Archive February 2023
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AHPA submits comments to FDA on proposed rule for “healthy” claims
February 23, 2023
Last week, the American Herbal Products Association (AHPA) submitted comments to the U.S. Food and Drug Administration (FDA) requesting revisions to the proposed rule updating the regulation governing “healthy” claims for food products, including dietary supplements. This proposed rule follows a 2016 Federal Register notice in which FDA invited comments on the term “healthy” as a nutrient content claim in the context of food labeling, to which AHPA also submitted comments.
The current regulation governs the use of the term “healthy” (and related terms, such as “healthful” or “healthier”) as an implied nutrient content claim on the label or in labeling of a food is codified at 21 C.F.R. § 101.65(d)(2). This regulation establishes specific criteria for these claims related to the levels of fat, saturated fat, cholesterol, and other nutrients present in different food categories permitted to make such claims.
“Dietary supplements are intended to support a healthy diet and lifestyle and, per the current dietary guidelines, a healthy diet can include herbs and herbal products,” said Robert Marriott, AHPA Director of Regulatory Affairs. “AHPA’s position is that dietary supplements, unsweetened coffees and teas, and herbs and spices should be able to bear ‘healthy’ claims. We have expressed this position to FDA in our comments, among other requests that support uses of the term ‘healthy’ that will help consumers make beneficial diet choices.”
Dietary supplements should be able to bear “healthy” claims
Among the elements of its extensive comments, AHPA asserted that the proposed rule should not restrict the use of “healthy” claims on dietary supplements. Noting references to the necessity of dietary supplements in helping consumers meet the current U.S. Dietary Guidelines, AHPA argued that completely prohibiting the use of “healthy” claims on dietary supplements would be inconsistent with the goals of the proposed rule to promote healthy dietary practices and that a prohibition would create potential confusion regarding other lawful dietary supplements claims that use the word “healthy.”
In the event that FDA declined to exempt dietary supplements from the “healthy” claim requirements, AHPA also suggested two alternative proposals to address such claims for dietary supplements: (i) exempting them from the newly proposed food group equivalent requirements; or (ii) revising the proposed rule to specifically allow “healthy” claims on dietary supplements that contain vitamins and minerals referred to in regulation as “essential in human nutrition,” including nutrients of public health concern.
Unsweetened coffees and teas, herbs, and spices should also be permitted to bear “healthy” claims
AHPA also encouraged FDA to permit the use of “healthy” claims for unsweetened coffees and teas in line with nutritional evidence supporting their use as a healthy substitute for caloric or sugar-sweetened beverages.
Similarly, AHPA also encouraged FDA to permit the use of “healthy” claims for products consisting of single or mixed herbs and spices that do not include sodium, added sugars, or saturated fats, such as those used in flavoring home-cooked meals and dishes.
Requests for clarification and other enforcement revisions
Among its other comments, AHPA requested that FDA revise the proposed rule and associated communications to clarify that the final rule does not restrict use of the term “healthy” in the context of other lawful product claims (e.g., inclusion of the word “healthy” as part of lawful structure function claims). AHPA also recommended that FDA refrain from reducing sodium limits applicable to “healthy” claims due to a lack of new evidence supporting such a reduction. AHPA also requested further enforcement discretion for products already in commerce at the time of the revised rule’s compliance date.
Continued engagement and advocacy
AHPA has closely followed FDA’s proposed updates to the regulation of “healthy” label claims for several years and will continue to engage with the agency on this matter as it relates to dietary supplements and herbal products.
“AHPA and our members know dietary supplements and herbal products inside and out; these products can help consumers maintain healthy dietary patterns,” added Michael McGuffin, AHPA President. “As such, we will continue to advocate for these products to be able to bear ‘healthy’ claims.”
Herbs in History: Pomegranate & Turmeric
In an effort to preserve and share the fascinating histories of medicinal plants and herbs that have been used around the world for ages, the AHPA Foundation for Education and Research on Botanicals (AHPA-ERB Foundation) is honored to partner with Alain Touwaide, Ph.D., and Emanuela Appetiti of the Institute for the Preservation of Medical Traditions to tell the stories of Herbs in History.
The first entries of the year continue with pomegranate and turmeric. Preview the entries below and visit Herbs in History online to read more.
Pomegranate (Punica granatum L.)
A Plant with a Pedigree
If there is a plant that may claim to have accompanied Humankind from its origins to present day, it is without doubt pomegranate.
