Safety11 min readJuly 29, 2026

CBDfx Review 2026: The FDA Warning Letter & What's Really in the Mushroom Gummies

CBDfx reviewed—one of the biggest names in CBD, with accredited lab reporting, a federal warning letter on its record, and a psychoactive product whose active ingredient is not the one on the label.

By Med Consumer Watch Team

CBDfx (cbdfx.com) is one of the largest and longest-established CBD brands in the US, selling tinctures, gummies, capsules, vape pens, topicals and pet products, plus a newer line it markets as Microdose Mushrooms. The operating company is Newhere Inc. It publishes lab reports from ISO 17025-certified laboratories and discounts aggressively—a 35% sitewide code was live when we checked. It ships within the US only and is age-restricted. We priced the catalogue on July 29, 2026. This review contains affiliate links; the assessment is our own. It is informational only and not medical advice, and two things on this site need flagging before anything about value.

The FDA Warning Letter

CBDfx is the only brand in this category we have reviewed that has a federal warning letter on its record, and the details matter. On November 16, 2022, the FDA issued a warning letter to Newhere Inc dba CBDFX following an October 2022 review of cbdfx.com; the letter was posted publicly on November 21. It named specific products: the flavoured Chill Shots in all strengths and varieties, CBDfx Mixed Berry Gummies 1500mg, and CBD Cookies with Protein 20mg in Chocolate Chip, Oatmeal Raisin and Peanut Butter. The FDA's position was that these products are adulterated under section 402(a)(2)(C)(i) of the Federal Food, Drug, and Cosmetic Act because they contain an unsafe food additive. The reasoning is categorical rather than specific to this company: CBD has not been authorised for use as a food additive, is not subject to a prior sanction, and does not meet the criteria for generally recognised as safe status—so adding it to a conventional food renders that food adulterated in the agency's view. The FDA also noted that some of the products were in forms attractive to children and could be mistaken for ordinary foods. Context is only fair. This was part of a round of letters sent to several CBD food and beverage companies as the FDA took a more aggressive line on CBD in food, and it reflects a regulatory position on the whole category as much as a judgement about one firm. Nothing in it alleged contamination or that the products were not what they said they were. But it is a documented federal action naming this brand, it concerned products designed to look like snacks, and buyers deserve to know it happened.

The distinction the FDA draws is between CBD in a dietary-supplement-style format and CBD added to conventional food—drinks, cookies, sweets. If that regulatory exposure concerns you, tinctures, capsules and topicals sit further from the line than food-format products do. And the child-appeal point is worth taking seriously in your own home regardless of the legal argument: keep anything that looks like a cookie or a sweet locked away from children.

The Mushroom Gummies Are Not Psychoactive Because of Mushrooms

CBDfx sells Microdose Mushroom Gummies at $29.99 for a single pack, prominent enough to have its own place in the site navigation. Its own product page says the gummies "may produce psychotropic effects, so please use responsibly," and defines microdosing as "taking a very small amount of a psychoactive product." So what produces the effect? The company lists the mushrooms as turkey tail, lion's mane, cordyceps and chaga. None of those is psychoactive. They are culinary and adaptogenic mushrooms with no intoxicating properties whatsoever. The psychotropic effect the page advertises must come from the other listed ingredients—and CBDfx names them: Himalayan mad honey, kanna, and yerba mate. Those first two deserve to be understood properly, because neither is a benign botanical. Mad honey is honey produced from rhododendron nectar, and it contains grayanotoxins. Grayanotoxins bind voltage-gated sodium channels and cause prolonged depolarisation, producing parasympathetic overactivity. The clinical picture, documented across a substantial medical case literature from Nepal, Turkey and elsewhere, is bradycardia and hypotension with dizziness, nausea, vomiting, sweating, blurred vision and impaired consciousness; published cases include atrioventricular block, syncope, and patients presenting with blood pressure around 60-65 systolic and heart rates in the 40s, treated with intravenous fluids, atropine and sometimes vasopressors. Reported cases have followed as little as a few teaspoons of honey. Kanna (Sceletium tortuosum) is a serotonin reuptake inhibitor. Its alkaloids mesembrine and mesembrenone inhibit the serotonin transporter in the same manner as prescription SSRIs, with mesembrenone additionally inhibiting PDE4. The standard safety guidance is that it should not be combined with SSRIs, MAOIs or other serotonergic drugs because of the risk of serotonin syndrome.

