Tag Archives: dietary supplements

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FDA CFSAN Announces Priority Guidances for Remainder of 2023

By Food Safety Tech Staff
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Infant food safety, including new arsenic and cadmium action levels, are among the new priorities the FDA plans to address before the end of 2023. On July 6, the FDA Center for Food Safety and Applied Nutrition (CFSAN) and Office of Food Policy and Response (OFPR) released an updated list of draft and final guidance topics that are a priority for the FDA Foods Program to complete during 2023.

The following guidance topics have been added to the 2023 agenda:

  • Draft Guidance on Dietary Supplement Master Files
  • Draft Guidance on Low-Moisture Ready to Eat Foods (including infant formula)
  • Draft Guidance on Action Levels for Arsenic in Food Intended for Babies and Young Children
  • Draft Guidance on Action Levels for Cadmium in Food Intended for Babies and Young Children
  • Amendment to the Menu Labeling Supplemental Guidance
  • Guidance on Protein Efficiency Ratio (PER) Rat Bioassay Studies to Demonstrate that a New Infant Formula Supports the Quality Factor of Sufficient Biological Quality of Protein.

Public comments on the list of human food and cosmetic guidance topics, including suggestions for alternatives or recommendations on the topics the FDA is considering, can be submitted to www.regulations.gov, using Docket ID: FDA – 2021-N-0553.

The FDA’s list of guidance topics is just one of several resources that the Foods Program routinely shares with stakeholders and partners to inform them of agency priorities. Most proposed and final rules are on the “Unified Agenda of Regulatory and Deregulatory Actions,” which is published by the Office of Information and Regulatory Affairs in the Office of Management and Budget. The Unified Agenda is updated twice a year and reports planned actions by federal departments and agencies government wide. A list of those FDA regulations and guidance documents under Administration review is available on the Office of Management and Budget website.

 

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FDA Issues Two New Guidances on Food Allergen Labeling Requirements

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The FDA has issued two new guidance documents on food allergen labeling requirements.

Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5); Guidance for Industry updates the previous edition (Edition 4) with new and revised questions and answers related to the labeling of food allergens, including requirements in the Food Allergy Safety, Treatment, Education, and Research Act of 2021 (FASTER Act) and the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA).

The FALCPA amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by defining the term “major food allergen” and requiring that foods or ingredients that contain a major food allergen be specifically labeled with the name of the allergen source. This law identified eight foods as major food allergens: milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, and soybeans. The FASTER Act adds sesame to the list of major food allergens effective January 1, 2023.

The draft guidance includes:

  • New questions and answers about food allergen labeling requirements, such as the labeling of sesame, milk, and eggs; the labeling of major food allergens in the labeling of dietary supplement products; and other technical labeling issues.
  • Revised questions and answers to update and clarify information presented in earlier editions of the final guidance, such as the labeling of tree nuts, fish, and crustacean shellfish.
  • Images that show examples of labeling requirements.

The agency also issued a final guidance with the same title to preserve the questions and answers from the previous edition (Edition 4) that were not changed, except for editorial changes such as renumbering the questions and reorganizing the information in the guidance.

Stakeholders can submit comments about the draft guidance within 60 days of the November 30 publication of the notice in the Federal Register. Submit comments electronically on www.regulations.gov or by mail:

Dockets Management Staff
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document’s Docket ID: FDA-2022-D-0099.

Susanne Kuehne, Decernis
Food Fraud Quick Bites

The Very Mellow Yellow

By Susanne Kuehne
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Susanne Kuehne, Decernis
Adulteration
Find records of fraud such as those discussed in this column and more in the Food Fraud Database. Image credit Susanne Kuehne.

Lead chromate, flour, curcuma, Metanil Yellow or Sudan Dye, anyone? These are just some of the possibly hazardous adulterants that may make their appearance in turmeric, a popular and pricey spice and ingredient in dietary supplements. The American Botanical Council published a laboratory guidance document to determine the proper methods for the analysis of a number of adulterants. The document gives lists of the methods with their pros and cons, grouped by type of adulterant.

