to maintain a labeling database that includes every label we receive, false and misleading or otherwise. This is confusing to consumers, so please give FDA the authority to review the labels before we include them in the database.”
And once that happens, FDA will have the authority to review and approve a label before a product comes to market.
In other words, FDA will have premarket approval authority over dietary supplements.
We at NPA can see where MPL leads, even if others can’t. We also recognize and understand the various laws that govern our industry, including mandatory facility registration, which allows the Agency to know what companies exist in the market and where they are located.
FDA has the tools it needs to find the bad actors – what it lacks is the will, as evidenced most recently by the Politico expose of regulatory failures at the Center for Food Safety and Applied Nutrition.
CFSAN obviously has plenty of work to do without the additional imposition of an unenforceable and pointless new mandate like MPL on them. It’s time for certain organizations to move past the distraction of MPL and work with us and with Congress on a regulatory agenda that meets the real needs of the industry and our consumers, with the resources FDA needs to carry that agenda out.
FDA’s Authority, the NDI Process, and CBD
March 23, 2021
Daniel S. Fabricant, Ph.D.
Across the country, things are beginning to feel like they are getting back to normal. It certainly feels like business as usual in Washington, DC, especially for the multi-billion-dollar CBD marketplace and the Food and Drug Administration’s (FDA) failure to create a regulatory pathway for it.
For more than four years, the Natural Products Association (NPA) has been asking the FDA to set a safe level of daily consumption for CBD products. Instead of taking real substantive action, the FDA has slapped a few companies on the wrist for making false claims, while leaving the bulk of the regulatory work to the states, with 24 states introducing proposals to regulate the CBD industry’s manufacturing, testing, and labeling of products at the state level.
While many states have stepped up where the feds have fallen short, that has not stopped proposals in Congress from moving forward that would do more harm than good when it comes to safely regulating CBD.
One proposal supported by some industry groups, including the Council for Responsible Nutrition (CRN) would play right into the hands of critics who wrongfully claim that the dietary supplement industry is unregulated.
While CRN claims to be moving CBD legislation, the truth is that this bill lacks the support of House and Senate leaders who are concerned about undermining the authority of DSHEA and FDA.
The proposal, called the Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act (HR 841) would create an end-run around DSHEA and the new dietary ingredient notification process – basically the entire regulatory framework of the nutritional supplement industry – while doing nothing to ensure that we have a science-based regulatory process for consumers and the industry alike, and that’s not responsible.
CRN has also inaccurately argued the FDA lacks the authority to set a safe level of consumption for CBD, claiming the agency:
“doesn’t get to decide in advance of a product coming to market what is safe level of use. That’s one of the fundamental tenets of DSHEA.”
Factually, this is completely wrong. This ignores the NDI process, a fundamental statutory tenet of DSHEA that specifies that data has to be provided to FDA on safety of a new dietary ingredient 75 days prior to going to market. For those unfamiliar with the law, it can be viewed here.
More interesting is that CRN recently submitted a citizen’s petition asking the FDA to set a safe level of daily consumption. CRN’s citizen petition states that:
“its own assessment of the publicly available scientific literature and, based on a conservative view of the literature available, proposed a safe amount of up to 40 mg CBD per day.”
It’s not responsible and likely hypocritical for an organization to state it’s not about a safe level to then submit what they believe a safe level is to the regulator? Also, if they were so against efforts to distinguish a daily amount for foods and dietary supplements, why did they provide FDA their own? Additionally, what if a company has specific safety data supporting a level of 100 mg a day, how does this level they established take that into consideration, as there is no apparent data call incorporated into that citizen’s petition.
We, as an industry have to be responsible, scientifically and factually regarding CBD. The fact of the matter is until a CBD bill addresses safety, it will never be taken seriously. FDA said as much when they provided technical assistance on the bill when it was introduced, and subsequently wasn’t advanced in the last congress.
NPA will stick to our core values and principles as it pertains to CBD, being factually accurate and scientifically sound. NPA continues to lead the way on CBD from having the first amendment to pass the House on setting a safe level for CBD to playing a role in the more than 24 state bills on establishing a safe threshold for CBD. It’s bigger than CBD, in the past year NPA was responsible for making sure the industry was deemed essential and stayed open, through our work the industry was listed in the CISA guidelines as essential, we secured legislation from Senator Cramer to expand access to supplements through Health Savings Accounts, ensured supplements are accurately labeled through our work with the Coalition for Accurate Product Labeling, defeated misguided state proposals and supported state proposals exempting supplements from sales and use tax.