Do not take this product if you have any cardiac condition, low blood pressure, or a heart rhythm disorder, or if you take beta blockers, calcium channel blockers or any medication that slows heart rate—grayanotoxin toxicity is a cardiac event. Do not take it if you are on an SSRI, SNRI, MAOI, triptan, tramadol, lithium or any other serotonergic medication, because kanna is a serotonin reuptake inhibitor and the combination risks serotonin syndrome. Do not take it if you are pregnant, breastfeeding or under 21, and never combine it with alcohol. If you take it and develop dizziness, fainting, a slow heartbeat, persistent vomiting, agitation, tremor or fever, seek medical care and tell the clinician exactly what you took; Poison Control is available at 1-800-222-1222. A product whose psychoactive ingredient is not the one in its name is not a product you should be experimenting with.

What It Costs

Prices verified from CBDfx's own product feed on July 29, 2026, before any discount code. Note that a 35% sitewide code was displayed on the site when we checked, so these are anchors rather than what most buyers pay:

CBD + CBG Wellness tincture — $49.99 to $84.99 depending on strength
CBD + CBN Calming tincture — $84.99 to $149.99
Full Spectrum CBD capsules, 1500mg — $39.99
Full Spectrum CBD gummies, mixed berry — $54.99 to $217.99 across pack sizes
THC vape pen, 1500mg CBD with 10mg THC — $34.99 to $66.00
Microdose Mushroom gummies — $29.99 single pack, $56.98 for two
Bundles and sets — Day & Night gummy set $98.98, All-Day Calm bundle from $130.18, Nighty Night $162.72, Immunity $181.32, complete tincture set $188.97 to $458.97
Pet bundles — mobility and calming bundles $109.98 each

Never buy from this site at list price. A 35% sitewide code was running when we checked and CBDfx discounts more or less continuously, which means the posted prices function as anchors. The bundles in particular look expensive at list and reasonable after a code—work out the per-milligram cost of the discounted price before deciding a $181 bundle is good value.

The Testing Is Genuinely Solid

Set the two flags above aside and the quality infrastructure here is among the better ones in this category, which is part of what makes the rest frustrating. CBDfx states that it provides in-depth lab reports from independent, ISO 17025-certified laboratories, and it maintains a comprehensive lab reports section organised by product line—capsules, soft gels, tinctures, gummies, topicals, vapes and pets each have their own reports. ISO/IEC 17025 is the international standard for testing laboratory competence, and requiring it of your testing partner is meaningful. The brand also maintains a medical advisory page, and it has been trading since well before most of the competition. What we would like to see, and could not confirm on the reports index, is the same lot-level traceability that the strongest brands in this category offer—R&R CBD puts QR codes on packaging so you can pull the report for the exact jar in your hand. Reports organised by product line are useful; reports tied to your batch are better.

Use the lab reports section before you buy, not after. Match the product and strength you are considering, check the report measures contaminants and not only cannabinoid potency, and note the date. A large, well-organised reports library is only worth as much as the specific document behind your product.

What Changes in November

Section 781 of the Continuing Appropriations Act, 2026 redefines hemp by total THC rather than delta-9 alone and caps finished consumable products at 0.4 milligrams of total THC per container from November 12, 2026. No delay had been enacted as of the Farm Bill the House passed on April 30, 2026. CBDfx's catalogue splits on this. Products in the CBD + THC line—the vape pens listing 10mg of THC alongside 1500mg of CBD are the clearest example—are caught. Full-spectrum products contain THC by design and across a whole container will typically exceed 0.4mg total. The broad-spectrum and isolate-based products are the part of the range that sits under the new threshold. The Microdose Mushroom gummies are unaffected by this particular statute, since their psychoactive ingredients are not cannabinoids at all. That is not reassurance—it means they sit outside the hemp regulatory framework rather than safely inside it.

If you want a product you can keep buying past this autumn, choose broad-spectrum or isolate rather than full spectrum, and avoid the CBD + THC line for anything beyond near-term use. That is also the right choice if you are subject to workplace drug testing, though no product can guarantee a negative result.

