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In the United States, the FDA Center for Food Safety and Applied Nutrition (CFSAN) regulates joint health nutraceuticals as dietary supplements. Joint health nutraceuticals are governed by the legal framework of the Dietary Supplement Health and Education Act (DSHEA) of 1994. Although the FDA does not have a pre-approval process for dietary supplements, it does enforce compliance through post-market enforcement, ingredient notification, and label review. This document summarizes the important FDA regulation relevant to joint health nutraceuticals, including ingredient compliance, New Dietary Ingredient Notification (NDIN) process, reverse engineering tactics, and labeling protocols.

FDA-Compliant Joint Health Nutraceuticals: Ingredient Regulation & Reverse Engineering Strategy 2025

Regulation, Latest   July 14, 2025

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In the United States, the FDA Center for Food Safety and Applied Nutrition (CFSAN) regulates joint health nutraceuticals as dietary supplements. Joint health nutraceuticals are governed by the legal framework of the Dietary Supplement Health and Education Act (DSHEA) of 1994. Although the FDA does not have a pre-approval process for dietary supplements, it does enforce compliance through post-market enforcement, ingredient notification, and label review. This document summarizes the important FDA regulation relevant to joint health nutraceuticals, including ingredient compliance, New Dietary Ingredient Notification (NDIN) process, reverse engineering tactics, and labeling protocols.

Summary of the US FDA Regulation Framework

In the United States, joint health nutraceuticals are dietary supplements, regulated by the FDA, under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Joint health nutraceuticals fall under the jurisdiction of the DSHEA unless a health claim or claims cause the product to be classified as a drug. The FDA will not pre-approve dietary supplements but conducts enforcement of the FDCA during market surveillance. The manufacturer shall provide New Dietary Ingredient Notifications (NDIN) for ingredients that have not been marketed in the U.S. prior to October 1994. [1]  

Approved Ingredients for Joint Health A number of key ingredients used in joint health nutraceuticals have been commonly used and are generally recognized as safe (GRAS) or self-affirmed GRAS.[2] These ingredients include:
Ingredient Source Regulatory Status Functional Role in Joint Health
Glucosamine HCl/Sulfate Shellfish (conventional)/Corn-fermented (vegan) Pre-DSHEA; widely accepted Supports cartilage regeneration and joint cushioning
Chondroitin Sulfate Bovine or shark cartilage Marketed with DSHEA disclaimer Aids cartilage elasticity and hydration
MSM (Methylsulfonylmethane) Synthetic/natural sulfur sources GRAS-notified Reduces inflammation and supports connective tissue
Hyaluronic Acid Rooster combs/microbial fermentation Self-affirmed GRAS or NDIN pending Enhances synovial fluid and joint lubrication
Turmeric (Curcumin) Rhizome extract (Curcuma longa) GRAS when standardized and dose-controlled Antioxidant and anti-inflammatory support
Boswellia serrata Extract Resin of Indian frankincense tree NDIN or self-affirmed GRAS pending Reduces joint stiffness and inflammation
SAMe (S-Adenosylmethionine) Fermentation of yeast or bacteria Self-affirmed GRAS in specific doses Supports cartilage structure and joint mood modulation
Undenatured Collagen (UC-II) Chicken sternum cartilage NDIN filed by several manufacturers Modulates immune response to protect joint cartilage
Algal Calcium Complex Marine algae (e.g., Lithothamnion sp.) GRAS-notified Provides mineral support for cartilage and bone

Real-World FDA-Compliant Joint Health Nutraceuticals

Brand/Product Name Key Ingredients Regulatory Status Structure-Function Claims Claims Validity
Move Free® by Schiff Glucosamine sulfate, chondroitin sulfate, MSM, hyaluronic acid GRAS-notified, pre-DSHEA for glucosamine, self-affirmed GRAS for MSM “Supports healthy joint function”, “Helps maintain joint comfort” FDA-compliant structure-function claims
Tart Cherry Joint Health by Nature’s Way Tart cherry extract, glucosamine, turmeric, Boswellia serrata GRAS-notified for glucosamine and turmeric, NDIN pending for Boswellia “Supports joint health and reduces inflammation” FDA-compliant structure-function claims
Jarrow Formulas® Joint Essentials Glucosamine sulfate, chondroitin sulfate, MSM, hyaluronic acid Self-affirmed GRAS for glucosamine, MSM, and hyaluronic acid “Helps maintain healthy joint structure and function” FDA-compliant structure-function claims

New Dietary Ingredient Notifications (NDIN)

Ingredients that weren’t marketed in the U.S. prior to October 15, 1994, as they relate to joint health nutraceuticals, are the only ingredients that must proceed through the NDIN procedure. Manufacturers must submit the NDIN to the FDA at least 75 days before marketing the similar nutraceutical joint health product. Such ingredients could include items like new peptides, substances that are considered biosynthetic, or glucosamine derived from algae (which would require this notification unless GRAS status was self-affirmed).