Resource

  1. Cardellina II, J.H., Ph.D. (2020). “Turmeric Raw Material and Products Laboratory Guidance Document”. American Botanical Council.
Karen Everstine, Decernis
Food Fraud Quick Bites

Adulteration of Botanical Ingredients

By Karen Everstine, Ph.D.
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Karen Everstine, Decernis

Botanical ingredients are important to the food and beverage industries as well as the dietary supplements industry. Botanicals are plants or specific plant parts (leaves, roots, bark, berries, etc.) that are used for particular properties. These properties can be therapeutic or related to color, flavor or other attributes. Botanicals include extracts such as Ginkgo biloba, saw palmetto, and elderberry as well as herbs and spices used in cooking, essential oils, pomegranate juice and extracts, and olive oil. There is a substantial overlap between botanical products used in the herb and supplement industries and those used in foods and beverages. Many “conventional” foods and beverages include botanical extracts or other ingredients to advertise a therapeutic effect.

In 2014, FDA issued a final guidance for industry related to labeling of liquid dietary supplements (vs. beverages). FDA noted, in their rationale for the guidance, two trends:

“First, we have seen an increase in the marketing of beverages as dietary supplements, in spite of the fact that the packaging and labeling of many liquid products represent the products as conventional foods. Products that are represented as conventional foods do not meet the statutory definition of a dietary supplement…and must meet the regulatory requirements that apply to conventional foods.

Second, FDA has seen a growth in the marketplace of beverages and other conventional foods that contain novel ingredients, such as added botanical ingredients or their extracts. Some of these ingredients have not previously been used in conventional foods and may be unapproved food additives. In addition, ingredients that have been present in the food supply for many years are now being added to beverages and other conventional foods at levels in excess of their traditional use levels or in new beverages or other conventional foods. This trend raises questions regarding whether these ingredients are unapproved food additives when used at higher levels or under other new conditions of use. Some foods with novel ingredients also bear claims that misbrand the product or otherwise violate the FFDCA.”

The American Botanical Council (ABC) has been publishing information on the safe, responsible and effective use of botanicals since 1988, including the quarterly journal HerbalGram and a book of herb monographs The ABC Clinical Guide to Herbs. In order to help combat the increasing problem of adulteration in the industry, the Botanical Adulterants Prevention Program (BAPP) was launched in 2010 by ABC along with the American Herbal Pharmacopeia and the University of Mississippi National Center for Natural Products Research. The goal of BAPP is to educate members of the herbal and dietary supplement industry about ingredient and product adulteration through the publication of documents such as adulteration bulletins and laboratory guidance documents. The information in these documents helps ensure the identity, authenticity and safety of botanicals along the supply chain.

Karen Everstine will be discussing food fraud during the 2020 Food Safety Consortium Virtual Conference Series | An example of the Botanical Adulterants Prevention Bulletin for cranberry is seen in Figure 1. It includes a description of the species that can be labeled as cranberry in the United States, a brief description of the marketplace, information on potential adulterants in cranberry fruit extract and other cranberry products, and guidance on analytical methods to test cranberry products for adulteration.

Cranberry adulteration, Botanical Adulterants Bulletin
Figure 1 courtesy of Decernis and the Botanical Adulterants Bulletin.

Decernis has been working with the Botanical Adulterants Prevention Program (BAPP) to integrate links to their expert content into the Food Fraud Database (FFD). This will ensure our users can better develop ingredient specifications, manage risk, and protect their consumers by leveraging this content for food fraud and herbal ingredient fraud prevention. We are currently incorporating three types of BAPP documents into FFD:

  • Adulterants Bulletins. Information and links to these documents will be entered as Inference records in FFD. We are extracting ingredient and adulterant names (including Latin names as synonyms) from the document, assigning “Reasons for Adulteration,” and providing a link to the full document on the BAPP website.
  • Adulteration Reports. Information and links to these documents will also be entered as Inference records in FFD. We are extracting ingredient and adulterant names from the document, assigning “Reasons for Adulteration,” and providing a link to the full document on the BAPP website.
  • Laboratory Guidance documents. Information and links to these documents will be entered as both method record and inference records in FFD. We are extracting ingredient and adulterant names from the document, assigning “Reasons for Adulteration,” and providing a link to the full document on the BAPP website.