In the biblical narrative of Adam and Eva (Genesis, chapter 3), the serpent in the Garden of Eden led Eva into temptation pushing her to eat the fruit of the Tree of Knowledge, whereas God had commented them to neither eat nor touch it. Desiring wisdom, Eva ate the prohibited fruit, and gave it to Adam. Both were expelled from the Garden by God, and, from then on, Humankind eats bread “by the sweat of their face.” The ancient text refers to a fruit that has been identified as a fig by the early Christians and, further on, as an apple. But couldn’t it be a pomegranate according to the Iranian interpretation? | Read more...
Turmeric (Curcuma longa L.)
Turmeric from Curcuma longa L. (fam. Zingiberaceae) is an almost mythic plant that attracts because of both the fascination of the East and, possibly more, its radiant color, of a deep, bright, and sunny yellow.
To the Root
Now mostly known in the form of a fine powder or short fragments of roots, Turmeric is the rhizome of Curcuma. Whereas Carl Linnaeus identified two species (Curcuma rotunda and C. longa), these appeared to be two types of the rhizome of the C. lunga species: the central rhizome corresponding to Linnaeus’ C. rotunda and the elongated, lateral one to C. longa. Current taxonomy identifies possibly 80 species in the genus, half of which are indigenous to India. | Read more...
About the Project
Herbs in History is made possible by funding from the AHPA-ERB Foundation, as part of the nonprofit foundation’s mission promote education and research on medicinal, therapeutic, and health-promoting herbs. Tune in monthly for thoughtfully detailed historical accounts of herbs you know and love, and learn more about the origins of medicinal plants that have stood the test of time.
Manufacturing Herbal Supplements for a Demanding Market
Strong relationships between contract manufacturers and their suppliers and clients support innovation and help meet growing consumer demand.
February 10, 2023
By Michael McGuffin, President, AHPA | Nutraceuticals World
In the three years since COVID-19 first upended seemingly all areas of life, all over the world, makers of herbal products and dietary supplements have adapted to the changed industry landscape.
Able to operate through pandemic restrictions as essential businesses, contract manufacturers weathered disruptions to the global supply chain—such as ingredient shortages and significant packaging price increases—to meet the increase in demand for botanicals to support health and wellness. What began as a spike in demand has become consecutive year-over-year growth in retail sales of herbal dietary supplements by upwards of more than $1 billion annually.
Contract manufacturers, including many American Herbal Products Association (AHPA) members, largely consider strong relationships with both suppliers and clients as key for meeting the growing demand for the product category and innovating as market trends change.
All Eyes On the Supply Chain
Over the course of the pandemic, everyday consumers and businesses have grown increasingly aware of the global supply chain as they experienced the impacts of disruptions to the supply, production, and transportation of retail goods. While household items like toilet paper and hand sanitizer often sold out, herbal dietary supplements also flew off the shelves.
In particular, more people wanted products containing herbs associated with boosting immune health and helping the body manage stress—such as elderberry and ashwagandha, respectively. Global supplies of these herbs quickly diminished and were slow to be replenished, reflecting in large part the limitations of where, when, and the speed at which these generous plants grow.
This herbal supply shortage left many companies unable to fulfill orders due to out-of-stock ingredients and the cost-prohibitive nature of reformulating. Contract manufacturers that had strong relationships with their suppliers, however, fared better in sourcing high-quality botanical raw materials needed to keep production going and products in stock.
“Because we have such great, long-term relationships with our vendors, while everyone was trying to buy echinacea, goldenseal, etc., our suppliers called us and said, ‘Here’s what we have,’” recalled Mitch Coven, CEO of Vitality Works.
Based in Albuquerque, NM, Vitality Works has manufactured herbal, vitamin, and other dietary supplements for over 40 years, partnering with growers and suppliers from across the globe to source freshly harvested botanicals. Coven credited the strength of the company’s relationships with suppliers, coupled with maintaining a healthy cash flow and minimizing financial leverage, for Vitality Works’ growth that has continued through the challenges of the pandemic.
Now that herb supplies have stabilized and many marketers can maintain plenty of inventory to meet existing demand, contract manufacturers are working closely with their clients to innovate as herbal dietary supplements remain popular across mainstream and natural retail channels.
Trends to Watch
After adding herbs to their health regimens, consumers are now increasingly looking for more product variety and more benefits from dietary supplements. Fortunately, herbs contain an assortment of nutrients, traditional formulas combine several botanicals, and dietary supplements come in many forms to meet diverse consumer preferences.
“We are seeing a lot more brands wanting to stack functions and make diversified blends that stand out on the shelf,” said Sarah Vito, director of business development for Yellow Emperor. “People are also more open to different delivery formats and the taste of natural flavors.”
Yellow Emperor strives to meet ever-evolving consumer interests and the resulting demand for innovative dietary supplement products. Based in Eugene, OR, the West Coast contract manufacturer has exclusively produced liquid dietary supplements, foods, and personal care products for more than 40 years.