Safety, Eligibility and Who Should Not Use This

The baseline position applies here as everywhere: no over-the-counter CBD product is FDA-approved for any condition, and the only FDA-approved CBD medicine is prescription Epidiolex for specific seizure disorders. In its 2022 letter the FDA also set out its safety concerns about CBD directly, citing potential for liver injury, harmful interactions with certain drugs, and effects on the reproductive system. That last point is worth stating plainly because it comes from the regulator rather than from us. CBD inhibits CYP450 liver enzymes that metabolise a long list of common medicines, making blood thinners, anti-seizure drugs, immunosuppressants and some antidepressants genuine issues to raise with a prescriber. For the mushroom gummies, the cautions in the earlier section are not general wellness advice—they are specific pharmacological risks with a case literature behind them, and they should be treated accordingly.

Do not use CBD products if you are under 21, pregnant or breastfeeding, subject to workplace or athletic drug testing, or taking prescription medication metabolised by the liver without asking your prescriber first. Avoid if you have liver disease. Keep food-format products—cookies, sweets, drinks—locked away from children, which is the specific concern the FDA raised about this brand's range. If you are treating a diagnosed condition, that warrants a licensed clinician rather than a supplement purchase.

How It Compares

Seven hemp brands reviewed now. CBDfx has more scale and a longer history than any of them, which cuts both ways. All figures from each brand's own store, checked July 29, 2026:

CBDfx — $29.99-$458.97 across a very wide catalogue, heavily discounted in practice · ISO 17025-certified laboratory reporting organised by product line · a documented 2022 FDA warning letter for adulterated food products · a psychoactive mushroom line whose active ingredients are mad honey and kanna
Joy Organics (our review: 7.7/10) — USDA organic on a defined collection, SC Labs ISO 17025, FDA-registered cGMP facility, BBB A+ · no regulatory actions we found
R&R CBD (our review: 7.6/10) — three named labs, lot-level QR-linked COAs, every batch tested, 60-day guarantee · independent testing found all products met label
Redeem Therapeutics (our review: 6.6/10) — about 2 cents per mg, 60-day guarantee, USDA organic hemp · unnamed lab and self-attested cGMP
Cheech & Chong (our review: 3.8/10) — celebrity-licensed, THCa flower and a semi-synthetic novel cannabinoid, and a drug-test claim we would ignore

Scale is not a quality signal in this category and this brand is the proof: CBDfx has better laboratory infrastructure than most of its competitors and the only federal warning letter among them. If you want CBD from a large operator with accredited testing and no regulatory history we could find, Joy Organics and R&R both clear that bar.

Honest Pros and Cons

What we would tell a friend, in both directions:

Pro — lab reports from independent ISO 17025-certified laboratories, organised comprehensively by product line
Pro — one of the longest-established brands in US CBD, with a very wide catalogue and a medical advisory page
Pro — aggressive and near-continuous discounting, so real prices are well below the listed ones
Pro — clear cannabinoid labelling, including THC content on the CBD + THC line
Pro — genuine breadth, from single tinctures to pet bundles, if you want to buy everything in one place
Con — a documented FDA warning letter to parent Newhere Inc in November 2022, citing named products as adulterated for containing an unsafe food additive
Con — the FDA specifically flagged that some products were in forms attractive to children
Con — the Microdose Mushroom gummies advertise psychotropic effects that come from mad honey and kanna rather than from any mushroom in the name
Con — mad honey contains grayanotoxins with a documented cardiac toxicity literature; kanna is a serotonin reuptake inhibitor with SSRI interaction risk
Con — list prices are anchors rather than prices, which makes value comparison harder than it should be
Con — lab reports are organised by product line rather than tied to your specific batch
Con — full-spectrum and CBD + THC products are caught by the 0.4mg-per-container cap from November 12, 2026

Who Should Pick It—and Who Should Look Elsewhere

CBDfx fits a buyer who wants a broad, one-stop CBD catalogue from an established operator with accredited laboratory reporting, who will buy the tinctures, capsules or topicals rather than the food-format or novelty lines, and who waits for one of the near-constant discount codes before checking out. On that basis it is a reasonable choice and the testing infrastructure is real. Look elsewhere if a clean regulatory record matters to you—Joy Organics and R&R both offer comparable or better verification without a warning letter on file. Look elsewhere if you want lot-level traceability you can scan from the packaging. And we would tell anyone to avoid the Microdose Mushroom gummies specifically: a product marketed on mushrooms whose psychoactive effect comes from a grayanotoxin-containing honey and a serotonin reuptake inhibitor is not something to try casually, and it is actively dangerous for anyone with a heart condition or on serotonergic medication. Nobody under 21, pregnant, breastfeeding, drug-tested, or on liver-metabolised prescription medication should be buying any of this.