Decernis analysts are currently integrating this content into FFD, which will be uploaded to the system between now and early September.

Cori Goldberg, Reed Smith
FST Soapbox

USDA Publishes Hemp Rules: Will It Impact Food?

By Cori Goldberg, Adam Brownrout, John Kendzior
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Cori Goldberg, Reed Smith

On October 29, 2019, the USDA released its long-awaited draft rule establishing a domestic hemp production plan, providing clarity to growers and ancillary businesses about how the USDA will regulate the hemp crop. The USDA, under authority provided by the 2018 Agricultural Improvement Act (2018 Farm Bill), was tasked with promulgating regulations and guidelines to establish and administer a program for the production of hemp in the United States. This rule has now arrived and been published in the Federal Register. The rule provides requirements for all state and tribal hemp production plans including requirements for testing hemp, licensing growers, disposing of non-compliant hemp, and collecting and storing information related to hemp production. The USDA will now accept public comment on the rule until December 30, 2019.

Although the USDA rule will greatly contribute to the expansion of legally grown hemp in the United States, this rule does not alter the law regarding CBD foods and CBD dietary supplement products. This is because the 2018 Farm Bill left intact FDA’s authority to regulate the sale and marketing of CBD foods, dietary supplements, drugs, and cosmetics, as those product types fall under FDA’s purview generally. FDA has allowed the sale of CBD cosmetics, with certain restrictions, and companies may submit CBD products to FDA through FDA’s drug approval process. However, it has maintained that the addition of CBD to foods and dietary supplements is illegal. Under the federal Food, Drug, and Cosmetic Act (FDCA), once a substance is approved as an Active Pharmaceutical Ingredient (API) in an FDA-approved drug, that substance may not be placed into interstate commerce in a food. Also under the FDCA, once a substance is approved as an API in an FDA-approved drug, that substance is excluded from the definition of a dietary supplement. FDA approved the pediatric epilepsy drug, Epidiolex, whose API is CBD. Therefore, FDA has concluded that CBD may not be placed into foods in interstate commerce and that CBD products are excluded from the dietary supplement definition and therefore may not be sold as dietary supplements. The USDA rule does nothing to change the legal status of CBD food or dietary supplement products. Thus, despite the expected increase of hemp availability following the passage of the USDA rule, CBD companies must wait for the FDA green-light in order to manufacture or sell hemp-derived CBD food products lawfully.Learn more about important regulatory & quality issues in the cannabis space from Cannabis Industry Journal

However, the rule does state that additional hemp is necessary to support the growing CBD market, and it notably put pressure on FDA by stating that if “FDA does not provide clarity about their plans for future regulation of CBD, there will continue to be uncertainty and downward pressure on the CBD portion of the hemp market.”

So what does the USDA rule do? Under the USDA rule, states and tribes will have the option of either submitting a proposed hemp regulation plan to the USDA for approval or agreeing to submit to the USDA’s general requirements. All state and tribal plans must include certain provisions, including but not limited to:

  1. Land used for production: State and tribal plans must identify a process for collecting, storing and maintaining relevant information regarding land used for growing hemp in the state. This includes information regarding the description, acreage, and boundaries of the farm land.
  2. Sampling and testing for delta-9 tetrahydrocannabinol (THC): State and tribal plans must implement testing procedures to ensure that plants do not exceed THC levels above 0.3% (as provided in the 2018 Farm Bill). All testing facilities must be DEA approved, as non-compliant product with THC levels over 0.3% would be considered “marihuana” and a schedule 1 substance under the Controlled Substances Act of 1970 (CSA). Additionally, laboratories will be required to report a “measure of uncertainty” in their testing, designed to provide a buffer for the potential variation in sampling and testing procedures. Accordingly, plants testing higher than 0.3% THC but still within the “measure of uncertainty” will be considered compliant.
  3. Disposal of non-compliant products: States and tribes must develop a procedure for destroying non-compliant cannabis containing more than 0.3% THC. Because non-compliant product is considered a controlled substance, all product must be disposed of in a manner consistent with the CSA. Therefore, product must be collected and destroyed by a DEA agent or law enforcement officer.
  4. Inspection of hemp producers: States and tribes must develop procedures for inspecting hemp producers on an annual basis and also for inspecting random samples. The state must also develop procedures to identify and attempt to correct certain negligent acts such as not obtaining licenses or producers exceeding acceptable hemp THC levels.
  5. Information sharing: State and tribal plans must include procedures for reporting information to the USDA. This information must be provided to the USDA within 30 days of receipt from the hemp producers and includes contact information for all hemp producers in the state, legal descriptions of the land used for hemp production, and the license status of all hemp producers in the state.
  6. In states and tribes without an approved or proposed plan, hemp producers will be subject to the USDA general plan. The general plan also provides similar requirements for the testing and sampling of hemp. The USDA will provide licenses directly to hemp producers in states without an approved or submitted plan as some states may not want to have primary regulatory authority of hemp. These states will essentially hand over regulatory responsibility to the USDA. These licenses will be available by application 30 days after the final rule is published. Notably, the draft USDA rule also provides that states and tribes are restricted from prohibiting the transportation or shipment of hemp or hemp products produced under a state plan, tribal plan or a license issued under the FDA. The interstate commerce provision should put an end to the arrests of those transporting legally produced hemp from one state to another. For example, in July 2019, a trucker was arrested and charged with felony possessions of marijuana and intent to distribute while transporting legally grown hemp through South Dakota (South Dakota still considers hemp a controlled substance).

So while the USDA rule is much anticipated and grabbed the attention of many when published, food and dietary supplement manufacturers, distributors, and retailers are still stuck where they were before. We will all continue to wait and see what FDA will do.

Resource

  1. “Establishment of a Domestic Hemp Production Program”. (October 31, 2019). Federal Register. Retrieved from https://www.federalregister.gov/documents/2019/10/31/2019-23749/establishment-of-a-domestic-hemp-production-program.
Karen Everstine, Decernis
Food Fraud Quick Bites

A Different Type of Food Fraud

By Karen Everstine, Ph.D.
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Karen Everstine, Decernis

Food Fraud: Problem Solved? Learn more at the 2019 Food Safety Supply Chain Conference | May 29–30, 2019 | Attend in Rockville, MD or virtually The typical motivation for food fraud is replacing a more expensive ingredient with a less expensive one, thereby increasing profits or competitiveness on the market. Another form of fraud involves the use of active pharmaceutical ingredients in products marketed as dietary supplements or foods containing dietary supplements.

Last month, an instant coffee drink purportedly containing “natural herbs” tongkat ali, guarana, and maca was reported to actually contain two pharmaceutical ingredients (APIs) approved by the FDA for the treatment of male erectile dysfunction. In this case, the motivation for fraud is “spiking” with the “intent to impart an effect that cannot be achieved by the dietary ingredients alone.” This is an ongoing challenge for regulators and other stakeholders who work to ensure the safety of the supplements market. This type of fraud in dietary supplements is also an important health risk to consumers, since unintentional consumption of APIs can result in unintended side effects or adverse interactions with other drugs. A quick glance at the FDA’s Medication Health Fraud Page illustrates how common this type of adulteration is, most notably in products advertised for erectile dysfunction, weight loss and sports performance.

In March, an energy drink was banned in Zambia after Ugandan authorities determined it contained sildenafil citrate (the active ingredient in Viagra). In 2015, Chinese authorities investigated distillers of a popular liquor under suspicion of adding the same substance. Adding to the challenge of this type of fraud is the fact that certain consumers may view food and dietary supplement products containing APIs as more appealing, not less.