The State of California vs Natural Products (Again)
February 23, 2021
Daniel S. Fabricant, Ph.D.
California just became the latest state to introduce legislation that would restrict access to dietary supplements. That makes them the third state this year to propose this sort of action either requiring them to be placed under lock and key or put behind the counter, like cigarettes.
Every day it seems as if another significant industry is leaving California, which is probably part of the reason why the state is facing depleted tax revenues and a $54 billion budget deficit, and we won’t even bring up Prop 65. Our industry has a massive presence in the state providing over 50,000 jobs and over half-a-billion in state tax revenue. Californians’ know and trust our products to be apart of their daily health routines.
Yet, despite this and lawmakers in Washington exploring ways to expand access to supplements, whether through expansion of Health Savings Accounts (HSAs) to include supplements, by members of congress recognizing the benefits of vitamin D intake and encouraging the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) to issue guidance on vitamin D intake for elderly and immunocompromised individuals during the ongoing pandemic, the California state legislature is looking to punish responsible retailers and manufacturers. In fact, their proposal is so extreme the penalties are more severe than selling cigarettes or alcohol to a child.
Let me say that again, the proposed fines would be $1,000 dollars for failing to restrict access to a supplement, compared with a $200 and $250 dollar fines respectively for selling alcohol or cigarettes to minors. Selling dietary supplements shouldn’t be a crime.
We know some people don’t want their business to be involved with politics, however, politics (like it, or not) is ALWAYS involved in your business. This is why if you’re not a member of NPA, there has never been a more critical time to join the industry’s oldest and largest trade association. Joining NPA provides you with the opportunity and resources necessary to defeat out-of-touch proposals and be a part of the preventative health care solution. For instance, our members have worked tirelessly with our team to provide broader access to supplements through social programs like SNAP and WIC and tax-savings accounts like a Health Savings Account over the last year.
When you join a trade organization, you expect them to provide you with services that elevate your voice within the industry and elevate the industry’s voice with regulators, lawmakers across all levels of government, and the media. Keeping businesses open and thriving, that’s the best return on investment.
Speaking for Natural starts with us. In 2020, NPA members sent over 20,000 personal messages to federal, state, and local officials in support of the natural products industry. Their support of the industry helped defeat dangerous proposals that like this one. The result has been congressional action and recognition by leaders in Congress that natural products play a significant role in our everyday lives to stay healthy. It’s time to join a team that has and will continue to be the voice of the industry, it’s time you explored membership opportunities with NPA. Thank you to those of you who are members, together we will continue advocating for a more accessible marketplace.
Please go to this link for more information about membership benefits and joining NPA.
Strengthening State CBD Laws Amid FDA Purgatory
February 4, 2021
Daniel S. Fabricant, Ph.D.
CBD is everywhere; even industry giants like Molson Coors are looking to cash in on the craze. Yet, the regulatory environment has remained murky. To date, CBD remains illegal as a dietary ingredient. Despite the illegality, the Food and Drug Administration’s enforcement has been tied to companies selling products claiming to treat medical conditions.
The lack of enforcement from the FDA has left industry in a purgatory. Left waiting are the companies who have established integrity by providing their consumers with safe and reliable products. All while consumers canvas the CBD market trying to determine which products are legitimate.
The dietary supplement industry has worked hard to ensure consumers are getting the safest and most reliable products in the world. We have worked with state and federal regulators to bring the CBD market up to speed and establish an appropriate regulatory pathway for CBD as a dietary ingredient.
Inaction by the nation’s leading public health agency has left industry hamstrung. However, a glimmer of solace can be seen at the state level. At least 21 states currently allow the sale of hemp and CBD as a food or dietary supplement, including in New Hampshire, where we provided the committee with written testimony. While many states such as Florida, Ohio, Texas, and California have introduced or passed legislation, other states like Maryland have aligned with FDA’s position that CBD is not legal in food or dietary supplements.
In the wake of states establishing their regulations and standards guiding the industry, Congress should mandate that the FDA establish the Hemp Food & Supplement State Safety Cooperative Program (HFSSSCP). Modeled after the FDA’s State Milk Safety Cooperative Program, the HFSSSCP would establish a dosage recommendation based upon readily available data and develop an official analysis method for hemp-derived CBD products. This program would strengthen current state laws by protecting consumers from potentially unsafe or poor-quality CBD foods and supplements. Additionally, implementing these regulations would serve as the uniform standard for testing foods and dietary supplements that purport to contain CBD.
