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Everything published here, newest first: reference guides on supplement compliance, what has shipped in the product, and regulatory changes found at official sources. Each item opens its full page.
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Regulatory
FDA: ZUBB Dietary Supplement may be harmful due to hidden ingredient | FDA
The FDA advises consumers not to purchase or use ZUBB Dietary Supplement, a product promoted for weight loss. According to the FDA notice, it was identified during an examination of international mail shipments. FDA laboratory analysis confirmed the product contains sildenafil, the active ingredient in Viagra, not listed on the label. Sildenafil may dangerously lower blood pressure when combined with nitrates, especially for those with diabetes, high blood pressure, high cholesterol, or heart disease.
Regulatory
Industry press: FDA Deep Dive Into CGMPs
An FDA webinar on 21 CFR Part 111 product specifications offered compliance insights for dietary supplement manufacturers and document reviewers, according to industry press.
Regulatory
Industry press: CRN Welcomes FDA Focus on Strengthening GRAS Transparency, Calls for National Uniformity
The Council for Responsible Nutrition welcomed FDA's proposed GRAS transparency rule. CRN supports enhanced accountability for self-GRAS reviews and FDA visibility into ingredients, but warns against eliminating self-GRAS, which could stifle innovation. It proposes a GRAS ingredient registry and urges national uniformity to prevent conflicting state requirements.
Regulatory
Industry press: FDA Proposes Mandatory GRAS Notifications; Industry Weighs In
The source title indicates FDA proposed mandatory GRAS notifications, but the provided article body covers only ashwagandha health topics and does not describe any regulatory change, detail, or industry comment.
Regulatory
Industry press: Experts doubt whether FDA would have manpower to do GRAS reviews
An industry press article reports experts doubt FDA has the manpower to handle mandatory GRAS notifications if the proposed rule is finalized. This could affect how dietary supplement ingredient safety reviews are managed.
Regulatory
FDA: Revival Animal Health, LLC Voluntarily Recalls Feline Milk Replacers Due to Inconsistent Levels of Vitamins and Trace Minerals
Revival Animal Health is recalling its Breeder’s Edge® and Shelter’s Choice® Feline Milk Replacers because they contain low levels of potassium, copper, folic acid, choline, and/or pyridoxine (vitamin B6). This is a pet food recall, not a human dietary supplement action.
Regulatory
FDA: FDA Seeks Public Input to Advance Development of Botanical Drug Products
The FDA announced a request for information seeking public input on advancing botanical drug products, according to a press announcement.
Regulatory
FDA: SUPPLX.com Issues Voluntary Nationwide Recall of Business Pill and Branch Manager for Men Due to Undeclared Yohimbine
SUPPLX.com is voluntarily recalling 'Business Pill' and 'Branch Manager for Men' dietary supplements marketed for male sexual enhancement. FDA laboratory analysis found the products contain undeclared yohimbine.
Regulatory
OEHHA: Announcement of the Carcinogen Identification Committee Meeting Scheduled for November 17, 2026
OEHHA announced a November 17, 2026 meeting where the Carcinogen Identification Committee will review whether ethoprop should remain on California's Proposition 65 list of cancer-causing chemicals, according to an OEHHA notice. A 45-day public comment period on a hazard identification document ends October 19, 2026. No submissions were received during a prior information request.
Regulatory
Federal Register: Federal Register :: Advancing Development of Botanical Drug Products; Request for Information
The FDA opened a public docket (FDA-2026-N-9550) to request comments by November 3, 2026, on advancing development of botanical drug products. The agency seeks stakeholder perspectives on challenges and potential solutions in gathering information required by the FD&C Act, according to the Federal Register.
Guide
How much does supplement compliance cost per SKU per year?
The recurring cost model: TIC review vs. retest, how often it recurs, consultant rates, and what a plan costs per product, with the arithmetic shown and nothing invented.
Regulatory
FDA: HFP Constituent Updates
The FDA announced a public meeting on March 3, 2026, regarding Dietary Supplement Innovation and the Scope of Dietary Ingredients. According to the FDA's HFP Constituent Updates, this meeting concerns dietary supplement innovation and the scope of dietary ingredients.
Update
Auto-chase is now yours to switch on, on your schedule, in your words
The chase no longer runs on its own by default. What's missing is your control panel: every manufacturer and exactly what each still owes you, chased in one click. Once your catalogue, documents and a manufacturer contact are in, you can turn on auto-chase from Settings, set how many days apart it follows up, and write the request and reminder emails yourself. Its first batch still waits for your approval, and a pause switch stops everything.
Update
A welcome that tells you exactly what to do, and a two-minute tour
New accounts now get a welcome email the moment the trial starts — the private intake address to forward COAs to, who to chase, and the one approval the chase needs — and the portal opens with a first-run page that leads with that address, plus a seven-stop tour of where everything lives (restart it any time with the Tour link).
Update
One plan. Three sizes. Everything included.