Both manufacturers and consumers should use good judgment when purchasing dietary supplements or foods marketed as containing dietary supplements. There are educational resources available for consumers and guidance for industry to support the quality assurance and safety of these products. These include the NIH Office of Dietary Supplements and the National Center for Complementary and Integrative Health, the American Botanical Council, the American Herbal Products Association and USP.

Images of the recalled product from FDA’s website. Records involving fraud can be found in the Food Fraud Database.

Dietary Supplements: Verifying Label Claims “By Input” Unacceptable

By Tara Lin Couch, Ph.D.
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FDA issued more than 400 Warning Letter citations for inappropriate specifications in dietary supplement during 2013 and 2014. Many of these violations were due to a failure to have Finished Product Specifications, but recent citations have also noted that using solely the input of a dietary ingredient for verifying the strength “By Input” is unacceptable.

The FDA regulations dictated in 21 CFR 111, Current Good Manufacturing Practice (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, require that each batch of a finished dietary supplement product must meet quality requirements for identity, purity, strength, composition, and limits of potential contaminants.

Criteria used to establish that these requirements are met are supposed to be provided in a Finished Product Specification developed by the dietary supplement company. FDA issued more than 400 Warning Letter citations for inappropriate specifications in 2013 and 2014. Many of these violations were due to a failure to have Finished Product Specifications at all, but recent Warning Letters have also noted that using solely the input of a dietary ingredient for verifying the strength “By Input” is unacceptable.

The input of a dietary supplement alone is not a scientifically valid analytical test method for determining the strength of a dietary ingredient in a finished product. Chemical testing of the ingredient should be accomplished whenever possible. If that is not possible due to the unavailability of a scientifically valid test method, the testing may be exempted provided dietary ingredient raw material testing, in-process testing, other finished product testing, process controls, and additional information can support that the strength of the dietary ingredient can be verified without testing, as allowed in 21 CFR 111.75(d)(1).

The incoming dietary ingredient raw material must be verified to meet quality requirements for identity, purity, strength, and the lack of potential contaminants. Warehouse controls must then ensure that the material is held in a condition in which its quality is not altered. The material must be formulated at an appropriate amount, with sufficient overage, to meet the label claim while taking into account manufacturing variability. This is dictated in an approved Master Manufacturing Record (MMR). Once executed, the Batch Production Record (BPR) must document that the correct amount of the dietary ingredient was actually dispensed into the product during manufacture. Established in-process examinations and tests are then used to verify that the batch is uniformly mixed and meets the unit dosage weight and weight variation requirements. Variations on weight cannot exceed the overage amount to ensure that even the smallest dosage unit still complies with the label. In-process chemical tests can also be employed to verify the amount of a dietary ingredient. This can be particularly beneficial if the reason a dietary ingredient is exempted from testing is because of matrix interferences or instrumental quantitation limits.

Other finished product testing can also be used to support that an exempted ingredient is present in the product at the correct, labeled amount. Test results from chemically similar ingredients that are determined to be as expected suggest that the exempted ingredient is also present at expected levels because these ingredients will tend to react the same way during manufacture, especially if both ingredients are introduced and processed in the same step. Results obtained from finished product testing of other ingredients whose concentrations are associated with the exempted ingredient may also support that the exempted ingredient is present as expected.

Finally, the number of other finished product ingredient tests that are performed is important. If all other test results are determined to be within specification, it indicates that the product was manufactured according to the MMR and there is no reason to expect anything different from an exempted dietary ingredient.

Dietary supplement companies that are compliant with all parts of 21 CFR 111 will already be performing these activities. A procedure that summarizes the overall process of verifying the addition of a dietary ingredient can then be created and used as the test method reference on the Finished Product Specification. A separate document that describes the details of test exemptions per product should also be generated. The actual result obtained should be acquired from the completed batch production record.

The “By Input” approach is no longer relevant.

This article originally appeared in EAS-e-News February 2015 issue.