Making OTC Topical Drugs In Kitchen Stirs Up Problems For Oregon Firm

FDA expects Pain Relief Naturally to recall lidocaine-containing hemorrhoid, bed sore and pre-tattoo lotions and sprays. In addition to GMP problems, formulations and labeling for Naturally Healthy Living brand products are noncompliant with US FDA's for external analgesic OTC monograph and other agency rules.

Making lidocaine-containing OTC topical anesthetics in a kitchen is just one problem FDA found at a Salem, Ore., firm, according to a recent warning letter that lists numerous current manufacturing practices violations.

The Oct. 13 letter from the Los Angeles District of FDA's Office of Regulatory Affairs also states that the agency expects Ridge Properties LLC, which does business as Pain Relief Naturally, will recall products noted as noncompliant and that it will hire a consultant to become compliant.

"Concerning the drugs that you have distributed, your written response to this letter should specify actions you will take, such as notifying customers and recalling products," ORA stated in the letter published Oct. 25.

FDA warned Pain Relief Naturally about violative claims including "provides the Legal Maximum Of Over The Counter Lidocaine" for is "Extra Strength Naturally HL Hemorrhoid Numbing With Lidocaine."

The letter explains that Pain Relief Naturally markets misbranded and unapproved new drugs due to the indications stated on product labels. Formulations and labeling for lotions and sprays marketed under the firm's Naturally Healthy Living brand and indicated for treating hemorrhoids and bed sores and to numb skin before a tattoo is applied are not compliant with FDA's OTC monograph for external analgesic drug products and other agency rules for the product category, ORA said.

Among the GMP problems ORA found at Pain Relief Naturally was failing to have separate areas within its kitchen to prevent contamination or mix-ups during production.

"Your firm manufactures drug products in a kitchen," and mixes ingredients with utensils and cookware including a steel pot, blender and kitchen spatula, ORA stated.

Its investigator found conditions and practices at Pain Relief Naturally that increase the risk of drug products containing harmful and insanitary contaminants. "For example, you had a window open to the outside for ventilation during production. You also stored cleaning equipment near formulation ingredients without adequate controls to prevent contamination," according to the letter.

Natural But Unknown?

Pain Relief Naturally's Natural HL products also are labeled with the ingredient "NatureCaine." The labels do not state its formulation, but say it is "An Unrivaled Special Blend Of Nature’s Strongest Anorectal numbing and healing treatments Naturally HL provides the Legal Maximum Of Over The Counter Lidocaine Numbing Treatment For Hemorrhoids."

FDA's warning letter does not explicitly question the makeup of NatureCaine. Instead, ORA noted that the brand's website includes a claim that the ingredient propolis is an “unrivaled organic healing agent … a must have for any recovery.”

While Natural HL product labels do not list propolis as an active ingredient the website claim for it "demonstrates that this is an 'active ingredient' as defined" by FDA regulations, which do not recognize propolis as an active ingredient in the anorectal drug final rule, ORA stated.

The manufacturer and marketer's failure to test each batch of products for conformance to final specifications, including identity and strength of each active ingredient, also prompted ORA's admonishment The letter noted that Pain Relief Naturally's CEO advised ORA's inspector that the business does not test any topical analgesic drug products it manufactures (see table below for other GMP problems ORA reported).

The company did not respond to a request for comment on the warning letter.

New Use For Lidocaine

The company's "Extra Strength Naturally HL Hemorrhoid Numbing With Lidocaine" cream is labeled as "temporarily relieves pain” and is described on the Naturally HL brand's website with claims including "provides the Legal Maximum Of Over The Counter Lidocaine Numbing Treatment for Hemorrhoids."

However, lidocaine is not an approved ingredient in FDA's final rule for anorectal drug products and the indication also is violative. "Furthermore, we are not aware of sufficient evidence to show the product as formulated and labeled is generally recognized as safe and effective," rendering it a new drug, the letter explains.

GMP Omissions Add Up

FDA's Office of Regulatory Affairs says Pain Relief Naturally failed to:

• establish and follow written procedures describing the handling of all written and oral complaints regarding a drug product;
• establish an adequate quality control unit with applicable procedures and the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling and drug products;
• prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced;
• establish adequate written procedures for production and process control designed to assure that the drug products it manufactures have the identity, strength, quality, and purity they purport or are represented to possess.

Similarly, Pain Relief Naturally's “Extra Strength Naturally HL Bed Sore Relief Cream With Added Lidocaine” and “Extra Strength PreTAT Gel With Added Lidocaine” are noncompliant with FDA's tentative final monograph for OTC external analgesics due to their formulations and indications; those problems also make the products unapproved new drugs under FDA regulations.

While Naturally HL Bed Sore Relief Cream is labeled with the indication "temporarily relieves pain,” the labeled indication for Extra Strength PreTAT Gel is "temporarily relieves pain during tattoos.” The brand's website includes this for the gel: “Fast Acting Tattoo Numbing Power – The Deep Penetrating Numbing & Healing Blend That Kills The Many Types Of Tattoo Pain."

ORA explained in the letter that distribution of products compliant with the external analgesics TFM is allowed, although those products would be subject to reformulation or relabeling requirements if the TFM is changed when finalized. "However, [the Naturally HL] products are not labeled or formulated in accordance with the TFM."

The products' noncompliance with FDA regulations also cause them to be misbranded, including failing to bear the name and place of business of the manufacturer, packer or distributor on labels and to disclose a domestic address or telephone number for reporting adverse events to the firm.

Additionally, the labeling does not comply with nonprescription drugs labeling requirements including not stating “For external use only” and “Keep out of reach of children” warning statements in bold type and omitting the accidental overdose warning statement “If swallowed, get medical help or contact a Poison Control Center right away,” according to the letter.

From the editors of the Tan Sheet.