FDA-Compliant Joint Health Nutraceuticals thumbnail

Reverse Engineering Occurs in Nutraceutical New Product Development (NPD)

Reverse engineering, in nutraceutical joint health product development is the study of existing joint health supplements that are leading in the marketplace to determine the composition and functional ingredients they comprise. Reverse engineering includes the following:

  • Ingredient profiling, such as estimation ratio of ingredient content through HPLC, FTIR, and NMR for example.
  • Excipient analysis to look for disintegrants, anti-caking agents, etc.
  • Reformulation or adjusting formulas to create proprietary to distinguish the product from the competition; all while being compliant with the FDA and following 21 CFR Part 111 (GMP) and with DSHEA.

Reverse engineering provides valuable information for manufacturers to develop compliant, competitive joint health supplements.

Labeling & Structure-Function Claims

Consistent with FDA guidelines, joint health nutraceuticals may have use structure-function claims like:

Allowed examples:

  • “Supports healthy cartilage”
  • “Promotes joint flexibility and mobility”

That’s not to say, however, that disease claims like “treats arthritis” or “relieves osteoarthritis pain” are allowed. They are not. All structure-function claims must have reasonable scientific support in terms of credible scientific evidence and terminology, and all structure-function claims will require the DSHEA disclaimer.

Strategic Recommendations

  • Utilize FDA-permitted and GRAS-notified ingredients only
  • Perform NDIN testing and verify scientific safety dossiers
  • Utilize reverse formulation analytical techniques
  • Back structure-function claims with peer-reviewed literature
  • Refrain from drug-like claims or unsubstantiated efficacy citations

7.Enforcement and Penalties

The ramifications of being noncompliant could lead to:

  • Fines & Penalties
  • Recalls
  • Reduction or removal of licenses
  • Reputation loss & damaged trust
  • Business closure (in extreme cases)

Case Study

Recasting a Shellfish-Free Joint Capsule

An American company reverse-engineered a glucosamine-chondroitin product with corn-fermented glucosamine and algal calcium supplemented with MSM. The product sidestepped NDIN by exploiting GRAS routes and addressed demand from vegan consumers. The product was in line with 21 CFR 101 for labeling and 21 CFR 111 for cGMP ([FDA 21 CFR 101].

Component/Parameter

Original Product (Reference)

Reformulated Product (New Vegan Capsule)

Regulatory Notes

Glucosamine Source

Shellfish-derived Glucosamine Sulfate

Corn-fermented Glucosamine HCl

Self-affirmed GRAS; used in food and supplement markets

Chondroitin Source

Bovine-derived Chondroitin Sulfate

Omitted; replaced by Algal Calcium Complex

Algal calcium is GRAS; avoids bovine material

MSM

Present

Present

GRAS-notified; no NDIN required

Capsule Shell

Gelatin-based

Plant-based HPMC capsule

Vegan-compliant; accepted under 21 CFR Part 101

Stabilizers/Excipients

Magnesium stearate, silica

Rice concentrate, silicon dioxide

Clean-label excipients; compliant with FDA labeling norms

Structure-Function Claims

“Supports joint comfort and flexibility”

“Helps maintain cartilage and joint mobility”

Substantiated and compliant with DSHEA; paired with FDA disclaimer

Labeling

Standard supplement facts panel

Updated per 21 CFR Part 101

Included DSHEA-compliant disclaimer and allergen-free tag

GMP Compliance

21 CFR Part 111

Maintained

Full documentation of batch records, testing, CoAs

Conclusion

To conclude, FDA compliant nutraceutical ingredients and products, e.g. nutraceutical joints health supplements, require a strategic, thoughtful approach to ingredient selection, formulation, and regulatory compliance. FDA regulations allow companies to craft and formulate innovative, novel nutraceutical products, while still maintaining the highest standard of safety and efficacy, stability, and shelf-life quality. Staying ahead of the evolving regulatory landscape and compliance ensures nutraceutical joint health products will thrive in the marketplace.

Partner with FRL for FDA-compliant joint health nutraceuticals, offering ingredient sourcing, reverse formulation, stability tests, regulatory support, and label compliance. Contact us for innovation and reverse engineering assistance.

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