Though gummies have skyrocketed in popularity and now represent the largest non-pill share of the dietary supplement market by consumer sales, liquids have seen a resurgence as well. “We’re working with brands that are looking for unique liquids to complement their other dietary supplement offerings,” Vito added. “We’re also seeing a shift toward alcohol-free formulas that taste good, too.”
Products in development but shelved at the start of the pandemic also may soon reemerge, which would create new dietary supplement trends to watch. The demand for products to support immune system health has slowed due to market saturation and other factors, making space for dietary supplements to support other areas of health, such as mental acuity and digestion.
“We are seeing the very beginning stages of backlogged products and ideas coming back,” explained Mike Finamore, CEO of Gemini Pharmaceuticals.
Headquartered in Commack, NY, Gemini Pharmaceuticals has been developing and manufacturing dietary supplements and over-the-counter pharmaceuticals for over 40 years. As a contract development and manufacturing organization (CDMO), Gemini Pharmaceuticals works closely with its clients from concept to finished product.
“Successful companies are the ones that have ideation pipelines,” Finamore added. “Brands revisiting products that they had expected to launch in 2020 are starting on second or third base with those ideas now, as consumer health interests shift away from COVID response.”
Just as strong, long-term relationships with suppliers were crucial to navigating ingredient shortages, contract manufacturers who have developed trusted partnerships with their clients are in the best position to help companies plan, adjust, and innovate for the future.
“We should feel like a part of your team, and communication should be consistent,” said Vito of the partnership between contract manufacturers and brands. “For instance, you can reach out to us if you’re seeing a trend and want to increase your order, and vice versa; we will keep you informed along every step of the manufacturing process, sharing lead times and projections.”
“By working with brands on product design and development, not only do we help determine things like how much of an herbal ingredient to use, but we also get to help tell the story of herbs as we work with our partners to refine their marketing concepts,” said Finamore of the added benefit of engaging a CDMO from the start of the ideation process.
By outsourcing production and building these close, collaborative relationships with contract manufacturers, dietary supplement companies free up their valuable in-house resources, while staying in control of their products and leveraging the expertise and experience of their manufacturing partners. Though there are many businesses that produce herbal tinctures and capsules, brands are ultimately responsible for the quality of products they sell.
“Complying with federal regulations, like GMPs [good manufacturing practices], is the lowest bar to be in this business; brands should visit their contract manufacturers to perform a full qualification audit,” explained Coven. “I have observed an emerging trend for companies to overreach and dig all the way back to the keys of the kingdom.”
In discussing this further, Coven emphasized the need for strong collaboration to avoid redundancy without compromising quality assurance.
With the market expected to continue to grow as more people embrace herbs for their health and wellness, it is an exciting time to be in the herbal products business. To make the most of emerging opportunities for herbal dietary supplements, established and new marketers alike should look for experienced and knowledgeable contract manufacturing partners—many of which are AHPA members.
AHPA Herbs We Love: Elderberry (with love from Alkemist Labs)
Elderberry (Sambucus nigra)
Packed with antioxidants and vitamins, elderberry has been used to support health and wellness since ancient times and, more recently, has dominated the mainstream retail channel for herbal supplements.
Ensure your products and formulas contain the elderberry (and other high demand ingredients) that your customers are looking for with identity and quality testing by Alkemist Labs, the natural product industry's leading botanical lab.
Learn more about Alkemist Labs and our new Alkemist Assured™ botanical testing program at alkemist.com.
Share the Love
Do you want to celebrate an herb you love for AHPA’s 40th anniversary? Contact Amber Bennett to learn more about sponsoring your favorite herb!
2023 AHPA Board of Trustees Candidates
February 8, 2023
The American Herbal Products Association (AHPA) is pleased to announce the candidates for the 2023 AHPA Board of Trustees election at the upcoming AHPA Annual Member Meeting on Wednesday, March 8, 2023 at Expo West.
2023 AHPA Board of Trustees Candidates
- David Bunting, Herb Pharm
- Bill Chioffi, Nammex
- Edward Fletcher, Native Botanicals, Inc.
- Taryn Forrelli, Traditional Medicinals
- Elise Higley, Oshala Farm
- Catherine Hunziker, WishGarden Herbs
- Diana Morgan, Nutrabolt
- Laura Najera, Metagenics
- Florence Okaro, Standard Process
- Greg Pepping, Kan Herb Company
- Elan Sudberg, Alkemist Labs
- Lynn Warner, Givaudan
- Matt Warnock, RidgeCrest Herbals
- Steven Yeager, Mountain Rose Herbs
Read Candidate Statements here: 2023 AHPA Board of Trustees - Candidate Statements
All AHPA Active members in good standing have the right to vote in this election and will receive voting instructions in separate communications.