Common Questions

Quick answers to what buyers actually search:

How much does CBDfx cost? — Tinctures $49.99-$149.99, 1500mg capsules $39.99, gummies $54.99-$217.99 by pack size, THC vape pens $34.99-$66.00, mushroom gummies $29.99, bundles $98.98-$458.97. A 35% sitewide code was live when we checked on July 29, 2026.
Did CBDfx get an FDA warning letter? — Yes. On November 16, 2022 the FDA wrote to Newhere Inc dba CBDFX citing flavoured Chill Shots, Mixed Berry Gummies 1500mg and CBD Cookies with Protein 20mg as adulterated for containing an unsafe food additive, and noted some products were in forms attractive to children.
Is CBDfx legit? — It is a large, long-established company publishing lab reports from ISO 17025-certified laboratories. The warning letter concerned CBD in conventional food rather than contamination or mislabelling.
What is in CBDfx Microdose Mushroom Gummies? — Turkey tail, lion's mane, cordyceps and chaga—none of which is psychoactive—plus Himalayan mad honey, kanna and yerba mate. The advertised psychotropic effect comes from the mad honey and kanna.
Is mad honey safe? — It contains grayanotoxins, which cause bradycardia and hypotension. The medical literature documents cases of syncope, atrioventricular block and hospital treatment with atropine and vasopressors after modest amounts.
Can I take kanna with antidepressants? — No. Kanna inhibits serotonin reuptake like an SSRI, and combining it with SSRIs, SNRIs, MAOIs or other serotonergic drugs risks serotonin syndrome.
Does CBDfx do third-party testing? — Yes, it publishes reports from independent ISO 17025-certified laboratories, organised by product line. We could not confirm lot-level traceability to your specific package.
Will CBDfx show up on a drug test? — Full-spectrum and CBD + THC products very plausibly will. Broad-spectrum and isolate products carry less risk but no guarantee.
Is CBD FDA-approved? — No over-the-counter CBD product is. The only FDA-approved CBD medicine is prescription Epidiolex for specific seizure disorders.

The Bottom Line

Verdict: 5.4/10—strong laboratory infrastructure attached to a catalogue with two things on it we cannot wave through. CBDfx does the testing part well: independent ISO 17025-certified laboratories, comprehensive reports by product line, a long trading history and a genuinely broad range, sold at prices that are reasonable once you apply one of its near-permanent discount codes. Against that sits a November 2022 FDA warning letter to parent company Newhere Inc naming specific products as adulterated for containing an unsafe food additive, with the agency noting some were in forms attractive to children—a category-wide regulatory position, but a documented federal action and the only one among the brands we have reviewed. And sitting in the current catalogue is a product called Microdose Mushroom Gummies whose advertised psychotropic effect comes not from turkey tail or lion's mane but from Himalayan mad honey, which contains grayanotoxins with a documented literature of bradycardia, hypotension and hospital admissions, and from kanna, a serotonin reuptake inhibitor that should not be combined with SSRIs. Buy the tinctures and capsules on a discount code if you want a large operator with accredited testing; skip the food-format products; and do not buy the mushroom gummies. This review is informational only and not medical advice; consult a licensed clinician before using any of these products, particularly if you have a heart condition, take antidepressants, or are pregnant or breastfeeding. Prices and terms checked July 29, 2026 and subject to change.

Sources & References

CBDfx — Official Site
CBDfx — product feed, product pages and lab reports section (checked July 29, 2026)
FDA — Warning Letter to Newhere Inc dba CBDFX, 629243 (November 16, 2022)
Food Safety News and Salon — coverage of the November 2022 FDA CBD warning letters
Cureus, International Journal of Emergency Medicine and PMC case literature — mad honey / grayanotoxin poisoning
Published pharmacology of Sceletium tortuosum (kanna) — mesembrine serotonin reuptake inhibition and SSRI interaction
Continuing Appropriations Act, 2026, Section 781 — federal redefinition of hemp, effective November 12, 2026
FDA — CBD regulatory status and Epidiolex approval
Poison Control — 1-800-222-1222

Medical Disclaimer

This article is for informational purposes only and is not intended as medical advice. Always consult with a qualified healthcare provider before making decisions about your health or medications. Individual experiences may vary.

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