Managed and Autopilot are gone as separate plans: every subscription now includes everything — the scoring, the ledger, expiry warnings, the chase running itself, multi-pass extraction, packs (retailer packs included), regulatory alerts and the assistant. The only choice is size: Starter (up to 5 SKUs), Standard (up to 15) or Unlimited, with annual billing about 20% under monthly. The guarantee is now the simple kind: change your mind in the 30 days after the first payment and it is refunded, no questions.
Update
The offer, stated: card-on-file trial, 30-day money-back, the report for an email
Every new account now picks a plan and size on one page, adds a card and starts its 14 days — $0 that day, the first payment on day 15 unless cancelled in one click — with a guarantee beside the button: change your mind in the 30 days after the first payment and it is refunded, no questions. The pricing page shows what every plan replaces and what is included on top (done-for-you setup by forwarding address, TIC and retailer packs, the evidence ledger). The free check now shows what it found for nothing and opens the full line-by-line report for an email, which also receives the report, a note on what the gaps cost, and a reminder before the link expires. Replies to any email from us reach a person: the support address on the root domain now receives.
Update
A 14-day free trial replaces the free tier; regulatory alerts and articles
Every new account now starts with full Managed access for 14 days — no card — and then chooses Managed or Autopilot, sized by SKU count; when a trial lapses nothing is deleted and everything unlocks again on choosing a plan. The regulatory watch now searches the web daily across official sources, verifies every item against its source before publishing, writes a full article on what it means for a brand, and emails paid accounts when a change touches their product types. The free single-document check stays open to everyone, no signup.
Regulatory
Federal Register: Substances Generally Recognized as Safe
The FDA is proposing a rule to make GRAS notices mandatory, with some exceptions. It would require persons introducing a human or animal food substance under the GRAS provision to notify the FDA of their safety conclusion. The rule, if finalized, aims to increase transparency and help the FDA identify potentially unsafe substances. Comments on the proposal are due by December 9, 2026.
Regulatory
OEHHA: Proposition 65: Omnibus 2026 Pre-Rulemaking
California OEHHA has released draft Prop 65 rule changes open for public comment. One change narrows the 'naturally occurring' exemption: a chemical extracted or concentrated from a plant can now count as human-caused even if it wasn't chemically altered — relevant if you sell botanical extracts. Other changes touch internet-purchase warnings and add QR codes as an approved warning method.
Regulatory
Federal Register: Listing of Color Additives Exempt From Certification; Spirulina Extract
FDA approved wider use of spirulina extract as a color additive in foods generally, including coating formulations applied to dietary supplement tablets and capsules, and tightened the allowed limits for lead, arsenic, mercury and (new) cadmium in the ingredient.
Guide
Amazon supplement verification checklist for 2026
A step-by-step checklist for Amazon supplement verification: inventory SKUs, collect documents, check the document window, choose a provider, hand over, track.
Guide
Certificate of Analysis vs. Certificate of Conformance vs. spec sheet
Three documents get confused in a compliance review: what a COA, a Certificate of Conformance, and a spec sheet each prove, and why neither replaces a COA.
Guide
Do I need a Certificate of Analysis for every lot, or just the product?
Part 111 lets a manufacturer verify finished batches on a sampling plan, not every one, but a COA is a per-lot document. What that means for your lots.
Guide
What do FDA warning letters to supplement firms actually cite?
Five real FDA warning letters to supplement firms and the recurring citations: specifications, identity testing, batch records, own-label distributor duty.
Guide
cGMP vs. GMP Certified vs. NSF Certified for Sport vs. USP Verified: what do they mean?
cGMP is a federal regulation every US supplement maker must follow. GMP Certified, NSF Certified for Sport, and USP Verified are separate, voluntary programs.
Guide
Heavy metals testing for supplements: what a reviewer looks for on a COA
Arsenic, cadmium, lead, mercury on a COA: why per-day exposure differs from concentration, why chemical form matters, and which authorities set the numbers.
Guide
How long is a Certificate of Analysis valid for Amazon's supplement verification?
Amazon's approved TIC providers accept a COA only inside a document-age window. What the window is, why sources disagree, and how to keep every SKU inside it.
Guide
How to choose an Amazon-approved TIC provider for supplements
What differs between Amazon-approved TIC providers (approval scope, turnaround, own lab or not, pricing) and prepping documents so a review passes first time.
Guide
How should I organize supplement compliance documents by lot?
A practical filing system: product, then lot, then documents. What to keep, how to name files, retention under 21 CFR 111.605, and where a spreadsheet breaks.
Guide
What is the '100 percent' identity testing rule under 21 CFR Part 111?
21 CFR 111.75(a)(1) requires identity testing on every ingredient lot, with a narrow petition exemption. What it means for a brand relying on a manufacturer.
Guide
Microbial testing for supplements: what a Certificate of Analysis should show
Total aerobic count, yeast/mold, and specified organisms on a COA: the USP <2021>/<2022>/<2023> chapters behind them, and why 'conforms' isn't a result.
Guide
What does Proposition 65 require of a supplement brand, and what changes in 2026?
California's Prop 65 warning duty, the naturally occurring exemption, how it reaches Amazon listings, and what OEHHA's Omnibus 2026 draft proposes to change.