Please contact Melissa Do at firstname.lastname@example.org if you have any questions about this election or the voting process.
Trade Associations Commend Senators Lee and Sinema for Highlighting Dietary Supplements and Establishing Natural Products Industry Week
February 8, 2023
Today the American Herbal Products Association (AHPA), the Consumer Healthcare Products Association (CHPA), the Council for Responsible Nutrition (CRN), and the United Natural Products Alliance (UNPA), organizations representing dietary supplement manufacturers, marketers, and ingredient suppliers, released the below statements commending Senators Lee (R-UT) and Sinema (I-AZ) on their Resolution recognizing the importance of dietary supplements and highlighting the natural products industry’s contributions to America’s health and economy.
Data from the latest CRN Consumer Survey on Dietary Supplements released in October 2022 shows 75 percent of U.S. adults report using dietary supplements to help maintain a healthy lifestyle, and a similar survey conducted in July by Consumer Reports put that figure at more than 80 percent. Further, data from CRN’s 2022 Health Care Cost Savings Report indicates that dietary supplement regimens can reduce risks associated with several chronic diseases, as well as contribute to potentially billions of dollars in healthcare cost savings. Specifically, there is evidence that the use of dietary supplement ingredients by targeted populations can significantly reduce direct and indirect medical costs related to health conditions such as coronary artery disease, osteoporosis, and cognitive decline.
AHPA President Michael McGuffin, stated, “We look forward to working with Senators Lee and Sinema, and other Members of Congress, to pursue bipartisan initiatives that raise the visibility of our industry and ensure consumer access to safe, high quality herbal and natural products.”
“Vitamins, minerals, supplements, and other natural products have become a mainstream part of self-care, and consumers are turning to these products more than ever to address nutritional gaps and promote their health and wellness,” said CHPA President & CEO Scott Melville. As more Americans incorporate natural products into their overall self-care plans, CHPA thanks Senators Lee and Sinema for recognizing the ever-increasing role this industry is playing in people’s lives and looks forward to continuing to work with Congress toward comprehensive reforms that ensure continued success and innovation on behalf of U.S consumers.”
CRN President & CEO Steve Mister commented, “We would like to thank Senators Mike Lee and Kyrsten Sinema for highlighting CRN’s Health Care Cost Savings Study data and for supporting our manufacturer and ingredient supplier members in their mission to promote and support healthy lifestyles for consumers.”
Commenting on the resolution, UNPA President Loren Israelsen said, “It is entirely fitting that Congress recognize the anniversary of enactment of the Dietary Supplement Health and Education Act, which has done so much in the past 28 years to help consumers have access to the safe dietary supplements they want. UNPA was proud to have played a role in passing DSHEA and thankful that two supplement advocates, Senators Lee and Sinema, are working to commemorate that achievement for consumers.“
AHPA submits comments to FDA on food allergen labeling guidancecomments submitted to the U.S. Food and Drug Administration (FDA) on January 30, the American Herbal Products Association (AHPA) requested revisions to the draft guidance entitled “Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5): Draft Guidance for Industry.”
AHPA’s requested revisions included:
- Further clarification on the inapplicability of food allergen labeling requirements to non-“nut” plant parts through, in part, adding additional examples of other plant parts, such as flowers, pollen, husks, hulls, sap, and other exudates that are not major food allergens;
- Further clarification on which specific “tree nuts” trigger the allergen labeling requirements since, for example, many food ingredients that do not meet the botanical definition of “nut” are commonly referred to as “nuts” for culinary purposes; and
- Reverting to FDA’s prior approach of publishing and implementing a singular list of “tree nuts” subject to the allergen labeling requirements rather than, as proposed in the draft guidance, leaving the precise scope of “tree nuts” for the regulated industry to determine on an ingredient-by-ingredient basis.
Overall, AHPA’s comments express the need for FDA to clearly clarify and specify the applicability and limits of these food allergen labeling requirements to ensure consumer safety and industry compliance while also protecting against frivolous private lawsuits.
“AHPA is mystified by the approach proposed in this draft guidance by FDA, as the agency appears to be proposing to continue to identify ‘tree nuts’ subject to the federal allergen labeling law that are not, in fact, nuts, that grow on plants that are not, in fact, trees, and that do not present significant (if any) food allergenicity,” commented AHPA President Michael McGuffin. “The agency announced just yesterday that it will be reorganizing its Human Foods Program, which will include reestablishing an advisory committee in order to ‘to obtain independent expert advice’ on issues that FDA addresses. It is obvious that independent expertise is needed if FDA intends to issue accurate guidance on this matter.”