OTC/Supplement Combo New Safety/Efficacy Data Not Needed - Attorney Hutt

OTC/supplement combination products do not require premarket clinical trials to establish safety and efficacy if data exist on the individual ingredients, attorney Peter Barton Hutt of Covington & Burling (Washington, D.C.) asserted at the Consumer Healthcare Products Association Legal & Regulatory Conference in D.C. Nov. 30.

Combination products must pass compatibility, stability and toxicity tests, Hutt maintained, adding "if there's toxicity testing done...you don't need to redo things you can find in the literature." Manufacturers "make sure they are good products" before marketing them, he argued.

Attorney Scott Bass of Sidley & Austin (Washington, D.C.) disagreed, saying "if you have permissible combinations of active ingredients" they must meet FDA's safety requirements and have "adequate directions for use" on labeling.

Bass continued by asking Hutt whether he thought "most of the [combination] products...on the Internet are made by companies" that always take the necessary steps to assure the safety of their products. "We don't know about [some] supplement companies," he noted.

Hutt deemed that analysis "absurd," charging Bass was "presuming that someone is just putting a couple of things into a pill [that] they don't know anything about," adding "people just don't do that."

"I think the safety underpinning is the issue here," Bass countered. Attorney Nancy Buc of Buc & Beardsley (Washington, D.C.) agreed, saying "you've got to worry about the kinds of interaction and inactive ingredient issues [related to] both efficacy and safety."

Nevertheless, she said, if a company "puts two things together that have a known interaction...I am confident that FDA has got a remedy" to intervene.

FDA expressed its "serious concern" over combination OTC/supplement products in recent letters to two companies (¹ (Also see "OTC/Supplement Combinations "Serious Concern" For FDA" - Pink Sheet, 12 Jun, 2000.)). The agency urged the firms to withdraw their products while it reviewed the appropriateness of the category.

FDA suggested adding supplement ingredients to an OTC drug could impact the product's safety and efficacy and stressed the risk of adverse interactions between ingredients. Possible consumer confusion over the addition of the structure/function claim disclaimer to an OTC also was mentioned by the agency.

Bass suggested a method of circumventing FDA actions would be to market a single box carrying separate bottles of each product with appropriate labeling for both on the outer carton. He also proposed selling a beverage containing a supplement ingredient in a package with an OTC drug

Bass predicted these marketing tools would become increasingly popular in the near future. Buc supported his stance, stressing such combined packaging is legal "as long as they're correctly labeled so that people understand it."

The labeling suggestions proffered by Bass echo remarks made by Hutt in May 1999, when he averred single-pill combination products could be legally marketed with "split labels" adhering to drug and supplement labeling rules. One of the products cited by FDA in its recent letters, B.F. Ascher's Melagesic (acetaminophen and melatonin), used this approach.

Omni Nutraceuticals has been planning to launch the Inholtra Joint Pain line of analgesics containing glucosamine and chondroitin. The firm, which has been consulting with FDA over labeling, said its tack was to list the supplements as inactive ingredients and not include a structure/function claim on the label, relying on consumer recognition of the ingredients' purported joint health benefits (² (Also see "Omni Nutraceuticals" - Pink Sheet, 10 Jul, 2000.)).

Bass and Hutt agreed that OTC/supplement combos are legal, and Bass noted FDA long has acknowledged products applicable to both categories, such as antacids labeled as calcium supplements. J&J/Merck earlier this year began promoting its Mylanta CalciTabs chewable antacid as a calcium supplement (³ (Also see "Mylanta CalciTabs Antacid/Calcium Supplement Benefits Featured In TV Ad" - Pink Sheet, 21 Feb, 2000.)).

Widespread confusion over this issue led the National Nutritional Foods Association in August to request an FDA guidance on what is permitted (⁴ (Also see "OTC/Supplement Combination Marketing Guidance Requested By NNFA" - Pink Sheet, 4 Sep, 2000.)).

Bass predicted FDA would modify the definition of a drug product within 10 years in a way that would clarify this issue and others related to supplements and functional foods. Hutt expressed strong disagreement, insisting the definition never would change.