A program such as this would delineate both the FDA’s and the state’s responsibilities, all while standardizing controls over CBD in foods and supplements. As states continue to develop their standards, the FDA must assist state regulatory agencies in preventing adulterated products from coming to market. Programs such as this would provide the industry with the guidance we so desperately desire.
Modernizing How We View Our Health
February 2, 2021
Daniel S. Fabricant, Ph.D.
Over the last year, we have become increasingly aware of the importance nutrients play on our immune systems. A recent study in the American Journal of Clinical Pathology revealed people who have low levels of vitamin D are at higher risk of contracting COVID-19 and suffering more severe illness. The researchers also found vitamin deficiency upon admission to the hospital resulted in 3.7-fold higher mortality rate of individuals with the disease, regardless of other risk factors.
The findings from this study aren’t a new revelation, in fact, several studies have been published citing a connection between vitamin deficiency and COVID-19 mortality. At a time when consumers are acutely aware of the importance of nutrition, consumers should be able to utilize savings accounts, like Flexible Spending Accounts, Health Savings Accounts, and Health Reimbursement Accounts, to pay for expenses related to their health and wellness.
These savings accounts are set up by an employer for an employee and allow enrollees to contribute a portion of their regular earnings to pay for qualified expenses related to medical costs. These pre-tax dollars can be used for things such as bandages, feminine hygiene products and crutches. However, vitamin supplements such as vitamin-D, vitamin-C or zinc are not eligible for purchase without a prescription.
North Dakota Senator Kevin Cramer’s bill S.4463 from last Congress would modernize the treatment of vitamins like vitamin-D so consumers would be able to use their HSA/FSA/HRA. If legislators are serious about promoting healthy choices and lifestyles, then supporting this legislation for re-introduction in the 117th Congress is a must.
Legislation like this, provides consumers with greater choice, promotes healthy lifestyles, and encourages consumers to take preventative measures when it comes to their health. It comes at no cost for government all while modernizing how we view our health, especially the concept of self-care.
Per the WHO – “Self-Care is what people do for themselves to establish and maintain health, and to prevent and deal with illness. It is a broad concept encompassing hygiene (general and personal), nutrition (type and quality of food eaten), lifestyle (sporting activities, leisure, etc.), environmental factors (living conditions, social habits, etc.) socio-economic factors (income level, cultural beliefs, etc.) and self-medication”
Committing to self-care (Nutrition) will preserve your ability to rise to the challenge of this time. As we return to a new normal, we cannot overlook the damage done to America’s physical and mental health during this pandemic, therefore we are all are forced to care more for ourselves, and that will only come to fruition by having greater freedom in the marketplace by removing the barriers to make choices for self-care.
Senator Cramer’s legislation is a great first step. However, there must be more leaders in Washington who will take the initiative to not just support this legislation but bring it up for a vote. Be sure to write your senators and representatives in the US house demanding they take the necessary steps here.
New Year, Same You
January 6, 2021
Daniel S. Fabricant, Ph.D.
A Happy New Year to all of the fine folks out there that occasionally hang in this corner of the internet. You might have noticed that it has been a little quiet over here. We’ve been fighting for the industry to ensure that businesses like yours can stay open and serve millions of Americans that are turning to products you sell to support their health during the pandemic. The federal government acknowledged that we are essential, and we have fought in every single state in the country to keep your doors open.
We’re starting the year off right and planning to get this blog up and running again. Because New Year, new me, new content, right? But unfortunately, we’re seeing more of the same old bad ideas out of the state legislature in New York.
Just this week, a bill was introduced in the NY state legislature that would ban the sale of nutritional supplements like protein powder to minors, placing unnecessary burdens on small businesses, and driving people to online retailers while brick-and-mortar stores like yours are fighting to stay open.
We’ve fought similar proposals like this before, we’re already fighting this one, which is why you belong to NPA (and if you read the blog – become a member, no one likes freeloaders) but why does this seem to become an annual (or depending on the state legislative session, biannual) rite of passage for the industry?
Why do legislators think it’s a good idea to attack our industry, especially now with all the goodwill surrounding our efforts and the science on ingredients like vitamin D, Zinc, and so many other Americans are using to stay healthy? We’re unsure why, but what we do know is that we need you as an industry, and as a member of NPA to take action and let lawmakers know that proposals like these are unacceptable.
When we see proposals that burden small businesses, or create programs serving only narrow interests, including the narrow interests of politicians, we have an obligation to speak up. If you have never contacted any of your elected officials (Federal, State or Local) about your role in the industry and the good you or your company does, we’ll make it easy for you. Click here to take action today.
Unless of course you’ve already given up hope on your resolutions for 2021.