Guide
What should a quality agreement with a contract manufacturer include?
What a quality agreement covers: specs, testing or COA delivery, record access, change notice, recall, and why Part 111 pushes toward having one.
Guide
Regulatory consultant or compliance software: do supplement brands need both?
What a consultant does that software can't (judgment, launches, remediation) and what software does that a consultant on retainer can't (watching every day).
Guide
Serious adverse event reporting: what a supplement brand is required to do
Federal law requires the label's 'responsible person' to report a serious adverse event to FDA within 15 business days, and to keep records for 6 years.
Guide
Spreadsheet or software for supplement compliance documents?
A spreadsheet tracks one manufacturer and a few SKUs fine. Where it breaks as lots and manufacturers multiply, and what knowing what's missing requires.
Guide
Structure/function claims vs. disease claims: where's the line on a supplement label?
A structure/function claim describes a body role; a disease claim implies curing one. FDA's criteria, its disclaimer, and why a listing is labeling too.
Guide
Supplement compliance software compared: the categories, as of 2026
AI label tools, cannabis COA software, retailer supplier networks, manufacturer QMS/ERP: what each does and doesn't do, from vendors' own pages, as of 2026-08.
Guide
What do Costco, Sprouts, and Thrive Market ask supplement suppliers for?
Costco, Sprouts, and Thrive Market's own public supplier pages, compared: audit standards, documents, and ingredient rules for a supplement supplier.
Guide
What happens when a supplement's Certificate of Analysis expires?
A COA doesn't legally expire, but past the document-age window it stops being reviewable. The chain to listing risk, and the 60/30/14 approach that avoids it.
Guide
What is a cGMP certificate, and how does a brand that doesn't manufacture get one?
A cGMP certificate is a third-party audit of one facility, not an FDA document. What it covers and how a non-manufacturing brand gets one.
Guide
What is a TIC provider, and why does Amazon require one for supplements?
What a TIC (Testing, Inspection and Certification) provider is, what it reviews for Amazon verification, and why sellers can't submit documents directly.
Guide
What is an NDI notification, and when does a supplement need one?
A new dietary ingredient wasn't marketed in a US supplement before October 15, 1994. The 75-day notification, who files it, and what to ask a manufacturer.
Guide
What does Whole Foods Market ask supplement suppliers for?
What Whole Foods Market's own pages say a supplement supplier must provide: ingredient standards, claims rules, insurance, and where the pages stay silent.
Guide
What is 21 CFR Part 111, and what does it mean for a brand that doesn't manufacture?
FDA's cGMP rule for supplements sets no numeric limits: it requires specifications, identity testing, a quality unit, and records. Outsourcing does not move it.
Guide
What does Amazon require for supplement listings in 2026?
Every dietary supplement listing on Amazon now requires third-party cGMP verification through an Amazon-approved TIC provider. What sellers must have ready, how the TIC Direct Validation path works, and what verification costs.
Guide
What should you do when an Amazon listing is suspended over documentation?
A step-by-step response plan for supplement listing suspensions: read the notification precisely, audit what you hold, engage a TIC provider, commission testing if needed, and respond inside the stated window.
Guide
How do you read a Certificate of Analysis?
The anatomy of a supplement COA: header and accreditation, sample identification, the results table, non-detect notations, why 'Conforms' is not a result, and what makes a COA unusable for verification.
Guide
What is your contract manufacturer responsible for, and what stays yours?
The cannot-contract-out doctrine for supplement brands: the manufacturer holds the records, the brand holds the liability. What to expect a contract manufacturer to provide, and which duties no contract can transfer.
Guide
How does TIC verification work and what does it cost?
The Amazon TIC verification flow step by step: provider choice, document handover, authenticity checks, direct submission, with current review and retest cost figures and the seven reasons submissions bounce.
Guide
Which compliance questions should you ask before signing a contract manufacturer?
Seven compliance questions to put to a contract manufacturer before signing: registration attestation, cGMP certification and issuer, per-lot COA scope, document turnaround, quality agreements, spec-change handling, and a sample document set.
Update
One-click onboarding, a free tier, and the real requirements library
Populate your whole catalogue without typing it: connect Amazon (Selling Partner API, not scraping), import from your website, drop a folder of COAs, or upload a spreadsheet — each proposes products, lots and manufacturers for you to confirm. A permanently free tier now shows your readiness score, how many SKUs have issues, and your total dollar exposure; paid plans unlock which SKUs and what each one needs, the expiry calendar, chasing, packs, and more. Your data is always yours — export everything, on any plan, any time. The requirements library is now backed by the verified regulatory dataset, with every value carrying its primary-source citation.
Update
Initial release
The free gap check: upload Certificates of Analysis, get a per-document result with the cost of fixing it. Document extraction with human review — every value carries its source location, and nothing is guessed. The requirements library, with the authority and citation visible on every line. Staleness tracking against the configured COA validity window, with warnings before anything expires. Manufacturer request links — a no-login page your manufacturer can upload to. TIC and retailer packs: everything a reviewer needs, assembled in one step.